[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Afasci Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,77],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100566020","phase-2-safety-and-efficacy-study-on-afa-281-for-the-treatment-of-low-back-pain-100566020",false,"NCT06649747","Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain","A Double-blind, Placebo-controlled, Multi-center Phase II Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral AFA-281 in Patients With Painful Lumbosacral Radiculopathy","Inclusion Criteria:\n\n1. Signed informed consent form (ICF) indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, potential benefits, side effects, risks, and discomforts\n2. Men or nonpregnant, non-breastfeeding women 18 to 65 years of age who can read and understand written and spoken local language\n3. Clinical diagnosis of CLBP due to LSR in a dermatomal pattern (L4, L5, or S1) that has been present for at least 3 months at the time of screening.\n4. MRI imaging is done within 12 months before screening that does not provide evidence of exclusionary pathology (see exclusion criteria). CT is acceptable for subjects with contra-indications for MRI.\n5. Willing to discontinue current pain medications from 2 weeks before randomization until the end of the clinical study (treatment).\n6. Numeric rating scale (NRS) ≥4 and ≤9 at screening based on the Patient's Global Impression of Severity (PGI-S)\n\nExclusion Criteria:\n\n1. Neuropathic pain due to other causes rather than LSR (e.g. painful diabetic neuropathy, other neuropathy, spinal abscess, infection, hematoma or malignancy; phantom limb pain)\n2. Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination\n3. History of surgical intervention for LSR at the radicular level of the current pain episode.\n4. Current indication for neurosurgery (e.g. progressive motor loss due to compression) or planned surgical intervention for LSR within the duration of the study\n5. Has planned surgical intervention for PLSR within the duration of the study. (Subjects with persistent radicular pain after prior surgery are eligible.)\n6. Spinal stenosis with neurogenic claudication (pain present during walking and signs of significant lumbar stenosis on existing MRI or CT scan)\n7. Presence of spinal cord stimulator.\n8. Hypersensitivity\u002Fallergic reaction to other T-type calcium agents, such as (but not limited to) ethosuximide, zonisamide, and the mixed sodium and T-type calcium channel blocker lamotrigine and .\n9. Patients who failed a relatively adequate treatment with a tricyclic antidepressants (TAC), selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs)\n10. Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to:\n\n    1. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening\n    2. New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled hypertension\n    3. Clinically significant electrocardiographic (ECG) abnormality per the investigator assessment\n    4. Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders","ALL","18 Years","70 Years",{"count":20,"type":21},408,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate if the drug candidate AFA-281 works to treat chronic low back and leg pain caused by painful lumbosacral radiculopathy (PLSR) in adults. This trial will also evaluate the safety of AFA-281. The main questions it aims to answer are:\n\n* Does AFA-281 mitigate pain?\n* What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 works to treat chronic low back and leg pain.\n\nParticipants will:\n\n* Take drug AFA-281 or a placebo three times every day for 4 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of their pain scores and about mood and sleep questionnaires, and the number of times they use a rescue pain medicines.",[27],"Lumbosacral Radiculopathy",[29,30,31,32,33,34],"Analgesics","Inflammatory pain","Neurologic Diseases","Neuromuscular Diseases","Neuropathic pain,","Peripheral Nervous System Diseases","NOT_YET_RECRUITING","2025-06-21",{"date":38,"type":39},"2025-06-26","ACTUAL",{"date":41,"type":21},"2027-04-01",{"date":43,"type":21},"2032-03-31",{"name":45,"class":46},"Afasci Inc","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100571411","phase-1-a-phase-i-study-of-the-interaction-of-alcohol-with-oral-afa-281-in-healthy-volunteers-100571411","NCT06719908","A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers","A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers","Inclusion Criteria:\n\n* Adults between 21 and 55 years of age, inclusive.\n* Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n* Currently consumes alcohol regularly (defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least one occasion in the 30 days prior to screening) but does not meet the DSM-5 criteria for Alcohol Use Disorder. Note: one standard alcoholic drink is equivalent to 1.5 oz. hard liquor or 5 oz. wine or 12 oz. beer.\n* Body mass index (BMI) within the range of 18.5 to 30.0 kg\u002Fm2, inclusive.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) at the screening visit\n* Adequate venous access\n* Must be surgically sterile (vasectomy, tubal ligation or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., condom) from the start of screening until study completion, and agree to refrain from donating sperm, for 90 days after study drug administration.\n* Agree to abstain from strenuous exercise during the inpatient stay of the study.\n\nExclusion Criteria:\n\n* History of significant sensitivity to any drug.\n* Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) \\> 430 msec.