Trials / Completed
CompletedNCT02460679
Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2A Safety and Biomarker Study of EPI-589 in Subjects With Amyotrophic Lateral Sclerosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- PTC Therapeutics · Industry
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label study with 30-day run in phase to establish baseline parameters, 90-day treatment phase, and a 90-day withdrawal phase to determine long-term effects, duration of treatment response, and potential effects of EPI-589 therapy on known trajectory.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EPI-589 | An immediate release film-coated table at a 250 mg dosage strength will be administered per dose and schedule specified in arm. |
Timeline
- Start date
- 2016-01-14
- Primary completion
- 2018-02-23
- Completion
- 2018-02-23
- First posted
- 2015-06-02
- Last updated
- 2020-10-14
- Results posted
- 2020-09-23
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02460679. Inclusion in this directory is not an endorsement.