Metformin for Motor and Cognitive Improvement in Children With Cerebral Palsy: A Feasibility Study (NCT03710343) | Clinical Trial Compass
CompletedPhase 2
Metformin for Motor and Cognitive Improvement in Children With Cerebral Palsy: A Feasibility Study
Canada3 participantsStarted 2023-11-14
Plain-language summary
The study design is a single-subject ABA clinical trial that is investigating the feasibility including adherence, safety and tolerability of metformin in children aged 5 to 18 years with cerebral palsy (CP). ABA refers to Phase A1 with no metformin, Phase B with metformin, and Phase A2 with no metformin. Secondarily, the study is exploring whether metformin has possible health benefits for improving motor function and cognition.
Who can participate
Age range5 Years – 18 Years
SexALL
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Inclusion criteria
✓. Physician diagnosis of cerebral palsy defined "as a group of permanent disorders of the development of movement and posture causing activity limitation that is attributed to non-progressive disturbances that occurred in the developing fetal or infant brain."
✓. Evidence of WMI or GMI pattern on prior clinical neuro-imaging scanning (MRI)
✓. No history of hypoglycemia after 2 years of age
✓. No aspiration pneumonias in the last year requiring hospitalization
✓. No lower extremity orthopedic surgery in the last six months prior to trial entry
✓. No acute or chronic metabolic acidosis and/or lactic acidosis over the lifespan, including a lactate level greater than 2.4 mmol/L at the screening visit.
✓. No history of renal disease
✓. Age 5 to 18 years, 11 months at the time of enrollment
Exclusion criteria
✕. No prior clinically ordered neuro-imaging to allow determination of WMI or GMI
✕. Have a known hypersensitivity to metformin hydrochloride or any of the excipients
✕. Have Diabetes (Type I or II)
✕. Have taken oral metformin previously
✕
What they're measuring
1
The first indicator of feasibility will be assessed
Timeframe: 1.25 years
2
The second indicator of feasibility will be assessed
Timeframe: 1.25 years
3
The third indicator of feasibility will be assessed
Timeframe: 1.25 years
4
The fourth indicator of feasibility will be assessed
. Have been part of another clinical intervention study within the past 3 months prior to study entry
✕. Require sedation for blood tests
✕. Treatment or planned treatment involving diuretics
✕. Current or planned treatment with cationic drugs excreted by the kidneys (e.g. amiloride, cimetidine, digoxin, morphine, nifedipine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin).