CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
ERX-963 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03959189
NCT03959189Phase 1Completed
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Double-Blind, Placebo-Controlled, Dose-Range-Finding, Crossover Trial of Single Day Administration of ERX-963 in Adults With Myotonic Dystrophy Type 1

Expansion Therapeutics, Inc.·interventional·Posted May 22, 2019·Updated Jun 23, 2021

In Brief

A Phase 1 clinical trial evaluating ERX-963 and Placebo for Myotonic Dystrophy, Type 1 (DM1) and Myotonic Dystrophy. Completed, enrolled 12 participants across 4 sites.

Detailed Summary

Participants in this study will receive two treatments, placebo and ERX-963, on different days in a randomized fashion. The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in participants diagnosed with Myotonic Dystrophy, Type 1 (DM1). The secondary purpose is to evaluate the potential of ERX-963 treatment to reduce excessive daytime sleepiness / hypersomnia and improve cognitive function in DM1 participants compared to placebo treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyotonic Dystrophy, Type 1 (DM1), Myotonic Dystrophy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMay 22, 2019
Enrollment StartJun 17, 2019
Primary CompletionMar 31, 2020
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.1 years ago

Interventions

ERX-963drug

Active medicine

Placebodrug

Comparator