9 completed, 1 withdrawn. 10 Phase 1, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 9, Withdrawn 1 |
| Phase 2 | 3 | Completed 2, Withdrawn 1 |
Follow Zonisamide: new trials by email Literature Review of Zonisamide trials Research Report on Zonisamide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Prevention of Noise-induced Hearing Loss Zonisamide, Methylprednisolone - Noise-induced Hearing Loss | Phase 1 / Phase 2 | Withdrawn | Washington University School of Medicine | 2017-10-31 | 2017-11-06 | |
| Characterization of Epilepsy Patients BEEP 2b Oxcarbazepine (brand name vs generic drugs), Divalproex Sodium (brand name vs generic drugs), Carbamazepine (brand name vs generic drugs) - Epilepsy | Phase 1 | Completed | Food and Drug Administration (FDA) | 21 | 2017-06-08 | 2020-03-27 |
| Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation zonisamide, placebo - Nicotine Dependence | Phase 1 / Phase 2 | Completed | Johns Hopkins University | 74 | 2012-09-01 | 2018-01-24 |
| Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse Zonisamide, Placebo, Cocaine Hydrochloride - Cocaine Dependence | Phase 1 / Phase 2 | Completed | Johns Hopkins University | 19 | 2010-06-01 | 2017-09-05 |
| Fasting Bioavailability Study of Zonisamide Capsules Zonisamide 100 mg Capsule, Zonisamide (Zonegran®) 100 mg Capsule - Healthy | Phase 1 | Completed | Mutual Pharmaceutical Company, Inc. | 34 | 2005-01-01 | 2010-01-26 |
| Fed Bioavailability Study of Zonisamide Capsules Zonisamide 100 mg Capsule, Zonisamide (Zonegran®) 100 mg Capsule - Healthy | Phase 1 | Completed | Mutual Pharmaceutical Company, Inc. | 34 | 2005-01-01 | 2010-01-26 |
| Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions Zonisamide, Zonegran - Healthy | Phase 1 | Completed | Dr. Reddy's Laboratories Limited | 26 | 2005-01-01 | 2010-07-14 |
| Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions Zonisamide, Zonegran - Healthy | Phase 1 | Completed | Dr. Reddy's Laboratories Limited | 26 | 2005-01-01 | 2010-07-14 |
| Fed Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg Zonisamide Capsules 100 mg, Zonegran® Capsules 100 mg - Healthy | Phase 1 | Completed | Mylan Pharmaceuticals Inc | 110 | 2003-12-01 | 2024-04-23 |
| Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg Zonisamide Capsules 100 mg, Zonegran® Capsules 100 mg - Healthy | Phase 1 | Completed | Mylan Pharmaceuticals Inc | 107 | 2003-11-01 | 2024-04-23 |
Behavior, Addictive (1) · Cocaine-Related Disorders (1) · Epilepsy (1) · Hearing Loss (1) · Hearing Loss, Noise-Induced (1) · Smoking Cessation (1) · Substance-Related Disorders (1) · Tobacco Use Disorder (1)
Dr. Reddy's Laboratories Limited (2) · Johns Hopkins University (2) · Mutual Pharmaceutical Company, Inc. (2) · Mylan Pharmaceuticals Inc (2) · Food and Drug Administration (FDA) (1) · Washington University School of Medicine (1)
United States (9)
Annie Umbricht, M.D. (2) · Antonio R Pizarro, M.D (2) · Dorian Williams, M.D. (2) · James D Carlson, Pharm.D. (1) · James E Polli, Ph.D (1) · Judith Lieu, MD (1)
R01DA027065 (1), R21DA034164 (1)