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A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

This trial is recruiting
The study is currently recruiting participants.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT04641962

Astellas Study ID

The unique identification code given by the study sponsor.

0367-CL-1201

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

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Condition

Primary Mitochondrial Myopathy (PMM)

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 Years - 54 Years

Sex

Female & Male

Product

ASP0367

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

May 2021 - May 2024

Masking

Triple (Participant, Care Provider, Investigator)

Enrollment number

195

A Randomized, Double-blind, Placebo-controlled Adaptive Phase 2/3 Study with Open-label Extension to Assess the Efficacy, Safety and Tolerability of ASP0367 in Participants with Primary Mitochondrial Myopathy

Study summary

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Locations

Akron Children’s Hospital

Akron, United States, 44308

Recruiting
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University of Texas Health Science Center at Hosuton

Houston, United States, 77030

Recruiting
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Columbia University Irving Medical Center

New York, United States, 10032

Recruiting
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Massachusetts General Hospital

Boston, United States, 02114

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Mayo Clinic

Rochester, United States, 55905

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Baylor College of Medicine

Houston, United States, 77030

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Cleveland Clinic

Cleveland, United States, 44195

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Stanford University Medical Center

Stanford, United States, 94305

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Mayo Clinic Arizona

Phoenix, United States, 85054

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Mayo Clinic Florida

Jacksonville, United States, 32224

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Children’s Hospital Colorado

Aurora, United States, 80045

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Seattle Children's Hospital

Seattle, United States, 98105

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University of California, San Diego

La Jolla, United States, 92093

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Children's Hospital of Philadelphia

Philadelphia, United States, 19104

Recruiting
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