12 completed, 1 terminated, 1 unknown. 7 Phase 1, 5 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 7 |
| Phase 2 | 5 | Completed 4, Unknown 1 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma Dexpramipexole, Placebo - Eosinophilic Asthma, Asthma | Phase 2 | Completed | Knopp Biosciences | 534 | 2019-08-15 | 2023-04-13 |
| Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia dexpramipexole - Chronic Sinusitis With Nasal Polyps and Eosinophilia | Phase 2 | Completed | Knopp Biosciences | 20 | 2014-08-01 | 2021-05-18 |
| Study to Evaluate Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome Dexpramipexole - Hypereosinophilic Syndrome | Phase 2 | Unknown | National Institute of Allergy and Infectious Diseases (NIAID) | 15 | 2014-03-14 | 2017-12-07 |
| Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects Dexpramipexole - Healthy Volunteers | Phase 1 | Completed | Knopp Biosciences | 24 | 2012-06-01 | 2014-11-25 |
| Phase 3 Extension Study of Dexpramipexole in ALS Dexpramipexole - Amyotrophic Lateral Sclerosis | Phase 3 | Terminated | Knopp Biosciences | 616 | 2012-06-01 | 2022-05-03 |
| Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study Warfarin, Dexpramipexole - Healthy Volunteers | Phase 1 | Completed | Knopp Biosciences | 15 | 2012-05-01 | 2014-11-25 |
| Dexpramipexole and Cimetidine Drug Drug Interaction (DDI) Dexpramipexole, Cimetidine plus Dexpramipexole - Amyotrophic Lateral Sclerosis | Phase 1 | Completed | Knopp Biosciences | 14 | 2012-03-01 | 2014-11-25 |
| Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate) Dexpramipexole, Dexpramipexole Placebo, Moxifloxacin - Amyotrophic Lateral Sclerosis | Phase 1 | Completed | Knopp Biosciences | 68 | 2012-01-01 | 2014-11-25 |
| Dexpramipexole SAD/MAD Study Dexpramipexole, Dexpramipexole Placebo - Amyotrophic Lateral Sclerosis | Phase 1 | Completed | Knopp Biosciences | 63 | 2011-11-01 | 2014-11-25 |
| Dexpramipexole Japanese PK Study Single dose reduced, Single dose standard, Multiple Dose - Amyotrophic Lateral Sclerosis | Phase 1 | Completed | Knopp Biosciences | 57 | 2011-08-01 | 2021-06-22 |
| Dexpramipexole Renal PK Study Dexpramipexole (dose 1), Dexpramipexole (dose 2) - Amyotrophic Lateral Sclerosis, Renal Insufficiency | Phase 1 | Completed | Knopp Biosciences | 36 | 2011-07-01 | 2014-11-25 |
| Phase 3 Study of Dexpramipexole in ALS Dexpramipexole, Placebo - Amyotrophic Lateral Sclerosis | Phase 3 | Completed | Knopp Biosciences | 942 | 2011-03-01 | 2021-06-07 |
| Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211) KNS-760704 - Amyotrophic Lateral Sclerosis | Phase 2 | Completed | Knopp Biosciences | 74 | 2009-07-01 | 2021-08-16 |
| Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) Placebo, Dexpramipexole 50 mg/day, Dexpramipexole 150 mg/day - Amyotrophic Lateral Sclerosis | Phase 2 | Completed | Knopp Biosciences | 194 | 2008-04-09 | 2021-07-08 |
Amyotrophic Lateral Sclerosis (9) · Motor Neuron Disease (4) · Asthma (2) · Eosinophilia (2) · Nervous System Diseases (2) · Hypereosinophilic Syndrome (1) · Nasal Polyps (1) · Pulmonary Eosinophilia (1) · Renal Insufficiency (1) · Rhinosinusitis (1) · Sinusitis (1)
Dexpramipexole (13) · Cimetidine (1) · Moxifloxacin (1) · Warfarin (1)
United States (13) · United Kingdom (3) · Australia (2) · Belgium (2) · Canada (2) · France (2) · Germany (2) · Ireland (2) · Netherlands (2) · Spain (2) · Sweden (2)
Amy D Klion, M.D. (1) · Merit Cudkowicz, M.D., MSc (1) · Merit Cudkowicz, MD, MSc (1) · Michael Bozik, MD (1)