[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Supernus Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":164},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,71,92,119,143],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100577484","phase-2-renaissance-2-spn-817-phase-2-double-blind-placebo-controlled-study-in-adults-with-focal-onset-seizures-100577484",false,"NCT06798896","RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures","RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults With Focal Onset Seizures","Inclusion Criteria:\n\n1. Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy Study Consortium, Inc (ESCI);\n2. Failed to achieve sustained seizure freedom after ≥2 tolerated, appropriately chosen, and adequately dosed ASM drug schedules;\n3. Able to keep accurate Seizure electronic diaries \\[eDiaries\\] (with the aid of a caregiver as needed);\n4. Has a body mass index (BMI) between 18.0 and 40.0 kg\u002Fm2;\n5. Treatment with a stable dose of 1 to 4 current ASMs for ≥28 days prior to screening. If following a diet plan along with the ASM, the participant should have been on a stable diet plan for at least 1 month prior to Visit 1. The diet plan should be maintained throughout the duration of the study;\n6. At least 4 clinically observable focal onset seizures accepted by the ESCI prior to the first dose of SM (during the days of baseline Seizure electronic diary \\[eDiary\\] data collection) and no more than a consecutive 21-day period that was free of these seizures. To be eligible for the study, participants must comply with the eDiary on at least 80% of the days of baseline data collection;\n\nExclusion Criteria:\n\n1. Has taken huperzine A within the past 6 months;\n2. Prior diagnosis of combined focal and generalized epilepsy syndrome as evidenced by severe developmental delay and multiple seizure types and confirmed by electroencephalography (EEG) (eg, Lennox-Gastaut syndrome). Participants should also be excluded in case of nondiagnostic information;\n3. History of or current nonepileptic events that could be confused by the participant and\u002For study staff as epileptic seizures;\n4. Only has seizures that are difficult to count; for example, seizures that are not clinically observable;\n5. History of uncountable seizures, such as seizures that happen in a cluster that are too rapid to be counted individually;\n6. History of status epilepticus within 6 months prior to screening;\n7. Vagus nerve stimulation, deep brain stimulation, responsive neurostimulator system, or other neurostimulation for epilepsy device implanted or activated within 1 year prior to screening; or epilepsy surgery within 1 year prior to screening. Stimulation parameters for devices must have been stable for at least 3 months prior to Screening. Battery change for any epilepsy devices will be allowed; however, stimulation parameters must remain stable during the duration of the study;\n8. Any suicidal behavior or suicidal ideation related to item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS assessment in the 1 year before screening; a suicide attempt in the last 2 years before screening; or more than 1 lifetime suicide attempt;\n9. Chronic concomitant therapy with non-ASMs that have potent cholinergic (central or peripheral) or potent central (only) anticholinergic pharmacology.\n10. History of \\>2 allergic reactions to an ASM or 1 serious hypersensitivity reaction to an ASM;\n11. Any other reason which, in the opinion of the Investigator, would prevent the participant from taking part in the study.","ALL","18 Years","70 Years",{"count":20,"type":21},216,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.",[27],"Focal Onset Seizures",[29,30,31,32],"focal seizures","focal epilepsy","Phase 2","anti-seizure medication","RECRUITING","2026-05-28",{"date":36,"type":37},"2026-06-01","ACTUAL",{"date":39,"type":37},"2024-12-30",{"date":41,"type":21},"2027-08",{"name":43,"class":44},"Supernus Pharmaceuticals, Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100479099","phase-2-safety-and-tolerability-study-of-spn-817-in-adult-patients-with-treatment-resistant-epilepsy-100479099","NCT05518578","Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy","RENAISSANCE Study: A Phase 2, Multicenter, Open Label Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy","Inclusion Criteria:\n\n1. A diagnosis of treatment resistant epilepsy as adjudicated by the Epilepsy Study Consortium.\n2. Is male or female, aged 18 to ≤ 70 years at screening.\n3. Is able to read, understand, and sign the Informed Consent Form (ICF). If the participant is unable to sign informed consent, a Legally Authorized Representative (LAR) will complete the ICF.\n4. Ability to keep accurate seizure diaries (with the aid of a caregiver as needed).\n5. Weight within the normal or overweight ranges according to accepted values of the Body Mass Index Chart (18.0 to 40 kg\u002Fm2).\n6. Is able to swallow capsules whole without crushing, chewing, or cutting.\n7. Is willing to adhere to all study procedures and able to attend study visits within the specified time windows.\n8. Failure of at least 2 tolerated, appropriately chosen and adequately dosed ASM drug schedules to achieve sustained seizure freedom.\n9. Taking at least 1 ASM at Screening and Baseline. If following a diet plan along with the ASM, the participant should have been on a stable diet plan for at least 1 month prior to screening (Visit 1). The diet plan should be maintained throughout the duration of the study. Participants on a ketogenic diet will not be permitted to participate in the intense PK group.\n10. At least 4 seizures accepted by the Epilepsy Study Consortium for the secondary outcome (adjudicated as \"probable seizures\" that are countable) during the 42-day baseline seizure diary period, and no more than a 21-day period that was seizure-free.