At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
Metformindrug
Likely dose
Metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Heart Rate Variability in Response to Metformin Challenge
In Brief
A Phase 2 clinical trial evaluating Metformin for Fibromyalgia and 3 related conditions. Completed, enrolled 61 participants across 1 site.
Detailed Summary
Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then provide an additional sample 2 hours later.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedJul 2015
Primary CompletionFeb 2016
TodayJul 2026
First PostedJul 16, 2015
Enrollment StartJul 1, 2015
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.0 years ago
Interventions
Metformindrug
500 mg orally after baseline testing of heart rate