[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azurity Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100557160","phase-4-study-of-the-pharmacokinetics-safety-and-tolerability-of-zonisade-in-children-1-month-to-17-years-of-age-with-partial-onset-seizures-100557160",false,"NCT06534502","Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Zonisamide Oral Suspension (100 mg\u002F5 ml) to Determine a Dosing Regimen in Children 1 Month to 17 Years of Age With Partial-onset Seizures","Inclusion Criteria:\n\n* Pediatric participants (ages 1 month to 17 years of age, inclusive) will be considered eligible for the study based on the following criteria:\n\n  1. Voluntarily obtained informed consent from parent\u002Flegal guardian of the participant and assent from the participant, when appropriate.\n  2. Willing and able to follow protocol specific requirements.\n  3. Participant of 1 month to 17 years of age, inclusive (at time of consent).\n  4. Participant diagnosed with partial-onset (focal) seizures, with or without secondary generalization as per current International League Against Epilepsy (ILAE) classification of seizures. Participants with both focal-onset and generalized-onset seizures are eligible, but only focal-onset seizures count toward baseline seizure enrollment criteria. Tonic-clonic and tonic seizures with unknown onset are presumed to be focal-onset unless there are clear clinical and EEG data suggesting generalized-onset.\n  5. Participant with seizure occurrence more than once in the past three (3) months and more than two (2) times in the past six (6) months.\n\n     a. Participant who is 6 months of age and younger will have seizure profiling patterns assessed by the Investigator for appropriate consideration and inclusion in the study.\n  6. Participant on a stable regimen of anti-epilepsy drugs (AEDs) for at least 30 days before screening\n\n     a. Participant who is 6 months of age and younger will have regimen assessed for inclusion in the study at Investigator's discretion.\n  7. Participant with acceptable laboratory investigations:\n\n     1. Hemoglobin within normal range\n     2. Alanine aminotransferase (ALT) within normal range\n     3. Aspartate aminotransferase (AST) up to 1.5 x upper limit of normal (ULN)\n     4. Bilirubin within normal range\n     5. Creatinine clearance within normal range\n  8. If male participant is able to father children must be willing to use a highly effective method of contraception for at least one month after the last dose of investigational product if at risk of pregnancy with her\u002Fhis partner. If female participant has reached menarche, the participant is authorized to participate in this clinical study if additional criteria are met.\n\nAt screening:\n\n1. (i) Participant reports sexual abstinence for the prior 3 months or reports use of at least 1 of the acceptable methods of contraception, including an intrauterine device, barrier methods (e.g., male or female condom), hormonal contraceptives (e.g., hormonal patches, vaginal devices, oral pills), levonorgestrel intrauterine system (e.g., Mirena®), or regular medroxyprogesterone injections (e.g., Depo-Provera®); or (ii) Participant agrees to initiate sexual abstinence from the time of screening until at least one month after end of treatment with study drug; and\n2. Participant is advised to avoid conception from the time of screening until at least one month after last receipt of study drug and agrees not to attempt pregnancy from the time of screening until at least one month after end of treatment with study drug; and\n3. Participant is provided guidelines regarding continuation of abstinence, initiation of abstinence, or about allowed contraception; and\n4. Participant has a negative serum β-human chorionic gonadotropin (β-hCG) test just prior to study entry. Since serum tests may miss an early pregnancy, relevant menstrual history and sexual history, including methods of contraception, should be considered. Note: if the result of the serum β-hCG test cannot be obtained prior to dosing of investigational product, a participant may be enrolled on the basis of a negative urine pregnancy test, though a serum β-hCG test result must still be obtained.\n\nExclusion Criteria:\n\n* Pediatric participant will be excluded from the study based on the following criteria:\n\n  1. Known hypersensitivity to zonisamide or to any component of the investigational product or to sulfonamides.\n  2. Participant who is pregnant or nursing.\n  3. Participant with exclusively generalized-onset seizures.\n  4. Participant with predisposition to nephrolithiasis or prior history of kidney stone(s).\n  5. Participant who is underweight (weight-for-age \\\u003C2 standard deviation (SD) from the median of the World Health Organization (WHO) Child Growth Standards) or have a decreased appetite.\n  6. Participant currently on or scheduled to receive carbonic anhydrase inhibitors such as topiramate or acetazolamide.\n  7. Participant currently on or are scheduled to receive drugs known to have pharmacokinetic (PK) interaction.\n  8. Participant who has previously received zonisamide.\n  9. Participant with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).\n  10. Participant who has degenerative or metabolic disease of the brain.\n  11. Participant with history of psychiatric disorder (excluding stable attention deficit hyperactivity disorder (ADHD), mood disorder on adequate treatment).\n  12. Participant has any condition which, in the Investigator's opinion, would make it unsafe for the participant to participate in this study.\n  13. Participant who has participated in other clinical study 30 days prior to enrollment in this study or 4-5 half lives of investigational drug, whichever is longer.\n  14. Participant who uses alcohol or is currently on or scheduled to receive other central nervous system (CNS) depressants.