Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Completed · Phase 2
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT02460679
- Run by
- PTC Therapeutics
- People needed
- 19
- Starts
- 2016-01-14
- Expected to finish
- 2018-02-23
- Last updated by the study team
- 2020-10-14
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of possible, probable, laboratory supported probable, or definite ALS by E1 Escorial Criteria
- Forced vital capacity (FVC) ≥ 70% of predicted
- Weakness onset within 3 years
- Agreement to use contraception if within reproductive years
- Willingness and ability to comply with study procedures
- Stable regimen of dietary supplements and /or riluzole for at least 30 days prior to enrollment
- Abstention from use of other investigative or non-approved drugs
- Participants must be able to swallow 0.375 * 0.700 inch tablets
You may not qualify if…
- Allergy to EPI-589
- Use of ventilation
- Participation in other intervention studies
- Diagnosis of any other neurologic disease
- Malignancy within the past 2 years
- History of stroke
- History of brain surgery
- Hepatic insufficiency with liver function tests (LFTs) greater than 3 times upper limit of normal (ULN)
- Renal insufficiency requiring dialysis
- End stage cardiac failure
- Participation in a trial of a device, drug, or other therapy for ALS within 3 months of screening or during the trial
Where it is running
- Cedar's Sinai — Los Angeles, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- Providence Brain and Spine Institute ALS Center — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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