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Bocidelpar for Mitochondrial Myopathy (MOUNTAINSIDE Trial)
MOUNTAINSIDE Trial Summary
This trial is testing a new drug, ASP0367, to see if it is safe and effective at treating people with a certain disease. The trial is divided into two phases: phase 2 and phase 3. In phase 2, the researchers will test the drug to see what dose is biologically active and how it affects the body. In phase 3, the researchers will test the drug to see if it improves the symptoms of the disease.
MOUNTAINSIDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMOUNTAINSIDE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MOUNTAINSIDE Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with PMM and show symptoms or signs of muscle disease.I have certain heart, kidney, liver, mental health, behavior, thinking, or lung conditions.I've been taking the same dose of CoQ10 or similar supplements for 3 months and plan to continue.I am not pregnant and follow the required birth control guidelines.You have certain heart or vision problems, need a ventilator to breathe, or have severe and unstoppable seizures.I am not allergic to the study drug, don't have COVID-19 symptoms, and my weight is within the required range.I have other health issues that affect my walking or standing, not related to muscle disease.I agree to use contraception with my partner who can become pregnant.I have a history of infections, substance abuse, or specific medication use.I have had cancer or another type of malignancy in the past.I agree to follow the study's requirements, including tests and using apps.I have medical conditions or have had procedures that disqualify me from the study.I have weakness in my face or throat muscles due to nerve or muscle disease.
- Group 1: Phase 2: Low dose ASP0367
- Group 2: Phase 2: High dose ASP0367
- Group 3: Phase 2: Placebo
- Group 4: Phase 3: ASP0367
- Group 5: Phase 3: Placebo
- Group 6: Open Label Extension: ASP0367
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any specific medical requirements to become a test subject in this experiment?
"As this is a study for luft disease, only individuals aged 18-80 can be accepted as participants. Up to 195 people will be able to join the trial."
Does this experiment require participants to be over 30 years old?
"This clinical trial is specifically for patients aged 18-80. However, there are 9 other trials for minors and 30 studies involving seniors above the age of 65."
Can new patients still join this clinical trial?
"The trial is currently recruiting participants, with the most recent update on November 11th, 2022. The original posting was on May 17th, 2021. Across 14 locations, the study is looking for a total of 195 patients."
How many people can sign up for this experiment at most?
"One hundred and ninety-five patients that meet the inclusion criteria are needed for this clinical trial. Children's hospitals like Akron Children's Hospital in Ohio and Baylor College of Medicine in Texas are two examples of where patients can participate from."
What are the goals that this research study is aiming to achieve?
"According to the study sponsor, Astellas Pharma Inc, the primary objective of this study is to assess the number of participants with body weight change abnormalities and/or AEs over a Through Week 80 time frame. Additionally, this trial will also measure secondary outcomes including change from baseline in quality of life in neurological disorders (Neuro-QoL) Short Form Fatigue score, Patient Global Impression of Change (PGIC) score, and Neuro-QoL Short Form Lower Extremity Function (Mobility) score."
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