Study Details

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A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

Terminated/Withdrawn
The study has stopped early and will not start again. Participants were not enrolled (for withdrawn studies), however if participants were enrolled, they are no longer being examined or treated.

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

Follow Trial

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 - 65 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

34

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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Akron Children’s Hospital

Akron, United States, 44308

University of Texas Health Science Center at Hosuton

Houston, United States, 77030

Columbia University Irving Medical Center

New York, United States, 10032

Massachusetts General Hospital

Boston, United States, 02114

Mayo Clinic

Rochester, United States, 55905

Baylor College of Medicine

Houston, United States, 77030

Cleveland Clinic

Cleveland, United States, 44195

Stanford University Medical Center

Stanford, United States, 94305

Mayo Clinic Arizona

Phoenix, United States, 85054

Mayo Clinic Florida

Jacksonville, United States, 32224

Children’s Hospital Colorado

Aurora, United States, 80045

Seattle Children's Hospital

Seattle, United States, 98105

University of California, San Diego

La Jolla, United States, 92093

Children's Hospital of Philadelphia

Philadelphia, United States, 19104

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