\n11. A clinical diagnosis of Focal Cortical Dysplasia (FCD) Type I or Type II (approximately n=10) confirmed by:\n\n    1. Likely FCD supported by neuroimaging that has been performed in the last 5 years, or\n    2. History of surgical resection of the cortical dysplasia that is histopathologically confirmed in patients who continue to have uncontrolled seizures without a compelling alternate explanation for ongoing seizures.\n\n    Note: The Epilepsy Study Consortium will review to confirm FCD\u002Fprobable FCD diagnosis.\n12. Be in good general health as per PI's judgment based upon medical history, physical exams, standard 12-lead ECG, and clinical laboratory evaluations obtained during the Screening Period\n13. Be able to comply with and complete all study-specified procedures; enrollment for participants with limited ability to complete self-reported questionnaires or cognitive assessments may be permitted on a case-by-case basis after approval by the MM and Sponsor\n14. Non-pregnant females of childbearing potential (FOCP) who are either in an exclusive same-sex relationship or sexually inactive (abstinent), or if sexually active with a male partner who is biologically capable of having children, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose of SPN-817, throughout the study, and for 30 days following the last dose:\n\n    1. Simultaneous use of male condom and intra-uterine contraceptive device (IUD) placed at least 4 weeks prior to first SPN-817 administration\n    2. Surgically sterile male partner (6 months minimum)\n    3. Simultaneous use of any male barrier (condom) combined with any female barrier\n    4. Established hormonal contraceptive\n\n    Female participants are considered not to be of childbearing potential if they are either postmenopausal (amenorrhea for at least 2 years and serum follicle-stimulating hormone \\[FSH\\] level of \\>40 IU\u002FL) or permanently sterilized (eg, bilateral tubal ligation, hysterectomy, bilateral oophorectomy) for 6 months minimum.\n15. Males must:\n\n    1. Use 2 methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from the screening visit to 90 days after the last dose of SPN-817, or\n    2. Have been surgically sterilized (6 months minimum) prior to the screening visit\n    3. Refrain from donating any sperm from the first administration of SPN-817 until 90 days after the last dose of SPN-817\n    4. Males who are in same-sex partner relationships or with those who are not biologically capable of having children are required to use a condom from the first dose through 7 days after the last dose of the SM.\n\nExclusion Criteria:\n\n1. Has taken huperzine A within the past year\n2. Is planning to become pregnant or impregnate spouse, not using an acceptable method of birth control (defined as use of double-barrier birth control methods, use of oral contraceptives, or surgical sterilization), pregnant, or nursing.\n3. Participants with Lennox-Gastaut syndrome. Participants should also be excluded in case of nondiagnostic information.\n4. Has non-epileptic events that could be confused by the patient and\u002For study staff as epileptic seizures.\n5. Has only seizures that are difficult to count; for example, has seizures that are not clinically observable.\n6. Has a history of only seizure clusters, for example, seizure clusters defined as multiple seizures with at least one seizure within 30 minutes of the previous seizure.\n7. Has a history of status epilepticus in the 6 months prior to Screening.\n8. Change in ASM regimen in the last 28 days prior to screening. No changes in ASMs are allowed during the Screening, Titration\u002FOptimization, or Maintenance Period. Changes in ASM regimen (including any diet plan used as an ASM) are allowed during the OLE Period only.\n9. Vagus nerve stimulation (VNS), deep brain stimulation (DBS), responsive neurostimulator system (RNS), or other neurostimulation for epilepsy device implanted or activated \\\u003C1 year prior to screening; stimulation parameters that have been stable for \\\u003C3 months; or epilepsy surgery \\\u003C1 year prior to screening.\n10. Any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS in the 2 years before screening; a history of suicide attempt in the last 2 years; or more than 1 lifetime suicide attempt.\n11. Any condition that may impact a patient's ability to follow study procedures or a patient's safety, based on what is known about the pharmacology\u002Ftoxicology profile of the trial agent(s).\n12. Has a pre-existing medical condition (including an existing progressive or degenerative neurological disorder including brain tumor, active encephalitis, active meningitis or abscess) or takes medications that, in the PI's opinion, could interfere with the patient's suitability for participation in the study.\n13. Has a history or evidence of current significant psychiatric disturbance (e.g., schizophrenia, schizoaffective, or bipolar disorder) that would preclude meaningful participation in the study procedures.\n14. Has a history in the past 2 years or evidence of current alcohol and\u002For substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th edition.\n15. Has had any clinical laboratory abnormalities within the 2 months prior to screening considered of clinical significance by the PI.\n16. Is human immunodeficiency virus (HIV)\u002FHepatitis B\u002FHepatitis C positive or has a positive urine drug screen (UDS) with the following considerations:\n\n    1. Participants who have a diagnosis of cannabis use disorder (per DSM-5) within 6 months before Screening and have a positive UDS for cannabis at Screening will be excluded. At the discretion of the Sponsor, recreational use of cannabis is allowed and should be kept consistent during the study. Participants must agree to refrain from using cannabis 48 h prior to the study visits.