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A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly (MOTION)

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ClinicalTrials.gov Identifier: NCT02245620
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

Brief Summary:
This study will be a Phase 2, randomized, double-blind, placebo-controlled study, enrolling 40 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether the administration of MTP-131 will change either hand skeletal muscle energetics or muscle performance in age-related skeletal muscle mitochondrial dysfunction.

Condition or disease Intervention/treatment Phase
Skeletal Muscle Mitochondrial Dysfunction in the Elderly Drug: MTP-131 (Bendavia™) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Impact of a Single Intravenous Dose of MTP-131 (Bendavia™) on Skeletal Muscle Function in the Elderly
Study Start Date : February 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: MTP-131 (Bendavia™) Drug: MTP-131 (Bendavia™)
MTP-131 (Bendavia™; 0.25 mg/kg/hour) administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours

Placebo Comparator: Placebo Drug: Placebo
Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
Other Name: elamipretide




Primary Outcome Measures :
  1. Mean change in ATPmax (Maximal ATP synthetic rate) [ Time Frame: From Baseline to Hour 2 (2 hours after the start of infusion or end of infusion) ]
    Maximal ATP synthetic rate (phosphorylation capacity per unit muscle volume) is determined by a muscle fatigue test.


Secondary Outcome Measures :
  1. Mean change in P/O (Phosphate/Oxygen ratio) [ Time Frame: From Baseline at Hour 2 (2 hours after the start of infusion or end of infusion) and Day 7 ]
  2. Mean change in Nicotine adenine dinucleotide (NAD) [ Time Frame: From Baseline at Hour 2 (2 hours after the start of infusion or end of infusion) and Day 7 ]
  3. Mean change in Muscle force-time-integral [ Time Frame: From Baseline at Day 3 ]
    Mean change from Baseline between treatment groups with respect to muscle performance measured as muscle work rate and maximum integrated force generated will be calculated from the results of the hand muscle fatigue test.



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are male and female adults aged ≥60 and ≤85 years
  2. Female subjects must be post-menopausal
  3. Have in vivo 31P MRS (Magnetic Resonance Spectroscopy) and OPS (Optical Spectra Scan) determined ATPmax (Maximal ATP synthetic rate) < 0.70 mM/sec
  4. Have in vivo 31P MRS (Magnetic Resonance Spectroscopy) and OPS (Optical Spectra Scan) determined P/O (Phosphate/Oxygen ratio) < 1.9
  5. Are ambulatory and able to perform activities of daily living without assistance

Exclusion Criteria:

  1. Have significant disease(s) or condition(s) which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
  2. Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g. myocardial infarction, target-vessel revascularization, coronary bypass surgery or stroke) or other major medical condition (as deemed by the primary investigator)
  3. Have any metal implants that cannot be removed from the body that in the opinion of the investigator are a contra-indication for undergoing the MRS procedure or any other protocol-related procedure)
  4. Have an implanted cardiac pacemaker or other implanted cardiac device
  5. Have chronic, uncontrolled hypertension as judged by the Investigator
  6. Have a BMI of < 16 or > 32 kg/m2
  7. Have a creatinine clearance < 45 mL/min as calculated by the Cockcroft-Gault equation
  8. Subject's right hand has history of mobility impairment, fractures, arthritis, hand surgery, muscle disease or other injury that may interfere with any study procedure

    • Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245620


Locations
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United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Stealth BioTherapeutics Inc.

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Responsible Party: Stealth BioTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT02245620     History of Changes
Other Study ID Numbers: SPITM-201
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017

Keywords provided by Stealth BioTherapeutics Inc.:
Skeletal muscle dysfunction, MTP-131, Bendavia™
elamipretide