← Back to Search

Fatty Acid Oxidation Inhibitor

Mavodelpar for Mitochondrial Myopathy (STRIDE Trial)

Phase 2
Waitlist Available
Led By Amel Karaa, MD
Research Sponsored by Reneo Pharma Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented PMM primarily characterized by exercise intolerance or active muscle pain.
Subjects age 18 years or older with PMM as defined by the International Workshop: Outcome measures and clinical trial readiness in primary mitochondrial myopathies in children and adult (Mancuso et al 2017).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights

STRIDE Trial Summary

This trial will test if a new drug, REN001, is effective and safe for treating PMM (a 24-week study).

Eligible Conditions
  • Primary Mitochondrial Myopathy

STRIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have muscle pain during exercise or when active.
Select...
You are 18 years or older and have a type of muscle disease called primary mitochondrial myopathy (PMM), as defined by a group of experts.

STRIDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in distance walked during a 12 Minute Walk Test
Secondary outcome measures
Change in PROMIS Short Form - Fatigue 13a (FACIT-fatigue) scores
Other outcome measures
Change Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) score
Change in 36-Item Short Form Health Survey (SF-36) score
Change in Brief Pain Inventory (BPI) score
+6 more

STRIDE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MavodelparExperimental Treatment1 Intervention
Once daily
Group II: Matched placeboPlacebo Group1 Intervention
Once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavodelpar
2021
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Reneo Pharma LtdLead Sponsor
5 Previous Clinical Trials
282 Total Patients Enrolled
Amel Karaa, MDPrincipal InvestigatorMassachusetts General Hospital (MGH)
4 Previous Clinical Trials
550 Total Patients Enrolled

Media Library

REN001 (Fatty Acid Oxidation Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04535609 — Phase 2
Mitochondrial Myopathy Research Study Groups: Mavodelpar, Matched placebo
Mitochondrial Myopathy Clinical Trial 2023: REN001 Highlights & Side Effects. Trial Name: NCT04535609 — Phase 2
REN001 (Fatty Acid Oxidation Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535609 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team currently enrolling new participants?

"Clinicaltrials.gov confirms that recruitment for this medical trial is still ongoing since it's initial posting on May 21st 2021 and subsequent editing in December 7th 2022."

Answered by AI

What is the geographic scope of this experiment?

"Patients can enrol in this study at several locations, including the University of Texas McGovern Medical School in Houston and UT South Western located in Dallas. Moreover, there are 13 other sites across Alberta and California that are also participating."

Answered by AI

Is this an innovative research project?

"Since 2021, REN001 has been studied by the pharmaceutical company known as Reneo Pharma Ltd. The initial study in 2021 featured 200 participants and concluded with successful Phase 2 approval of the medication. Currently, only one active clinical trial involving this drug is being run by Reneo Pharma Ltd."

Answered by AI

How many participants are included in this clinical experiment?

"The clinical trial necessitates 200 participants that comply with the outlined inclusion criteria. Those hoping to volunteer can do so from University of Texas McGovern Medical School in Houston, and UT South Western in Dallas, Alberta."

Answered by AI

Could you elaborate on the research that has been done with REN001 in prior experiments?

"The REN001 medication was first explored in 2021 at A.O.U Policlinico di Messina U.O.C Neurologia e Malattie Neuromuscolari, and since then a total of 18352 clinical trials were completed with 1 still recruiting patients presently - primarily based out of Houston, Texas."

Answered by AI

What risks does REN001 pose to human health?

"With Phase 2 scientific evidence suggesting safety, REN001 has been assigned a score of 2 on our risk assessment scale. Nevertheless, there is no corresponding data that verifies its efficacy."

Answered by AI
~56 spots leftby Mar 2025