Trial · NCT05267574
An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead)
NCT05267574, Phase 2, Phase 3, Terminated, Reneo Pharma Ltd; results first posted 2024-05-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead). Trials, record NCT05267574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05267574
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead)
- NCT number
- NCT05267574
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 155 participants, actual
- Lead sponsor
- Reneo Pharma Ltd
- Conditions
- Primary Mitochondrial Myopathy
- Interventions
- REN001
- First posted
- 2022-03-04
- Last updated
- 2024-05-28
- Results first posted
- 2024-05-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Mild, Moderate, Severe TEAEs, TEAEs Leading to Study Discontinuation, All TEAEs and All TESAEs | Baseline through study termination, an average of 12.1 months | Number of participants with AEs and severity |
| Secondary | Absolute Values, Changes From Baseline, and Incidence of Potentially Clinically Significant Changes in Laboratory Safety Tests, Electrocardiograms, Supine Vital Signs, and Eye Assessments | Study Termination | Number of participants |
| Secondary | Change in Distance Walked During a 12 Minute Walk Test | Baseline to Month 24 | Distance walked in meters |
| Secondary | Change in Modified Fatigue Impact Scale (MFIS) Score | Baseline to Month 24 | The MFIS is a 21-item scale to describe the impact of fatigue on physical, cognitive, and psychosocial functioning. The questionnaire includes 9 physical, 10 cognitive, and 2 psychosocial items with each item scored between 0=Never and 4=Almost Always |
| Secondary | Change in Patient Global Impression of Severity (PGIS) Score | Baseline to Month 24 | The PGIS is a 2-item questionnaire to describe the severity of fatigue and muscle symptoms. Each item is scored as Absent, Mild, Moderate, Severe, or Very Severe |
| Secondary | Change in Brief Pain Inventory (BPI) Score | Baseline to Month 24 | The BPI is a 15-item questionnaire to describe severity of pain and its interference on functioning. The questionnaire includes 4 pain severity items each scored between 0=No Pain and 10= Pain, and 7 pain interference items each scored between 0=Does not Interfere and 10=Completely Interferes |
| Secondary | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Short Form - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue 13a Scores | Baseline to Month 24 | The PROMIS Short Form - FACIT Fatigue 13a is a 13-item questionnaire to describe fatigue and its impact upon daily activities and function. Each item is scored between 1=Not At All and 5=Very Much |
| Secondary | Change in 36-Item Short Form Health Survey (SF-36) Score | Baseline to Month 24 | The SF-36 is a 36-item questionnaire to describe health status and quality of life. The questionnaire includes 8 domains (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions). Items are scored, summed into domains, and transformed into a scale of 0-100 |
| Secondary | Change Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Score | Baseline to Month 24 | The WPAI:SHP is a 6-item questionnaire to describe impairment in work and activities due to a certain disease. Items are scored, summed, and transformed into a scale of 0-100% |
| Secondary | Change in Patient Global Impression of Change (PGIC) Score | Baseline to Month 24 | The PGIC is a 2-item questionnaire to describe the change in fatigue and muscle symptoms since starting the study. Each item is scored as Very Much Worse, Moderately Worse, Minimally Worse, No Change, Minimally Improved, Moderately Improved, or Very Much Improved |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Mild, Moderate, Severe TEAEs, TEAEs Leading to Study Discontinuation, All TEAEs and All TESAEs | Baseline through study termination, an average of 12.1 months | participants | NUMBER | |
| SECONDARY | Absolute Values, Changes From Baseline, and Incidence of Potentially Clinically Significant Changes in Laboratory Safety Tests, Electrocardiograms, Supine Vital Signs, and Eye Assessments | Study Termination | |||
| SECONDARY | Change in Distance Walked During a 12 Minute Walk Test | Baseline to Month 24 | |||
| SECONDARY | Change in Modified Fatigue Impact Scale (MFIS) Score | Baseline to Month 24 | |||
| SECONDARY | Change in Patient Global Impression of Severity (PGIS) Score | Baseline to Month 24 | |||
| SECONDARY | Change in Brief Pain Inventory (BPI) Score | Baseline to Month 24 | |||
| SECONDARY | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Short Form - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue 13a Scores | Baseline to Month 24 | |||
| SECONDARY | Change in 36-Item Short Form Health Survey (SF-36) Score | Baseline to Month 24 | |||
| SECONDARY | Change Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Score | Baseline to Month 24 | |||
| SECONDARY | Change in Patient Global Impression of Change (PGIC) Score | Baseline to Month 24 |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Mild, Moderate, Severe TEAEs, TEAEs Leading to Study Discontinuation, All TEAEs and All TESAEs | REN001 | Mild TEAEs | 68 | participants | |
| Number of Participants With Mild, Moderate, Severe TEAEs, TEAEs Leading to Study Discontinuation, All TEAEs and All TESAEs | REN001 | Moderate TEAEs | 50 | participants | |
| Number of Participants With Mild, Moderate, Severe TEAEs, TEAEs Leading to Study Discontinuation, All TEAEs and All TESAEs | REN001 | Severe TEAEs | 5 | participants | |
| Number of Participants With Mild, Moderate, Severe TEAEs, TEAEs Leading to Study Discontinuation, All TEAEs and All TESAEs | REN001 | TEAEs leading to study drug discontinuation | 1 | participants | |
| Number of Participants With Mild, Moderate, Severe TEAEs, TEAEs Leading to Study Discontinuation, All TEAEs and All TESAEs | REN001 | Total TEAEs | 123 | participants | |
| Number of Participants With Mild, Moderate, Severe TEAEs, TEAEs Leading to Study Discontinuation, All TEAEs and All TESAEs | REN001 | Total TESAEs | 12 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | REN001 | 155 | |
| Overall Study | COMPLETED | REN001 | 0 | |
| Overall Study | NOT COMPLETED | REN001 | 155 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | REN001 | 25 | 155 | |
| other | Upper respiratory tract | Infections and infestations | REN001 | 10 | 155 | |
| other | Influenza | Infections and infestations | REN001 | 9 | 155 | |
| other | Constipation | Gastrointestinal disorders | REN001 | 8 | 155 | |
| other | Fatigue | General disorders | REN001 | 12 | 155 | |
| other | Headache | Nervous system disorders | REN001 | 17 | 155 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | REN001 | 12 | 155 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | REN001 | 9 | 155 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | REN001 | 8 | 155 | |
| other | Vitamin D deficiency | Metabolism and nutrition disorders | REN001 | 8 | 155 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | REN001 | 0 | 155 |
| Total, other adverse events | REN001 | 123 | 155 |
| Total, serious adverse events | REN001 | 12 | 155 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05267574
GET https://conductscience.org/api/trials/v1/NCT05267574/events?page=2