\n    2. Cannabis (including cannabidiol \\[CBD\\] products) prescribed for a medical condition or used as an ASM is allowed if taken at a stable regimen for at least 28 days prior to Screening. Newly prescribed cannabis treatment and\u002For a change to the existing regimen is prohibited. When applicable, participants should show proof of their prescription for medical cannabis.\n    3. Participants who also test positive for specific medications (benzodiazepines, amphetamines, etc.) must show proof of the prescription and should not be excluded due to a positive UDS if the positive UDS is related to a prescribed medication.\n17. Is on concomitant therapy with non-ASMs that are cholinergic prior to Visit 5\n18. Is currently taking or within the 3 days prior to first administration of SPN-817 has taken over-the-counter supplements containing epigallocatechin gallate (EGCG) such as concentrated green tea extracts or products containing synthetic EGCG, or foods containing \\> 100 grams of carob powder. Also current or within the 3 days prior the first administration of SPN-817, excessive consumption (\\> 3 cups per day) of foods or drinks containing EGCG (eg, all green, white, or oolong teas and all black teas) is prohibited.\n19. Has participated in any clinical investigational drug or device study within 4 weeks prior to study entry or within 5 half-lives of the clinical investigational drug, whichever is longer.\n20. Clinically significant cardiologic abnormalities at screening. One repeat assessment is allowed per Investigator discretion.\n\n    Abnormal ECG that is, in the Investigator's opinion, clinically significant including:\n    1. Heart rate (HR) \\\u003C50 bpm\n    2. PR interval \\>220 ms\n    3. QRS interval ≥120 ms\n    4. QTcF (QT interval corrected for heart rate using Fridericia's method) \\>450 ms for males and \\>470 ms for female participants\n    5. Second or third-degree atrioventricular block\n    6. Any rhythm, other than sinus rhythm, that is interpreted by the Investigator to be clinically significant\n21. Has abnormal renal function as demonstrated by estimated glomerular filtration rate (eGFR) of \\\u003C60 mL\u002Fmin according to the eGFR Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening.\n22. Clinically significant vital signs abnormalities (systolic blood pressure \\\u003C90 or \\>140 mmHg, diastolic blood pressure \\\u003C50 or \\>90 mmHg, or HR \\\u003C50 or \\>100 bpm) at screening.\n23. Participant has had \\>2 allergic reactions to an ASM or 1 serious hypersensitivity reaction to an ASM.\n24. Participants who donated 50-499 mL of blood within 30 days or \\>499 mL within 56 days prior to Day 1 administration or have hemoglobin \\\u003C128 g\u002FL (male) or \\\u003C115 g\u002FL (female) and hematocrit \\\u003C0.37 L\u002FL (males) or \\\u003C0.32 L\u002FL (female) at screening. Following screening and throughout the study, participants should not donate blood.\n25. Any reason which, in the opinion of the PI, would prevent the participant from participating in the study.",{"count":54,"type":21},60,[24],"This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures",[58,59],"Epilepsy","Seizures, Epileptic",[32,61,29,31],"epilepsy","2026-04-16",{"date":64,"type":37},"2026-04-21",{"date":66,"type":37},"2023-02-07",{"date":68,"type":21},"2027-12-31",{"name":43,"class":44},10,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":45},"100610367","phase-2-double-blind-placebo-controlled-study-in-adults-with-major-depressive-disorder-100610367","NCT07226661","Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SPN-821 as an Adjunctive Therapy in Adults With Major Depressive Disorder","Inclusion Criteria:\n\n* Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI\n* Duration of current MDE of at least 8 weeks\n* MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit\n* CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit\n* Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement in depressive symptoms) as confirmed by the ATRQ Investigator administered.\n\nExclusion Criteria:\n\n* MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit\n* History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE\n* History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit\n* Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion\n* Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I\u002FII disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study\n* Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening.\n* History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion\n* Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function.\n* Requires treatment with a medication or other substance that is prohibited by the protocol.",{"count":79,"type":21},230,[24],"This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder",[83],"Major Depressive Disorder (MDD)","2026-03-19",{"date":86,"type":37},"2026-03-24",{"date":88,"type":37},"2026-01-19",{"date":90,"type":21},"2027-01-31",{"name":43,"class":44},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100422462","phase-4-evaluation-of-spn-812-viloxazine-extended-release-capsule-in-preschool-age-children-with-adhd-100422462","NCT04781140","Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD","A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit\u002FHyperactivity Disorder (ADHD)","Inclusion Criteria:\n\n1. Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy.\n2. Subject's parent(s) or legal guardian(s)\u002Frepresentative(s) is (are) willing and able to provide written informed consent before completing any study related procedures.\n3. Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL).\n4. Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).\n5. Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).\n6. Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.\n7. Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home.\n8. Has not initiated any behavioral intervention\u002Ftherapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention\u002Ftherapy during the study (e.g., subject is eligible if behavioral intervention\u002Ftherapy is initiated 30 or more days prior to Visit 1 \\[Screening\\] and continues with a similar duration\u002Ffrequency throughout their study).\n9. Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion\u002Fexclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate.\n10. Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.\n11. Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening).\n12. Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).\n\nExclusion Criteria:\n\n1. Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and\u002For impact study results.\n2. Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and\u002For febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor.\n3. History of Bipolar Disorder diagnosed in a first degree relative.\n4. Has global development delay or intellectual disability by medical history.\n5. Has a current diagnosis of a significant (per Investigator's evaluation and\u002For judgement) systemic disease.\n6. Has body mass index \\> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).\n7. Has a mean resting systolic and diastolic blood pressure\\* that are both \\>95th percentile for age sex, and height and has a mean resting pulse rate\\* that is \\>95th percentile for age and sex (males: \\>117 bpm; females: \\>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \\* Note: The mean of three measurements while seated.\n8. Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).\n9. Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine.\n10. Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.\n11. Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study.\n12. Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication).\n13. Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline).\n14. Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study.\n15. Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.\n16. Has suicidal ideation (\"Yes\" indicated on C-SSRS question 4 or 5) or suicidal behavior (\"Yes\" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide (\"Yes\" indicated on C-SSRS for lifetime).","48 Months","69 Months",{"count":102,"type":21},286,[104],"PHASE4","This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.",[107],"Attention-Deficit\u002FHyperactivity Disorder",[109],"ADHD","2026-02-16",{"date":112,"type":37},"2026-02-18",{"date":114,"type":37},"2024-03-19",{"date":116,"type":21},"2026-06",{"name":43,"class":44},47,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100609849","real-world-patient-experiences-using-continuous-subcutaneous-apomorphine-infusion-onapgotm-in-the-united-states-100609849","NCT07219927","Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:","Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease","Inclusion Criteria:\n\nParticipant has received a prescription for ONAPGO™ according to the standard of care.\n\nParticipant has opted into receiving support services from the Clinical Nurse Navigator (CNN), a registered nurse specially trained to work with persons with Parkinson's disease, as noted on the Prescription Enrollment Form.\n\nThe HCP\u002FInvestigator determines the participant is an appropriate study participant.\n\nParticipant is able and willing to provide informed consent (or informed assent form \\[IAF\\], as applicable) and signs the consent form on the Enrollment Day.\n\nExclusion Criteria:\n\nDid not receive a prescription for ONAPGO™.\n\nPrescribed ONAPGO™, but the HCP\u002FInvestigator determines the participant should not participate in this observational study.\n\nConcomitant use of ONAPGO™ with 5-HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) or alosetron.\n\nKnown hypersensitivity to apomorphine or to excipients of ONAPGO™, including sulfite (e.g., sodium metabisulfite).",{"count":127,"type":21},120,"OBSERVATIONAL","Real-World Participants Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease",[131],"Parkinson Disease",[133],"ONAPGO","2025-10-21",{"date":136,"type":37},"2025-10-22",{"date":138,"type":37},"2025-03-31",{"date":140,"type":21},"2027-08-01",{"name":43,"class":44},5,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":163,"locationsCount":45},"100603808","phase-2-spn-817-open-label-extension-study-in-adults-with-focal-onset-seizures-100603808","NCT07141329","SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures","An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures","Inclusion Criteria:\n\n1. Completed antecedent SPN-817 double-blind study\n2. Taking a stable dosage regimen (maintained during the antecedent study) of at least one antiseizure medication (ASM) and no more than 4 ASMs\n\nExclusion Criteria:\n\n1. Has current nonepileptic events that could be confused by the participant and\u002For study staff as epileptic seizures\n2. Has any suicidal behavior or suicidal ideation related to Item 4 (active suicidal ideation with some intent to act without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments in the antecedent study and at Visit 1 or more than one lifetime suicide attempt.",{"count":151,"type":21},100,[24],"This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.",[27],[29,30,156,32],"open-label extension","2025-10-06",{"date":159,"type":37},"2025-10-10",{"date":161,"type":37},"2025-07-30",{"date":68,"type":21},{"name":43,"class":44},""]