\n* Has an estimated creatinine clearance (CrCl) outside of normal range.\n* History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.\n* History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.\n* Requirement for any over-the-counter and\u002For prescription medication, vitamins and\u002For herbal supplements on a regular basis.\n* Use of any medications, vitamins and\u002For herbal supplements within the 2-week period prior to study drug administration.\n* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.\n* Display any latent signs of alcohol withdrawal per the Clinical Institute Withdrawal of Alcohol Assessment-Revised (CIWA-AR).\n* History or current diagnosis of a substance use disorder.\n* Positive urine drug screen for drugs of abuse at Screening or Day -1.\n* Consumption of alcohol within the 1-day period prior to study drug administration.\n* Receipt of any drug by injection within 30 days prior to study drug administration.\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.\n* History of cardiac disease, including family history of long-QT syndrome, second degree heart block Type II, third degree heart block or unexplained sudden deaths in their family.\n* Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.\n* Pregnant or nursing women\n* Receipt of any investigational product within 6 weeks prior to study drug administration.\n* Consumption of grapefruit or grapefruit products from 3 days prior to study drug administration.\n* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.\n* Current enrollment in another clinical study.\n* Previous enrollment in this study.\n* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive AFA-281.",true,"21 Years","55 Years",{"count":58,"type":21},20,[60],"PHASE1","The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol.\n\nParticipants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.",[63,64],"Alcohol","Alcohol Use Disorders",[66,63,67,68],"AFA-281","Ethanol","Healthy Volunteer","2024-12-02",{"date":71,"type":39},"2024-12-06",{"date":73,"type":21},"2025-07-01",{"date":75,"type":21},"2029-09-01",{"name":45,"class":46},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100570683","phase-2-a-study-of-the-safety-and-exploratory-efficacy-of-oral-afa-281-in-patients-with-alcohol-use-disorder-100570683","NCT06710431","A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder","A Double-blind, Placebo-controlled, Phase IIA Human Laboratory Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder","Inclusion Criteria:\n\n1. Age between 21 and 65\n2. Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n3. Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for moderate or severe AUD\n4. Report drinking at least 28 drinks per week if male, 21 drinks per week if female, in the 28 days prior to consent.\n5. Must be surgically sterile (vasectomy, tubal ligation, or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., condom) from the start of screening until study completion, and agree to refrain from donating sperm for 90 days after study drug administration.\n\nExclusion Criteria:\n\n1. Current treatment for alcohol use or a history of treatment in the 30 days before enrollment or treatment seeking\n2. Current (last 12 months) DSM-5 diagnosis of dependence on any psychoactive substances other than nicotine\n3. Current DSM-5 diagnosis of substance use disorder for any substance other than alcohol and nicotine\n4. Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder\n5. Current DSM-5 major depressive disorder with suicidal ideation\n6. Positive urine screen for narcotics, amphetamines, or sedative hypnotics\n7. Clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised\n8. Pregnancy, nursing, or refusal to use reliable method of birth control if female\n9. History of significant sensitivity to any drug.\n10. Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) \\> 430 ms.\n11. History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic or psychiatric disease or disorder, or any uncontrolled medical illness.\n12. Has an estimated creatinine clearance (CrCl) outside of normal range.\n13. History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.\n14. History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.\n15. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.\n16. Liver enzymes AST, ALT, or GGT ≥ 3 times upper normal limit.\n17. Positive urine drug screen for drugs of abuse at Screening or Day -1.\n18. Receipt of any drug by injection within 30 days prior to study drug administration.\n19. A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.\n20. Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.\n21. Pregnant or nursing women.\n22. Receipt of any investigational products within 6 weeks prior to study drug administration.\n23. Current enrollment in another clinical study.\n24. Previous enrollment in this study.\n25. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to participate in the AFA-281 Phase I1a Study.","65 Years",{"count":86,"type":21},36,[24],"This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain thresholds, anxiety, depression, and sleep.",[90,91,92,93,94,95],"Alcohol Abuse","Alcohol Abuse\u002Faddiction","Anxiety","Pain Threshold","Depression Disorders","Sleep Disorder",[66,97,98,99,100,101,102],"alcohol abuse","alcohol","depression","pain threshold","sleep disorder","anxiety","2024-11-26",{"date":105,"type":39},"2024-11-29",{"date":107,"type":21},"2025-10-01",{"date":109,"type":21},"2027-12-01",{"name":45,"class":46},1,""]