Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide … (NCT02976038) | Clinical Trial Compass
TerminatedPhase 2
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
Stopped: Registration trial did not meet the primary end points
United States28 participantsStarted 2016-12
Plain-language summary
This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial
Who can participate
Age range16 Years
SexALL
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Inclusion Criteria:
* Investigator determines the subject can, and subject agrees to, adhere to the trial requirements for the length of the trial including self-administration (by subject or trained caregiver) of the study drug
* Subject completed the End-of-Study Visit in SPIMM-202
Exclusion Criteria:
* Subject has any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all trial requirements
* Subject has received any investigational compound (excluding elamipretide) and/or has participated in another interventional clinical trial within 30 days prior to the SPIMM-203 Baseline Visit (excluding SPIMM-202) or is concurrently enrolled in any non-interventional research of any type judged to be scientifically or medically incompatible with the trial as deemed by the Investigator in consultation with the Sponsor
* Subject experienced an adverse reaction attributed to study drug resulting in permanent discontinuation of study drug in the SPIMM-202 trial.
* Female subjects who are pregnant, planning to become pregnant, or lactating
* Subject has undergone an in-patient hospitalization within the 1 month prior to the SPIMM-203 Baseline Visit
What they're measuring
1
Distance Walked on Six Minute Walk Test
Timeframe: Baseline, Month 3, Month 6 and Every 26 weeks for up to 160 weeks