- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02245620
A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly (MOTION)
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 Overview
Status
Intervention / Treatment
Detailed Description
This was a Phase 2, randomized, double-blind, placebo-controlled study, enrolling 41 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether the administration of MTP-131 (elamipretide) will change either hand skeletal muscle energetics or muscle performance in age-related skeletal muscle mitochondrial dysfunction.
Subjects were randomized 1:1 to receive either elamipretide at 0.25 mg/kg/hr intravenously at a rate of 60 mL/hr for 2 hours, or placebo (lyophilized excipients without elamipretide) intravenously at a rate of 60 mL/hr for 2 hours. Each treatment group went through three distinct periods: Screening (up to 28 days), Treatment (1day), and Observation (7 days).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- The University of Washington Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Are male and female adults aged ≥60 and ≤85 years
- Female subjects must be post-menopausal
- Have in vivo phosphorus-31 (31P) Magnetic Resonance Spectroscopy (MRS) and (Optical Spectra Scan (OPS) determined maximum adenosine triphosphate synthetic rate (ATPmax) < 0.70 milliMol/second (mM/sec)
- Have in vivo 31P MRS and OPS determined P/O (Phosphate/Oxygen ratio) < 1.9
- Are ambulatory and able to perform activities of daily living without assistance
- Had sufficient venous access for study drug administration and clinical testing.
- Could speak and read English fluently.
- Provided informed consent.
Exclusion Criteria:
- Had significant disease(s) or condition(s) which, in the opinion of the Investigator, may have put the subject at risk because of their participation in the study or may have influenced either the results of the study or the subject's ability to participate in the study.
- Had a history of rhabdomyolysis.
- Had 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).
- Had any metal implants that could not be removed from the body that in the opinion of the Investigator were a contra-indication for undergoing the MRS procedure or any other protocol-related procedure.
- Had an implanted cardiac pacemaker or other implanted cardiac device.
- Had a serum sodium level <136 milliequivalents per litre (mEq/L) at Screening or Pre-infusion.
- Had a hemoglobin level <12 g/dL at Screening or Pre-infusion.
- Had chronic, uncontrolled hypertension as judged by the Investigator (e.g., Baseline systolic blood pressure [SBP] >140 mm Hg, diastolic blood pressure [DBP] > 90 mm Hg) or a SBP >150 mm Hg or DBP >95 mm Hg at the time of Screening or Baseline (if the initial blood pressure [BP] reading was above these values, the reading may have been repeated one time within 20 minutes of the initial reading).
- Had a body mass index (BMI) of <16 or >35 kg/m2.
- Had a creatinine clearance <45 mL/min as calculated by the Cockcroft Gault equation.
- Had a 12-lead electrocardiogram (ECG) demonstrating severe bradycardia (heart rate < 40 bpm) or average corrected QC interval (QTc) >450 ms for males and > 470 ms for females, and in the opinion of the Investigator was clinically significant. (If on the initial ECG, QTc exceeded 450 ms for males or 470 ms for females, the ECG was to be repeated 2 more times and the average of the 3 QTc values was to be used to determine the subject's eligibility).
- Had a neurologic disorder that in the opinion of the Investigator was a contra-indication for enrollment into the study.
- Had any symptoms consistent with or a current diagnosis of peripheral neuropathy, such as numbness, tingling, pain, or altered sensation of hands or feet.
- Had an active, systemic autoimmune disease other than autoimmune thyroid disease (e.g., diabetes, lupus, rheumatoid arthritis) that currently required treatment or was likely to require treatment during the study.
- Subject's right hand had a history of mobility impairment, fractures, arthritis, hand surgery, muscle disease or other injury that may interfere with any study procedure.
- Had any symptoms consistent with or a current diagnosis of claustrophobia.
- Had a history of cancer, unless subject had documentation of completed curative treatment.
- Had a history of or risk factors (e.g., significant family history, concomitant medical condition) for deep vein thrombosis or pulmonary embolism.
- Had a history of serious mental illness as judged by the Investigator.
- Had a body temperature > 37.5°C at the time of planned dosing.
- Subjects who in the opinion of the Investigator abused alcohol or drugs.
- Had donated or received blood or blood products within the past 30 days.
- Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family was defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Sponsor employees and/or their immediate families. Immediate family was defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Were currently enrolled in a clinical study involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study.
