CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
ATYR1940drug
Likely dose
ATYR1940 concentrate for solution for infusion (specific dose not stated)AI-extracted
Key inclusion· 4
  • ✓Enrolled in and completed the treatment period in the parent study.
  • ✓Demonstrated acceptable tolerability of ATYR1940 in the parent study.
  • ✓Showed acceptable compliance with ATYR1940 and study procedures in the parent study and willing to comply with current study procedures.
  • ✓Considered by Investigator and Sponsor to be a suitable candidate for continued ATYR1940 treatment.
Key exclusion· 7
  • ✕Expected to require curcumin or systemic albuterol during study (intermittent inhaled albuterol permitted).
  • ✕Chronic use of muscle-growth or activity-enhancing products (e.g., IGF, growth hormone, Coenzyme Q, Coenzyme A, creatine, L-carnitine).
  • ✕Statin treatment initiation or significant adjustment to statin regimen (stable chronic use is permitted).
  • ✕Planned vaccination during study participation.

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

Search/NCT02836418
NCT02836418Phase 2Completed
CompareCT.gov

An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Patients With Limb Girdle and Facioscapulohumeral Muscular Dystrophy

aTyr Pharma, Inc.·interventional·Posted Jul 19, 2016·Updated Dec 22, 2023

In Brief

A Phase 2 clinical trial evaluating ATYR1940 for Facioscapulohumeral Muscular Dystrophy and Limb Girdle Muscular Dystrophy. Completed, enrolled 8 participants across 5 sites in 3 countries.

Detailed Summary

ATYR1940-C-006 is a multi-national, multicenter study being conducted at centers in the United States (US) and Europe who participated in Study ATYR1940-C-003 (Stage 1 only) or Study ATYR1940-C-004 (that is, the parent studies).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacioscapulohumeral Muscular Dystrophy, Limb Girdle Muscular Dystrophy
CountriesDenmark, Italy, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 19, 2016
Enrollment StartJul 13, 2016
Primary CompletionApr 18, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.0 years ago

Interventions

ATYR1940drug

Concentrate for solution for infusion