\n  15. Participant has a positive COVID-19 polymerase chain reaction (PCR) test result; or has had exposure (within 2 weeks prior to screening) to someone who had a positive COVID-19 test result; or is suspected of having long COVID-19 by the Investigator or designee.\n  16. Participant who is missing more than 15% of daily diary entries during the screening period.","ALL","1 Month","17 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures. The study consists of four periods: a Screening Period (about 14 days), a Titration Period (8 weeks), a Maintenance Period (4 weeks), and a Follow-Up Period (1 week).",[27,28,29,30,31,32,33],"Seizures","Seizures, Focal","Seizure, Partial Onset","Seizure Disorder, Partial","Seizure, Partial","Epilepsies, Partial","Epilepsy",[35,36,37,38],"Partial-onset (focal) seizures","Pediatrics","ZONISADE","Zonisamide","NOT_YET_RECRUITING","2026-06-02",{"date":42,"type":43},"2026-06-04","ACTUAL",{"date":45,"type":21},"2026-09",{"date":47,"type":21},"2027-09",{"name":49,"class":50},"Azurity Pharmaceuticals","INDUSTRY",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100618201","phase-4-ambulatory-blood-pressure-monitoring-abpm-study-in-hypogonadal-men-100618201","NCT07328542","Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men","A Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men","Inclusion Criteria:\n\n* Male subjects aged ≥18 to ≤75 years of age (inclusive) at time of enrollment.\n* Body mass index (BMI) ≥17 kg\u002Fm\\^2 to \\\u003C 40 mg\\^2.\n* Willing and able to voluntarily provide written informed consent prior to initiation of screening or study-specific procedures.\n* Able to understand and to follow the protocol requirements, restrictions, and instruction, in the Investigator's opinion\n* Diagnosed with primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).\n* Hypogonadal males (individual serum testosterone concentrations \\\u003C350 ng\u002FdL and mean serum testosterone concentrations \\\u003C300 ng\u002FdL, determined from at least two samples separated at least 48 hours apart and obtained between 6 AM and 10 AM local time).\n* Testosterone therapy naïve or has discontinued current treatment and completed adequate washout of prior androgen therapy or any other therapy which causes significant change in serum androgen level i.e., clomiphene, anabolic steroids, compounded or over-the-counter androgenic steroid derivatives and dehydroepiandrosterone (45 days or 5 half-lives of the drug, whichever is longer, prior to collection of baseline serum testosterone samples). Washout must be completed prior to collection of baseline serum testosterone samples to determine study eligibility.\n* An office blood pressure measurement \\\u003C140 millimeters of mercury (mmHg) for SBP AND \\\u003C90 mmHg for DBP.\n* If the subject is on an antihypertensive regimen, he has been on stable dose for at least 4 weeks prior to study enrollment.\n* If the subject is on glucocorticoids \\>7.5 mg prednisone equivalent per day (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg), he has been on stable dose for at least 4 weeks prior to study enrollment with no intention of changing dose for the duration of the study.\n* Subjects with acceptable laboratory parameters\n\n  1. Hematocrit ≤ Upper limit of normal (ULN)\n  2. Hemoglobin ≤ 16 gm%\n  3. Prolactin ≤ ULN\n  4. PSA ≤ 4.0 ng\u002FmL (PSA level between 1.5 to 4.0 ng\u002FmL (both inclusive) for subject who is treated with 5-alpha reductase inhibitors (e.g., dutasteride, finasteride)\n  5. HbA1c ≤ 9 %\n  6. ALT ≤ 2.5 x ULN\n  7. AST ≤ 2.5 x ULN\n  8. Serum bilirubin ≤ 2.0 mg\u002FdL\n* No history of addiction to any recreational drug or drug dependence or alcohol abuse (including illicit steroid use) as per Investigator's judgement.\n* Subject is not considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug.\n* Subject is not currently enrolled in another clinical study and will not enroll in another clinical study throughout the duration of the study.\n\nExclusion Criteria:\n\n* Subjects with known hypersensitivity to study drug, including androgens, or product excipients.\n* Subjects with abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score \\> 19 points.\n* Subjects with history of, or current or suspected, prostate or breast cancer.\n* Subjects with history of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study enrollment except for diabetes, or renal disease\n* Subject with history of fluid or electrolyte imbalance.\n* Subject taking anticoagulant.\n* Subjects with history of uncontrolled heart failure, stroke or myocardial infarction within the past 6 months.\n* Subject with history of severe lower urinary tract symptoms in past 6 months.\n* Subjects with history of diagnosed, severe, untreated, obstructive sleep apnea.\n* Subjects working night shifts.\n* Subjects performing strenuous manual labor or exercise while wearing the ABPM monitor.\n* Subjects with chronic atrial fibrillation or any other chronic condition, which interferes with the ability to obtain precise ambulatory recordings.\n* Subject with polycythemia.\n* Subject with history of thrombophilia or venous thromboembolic events.\n* Subject with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).\n* Participation in any clinical study within 45 days or 5 half-lives of the drug before dosing of Investigational Product.\n* Loss of ≥ 350 ml (1 unit) of blood within 30 days of enrollment in the study.\n* Any other medical condition or serious inter current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study.","MALE","18 Years","75 Years",{"count":62,"type":21},144,[24],"A Phase 4, multi-center, open-label, single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) study of Testosterone Cypionate Injection in Hypogonadal Men to assess change in 24-hour ambulatory blood pressure from Baseline to End of Treatment",[66],"Hypogonadism, Male",[68,69],"Hypogonadal Men","Ambulatory Blood Pressure Monitoring (ABPM)","2026-01-07",{"date":72,"type":43},"2026-01-09",{"date":74,"type":21},"2026-02",{"date":76,"type":21},"2027-08",{"name":49,"class":50},6,""]