- Had participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product had a long half-life, 3 months or 5 half-lives (whichever was longer) should have passed.
- Had previously been randomized into any study investigating elamipretide or been exposed to elamipretide for any reason.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elamipretide
Elamipretide given as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours.
|
Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours
Other Names:
|
Placebo Comparator: Placebo
Placebo (lyophilized excipients without elamipretide) given as an intravenous infusion at a rate of 60 mL/hr for 2 hours.
|
Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in ATPmax (Maximal ATP Synthetic Rate)
Time Frame: From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
|
Maximal ATP synthetic rate (phosphorylation capacity per unit muscle volume) as determined by a muscle fatigue test.
|
From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Phosphate/Oxygen (P/O) Ratio
Time Frame: From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
|
As a measure of mitochondrial hand skeletal muscle energetics, mitochondrial coupling, or Phosphate/Oxygen ratio (P/O) was assessed at Baseline, Day 1 Hour 2, and Day 7.
|
From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
|
Mean Change From Baseline in Nicotine Adenine Dinucleotide (NAD)
Time Frame: From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
|
From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
|
|
Mean Change From Baseline in Muscle Force-Time-Integral (FTI)
Time Frame: From Baseline to Day 1 Hour 2, Day 3, and Day 7
|
Muscle Force-Time-Integral was measured as mean change from baseline at Day 1 Hour 2, Day 3, and Day 7.
|
From Baseline to Day 1 Hour 2, Day 3, and Day 7
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SPITM-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skeletal Muscle Mitochondrial Dysfunction in the Elderly
-
University Hospital, Strasbourg, FranceCompletedSkeletal Muscle Ischemia | Severe Lower Limb Ischemia | Mitochondrial DysfunctionFrance
-
University of MichiganEnrolling by invitationCellular Responses Within Skeletal Muscle in Response to Exercise of Different Intensities | Relationship Between the Cellular Responses in Skeletal Muscle and the Changes in the Metabolomic Profile | Changes Within Adipose Tissue in Response to Exercise at the Three Different IntensitiesUnited States
-
Democritus University of ThraceCompletedSkeletal Muscle Performance | Skeletal Muscle Damage | Intgracellular Signaling in Skeletal Muscle | Inflammatory StatusGreece
-
University of ThessalyCompletedSkeletal Muscle Performance | Skeletal Muscle Damage | Exercise-induced Aseptic Inflammation | Intracellular Signaling in Skeletal Muscle | Proteasome ActivationGreece
-
Amazentis SAEurofins OptimedCompletedAging | Muscle Function | Mitochondrial DysfunctionFrance
-
Mayo ClinicRecruitingEffects of GAHT, on Skeletal Muscle in TGDUnited States
-
Bispebjerg HospitalCompletedSarcopenia | Skeletal Muscle Protein Synthesis in Elderly | Protein KineticsDenmark
-
University of CopenhagenCompleted
-
University Hospital, LilleRecruiting
-
University Hospital, LimogesUnknownDisablement in the ElderlyFrance
Clinical Trials on Elamipretide
-
Stealth BioTherapeutics Inc.CompletedAge-related Macular DegenerationUnited States
-
Stealth BioTherapeutics Inc.CompletedMitochondrial MyopathyUnited States
-
Stealth BioTherapeutics Inc.TerminatedPrimary Mitochondrial DiseaseUnited States
-
Stealth BioTherapeutics Inc.TerminatedPrimary Mitochondrial MyopathyUnited States, Germany, Canada, Italy, United Kingdom, Denmark, Hungary
-
Stealth BioTherapeutics Inc.CompletedHeart FailureNetherlands, Italy, United Kingdom
-
Stealth BioTherapeutics Inc.CompletedHeart FailureSpain, Hungary, Netherlands, United Kingdom, Serbia, France, Latvia, Belgium, Bulgaria, Poland
-
Stealth BioTherapeutics Inc.CompletedPrimary Mitochondrial DiseaseUnited States
-
Stealth BioTherapeutics Inc.Charite University, Berlin, Germany; SCIRENT Clinical Research and Science...Completed
-
Stealth BioTherapeutics Inc.AvailableMitochondrial Diseases | Barth Syndrome
-
Stealth BioTherapeutics Inc.CompletedAge-Related Macular DegenerationUnited States