NCT03862846

TerminatedPhase 1

A Study of the Safety of REN001 in Patients With Primary Mit...

Reneo Pharma Ltd Source

Reneo Pharma Ltd

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

REN001-101

Study Type

interventional

Actual enrollment (reported)

23

Locations

1 country

Sites

2

Timeline

Study Start

May 10, 2019

Actual (reported)

Primary Completion

April 23, 2020

Actual (reported)

Study Completion

April 23, 2020

Actual (reported)

Brief Summary

The purpose of this study is to assess REN001 safety in subjects with primary mitochondrial myopathy

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 23 participants
Study completion date: April 23, 2020
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 28, 2019
Actual (reported)
First Posted
March 5, 2019
Actual (reported)
Study Start
May 10, 2019
Actual (reported)
Primary Completion
April 23, 2020
Actual (reported)
Study Completion
April 23, 2020
Actual (reported)

Last Updated: July 16, 2020
Status Verified: March 2020
Last Update Submitted: July 14, 2020

Conditions

Primary Mitochondrial Myopathy

Outcome Measures

Primary Outcomes (1)

Adverse Events
Number of participants with Adverse Events as a measure of safety and tolerability
Comparing Baseline to Week 12

Secondary Outcomes (1)

Adverse Events
Continous to Week 48

Study Arms (1)

Group

EXPERIMENTAL

REN001 Low Dose

Drug: REN001

Interventions

REN001Drug

Once daily

Group

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Subjects must give written, signed and dated informed consent
Confirmed diagnosis of PMM according to the 2016 Rome Consensus recommendations

Sponsors & Collaborators

Reneo Pharma Ltd
Industrylead

Study Sites (2)

Institute of Neurology, University College London

London, WC1N 3BG, United Kingdom

Wellcome Centre for Mitochondrial Research

Newcastle upon Tyne, NE2 4HH, United Kingdom

Study Officials

Grainne Gorman, MD
Wellcome Centre for Mitochondrial Research
PRINCIPAL INVESTIGATOR

Enrollment

23 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 5, 2019

Study Start

May 10, 2019

Actual (reported)

Primary Completion

NCT03323749

A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension

Phase 3Terminated

Confirmed mitochondrial mutation with evidence of myopathy

Able to remain on stable medication throughout the study

You may not qualify if:

Documented evidence of ongoing rhabdomyolysis
Subjects with motor abnormalities other than related to mitochondrial disease
Treatment with an investigational drug within 3 months prior to Day 1
Hospitalised within 3 months prior to screening for any major medical condition
Pregnant or nursing females

Contact the study team to confirm eligibility.

April 23, 2020

Actual (reported)

Study Completion

April 23, 2020

Actual (reported)

Last Updated

July 16, 2020

Record last verified: 2020-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03862846
Data provider: ClinicalTrials.gov
Source updated: 2020-07-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:45 UTC

Locations

GB(2)

Study Stopped

A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations