Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)

ClinicalTrials.gov ID: NCT02460679

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Official title

A Phase 2A Safety and Biomarker Study of EPI-589 in Subjects With Amyotrophic Lateral Sclerosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02460679
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: PTC Therapeutics; Industry
Enrollment: 19 participants

Conditions and interventions

Conditions

Amyotrophic Lateral Sclerosis

Interventions

EPI-589 Drug

Drug

Eligibility (public fields only)

Age range: 21 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 14, 2016 (Actual)
Primary completion: Feb 23, 2018 (Actual)
Completion: Feb 23, 2018 (Actual)
Last update posted: Oct 14, 2020

2016 – 2018

United States locations

U.S. sites: 3
U.S. states: 2
U.S. cities: 3

Facility	City	State	ZIP	Site status
Cedar's Sinai	Los Angeles	California	90048	—
California Pacific Medical Center	San Francisco	California	94115	—
Providence Brain and Spine Institute ALS Center	Portland	Oregon	97213	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02460679, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 14, 2020 · Synced Nov 15, 2026