TEsting METformin Against Cognitive Decline in HD (NCT04826692) | Clinical Trial Compass
CompletedPhase 3
TEsting METformin Against Cognitive Decline in HD
Spain60 participantsStarted 2022-04-11
Plain-language summary
Multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of metformin treatment at a dose of 1700 mg / day in adults with Huntington's disease.
The study consists of a screening period (2 to 4 weeks), followed by a 52-week double-blind treatment period and a follow-up visit (one month after the end of treatment).
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. Symptomatic positive clinical diagnosis of Huntington disease.
✓. Presence of 36 CAG repeats (or more) in the hunting gene based on centralized CAG analysis.
✓. Men or women between 21-65 years of age, inclusive, with an onset of HD at 18 years of age or older.
✓. Women of childbearing potential (women who are not postmenopausal children or who have not undergone surgical sterilization at times) will need to be using a contraceptive method for 30 days before beginning study treatment, and will have contact with at least two methods of birth control throughout the duration of the study and up to 30 days after taking the last dose of treatment.
✓. A sum of \> 4 points on the UHDRS-TMS scale and a diagnostic confidence level of 4.
✓. Scale of independence ≥ 75%.
✓. Score on the UHDRS-TFC scale ≥ 8 at the screening visit.
✓. They must be trained and willing to provide written informed consent prior to any procedure related to the study to be performed at the screening visit. Patients with a legal guardian must be determined according to local requirements.
Exclusion criteria
✕. The participant has taken metformin in the last three months before the start of the study.
✕. The participant has diabetes of any kind.
✕. The participant is pregnant or lactating.
What they're measuring
1
Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale
Timeframe: Baseline - Week 52
2
Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale (UHDRS).
Timeframe: Baseline - Week 52
3
Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale (UHDRS).
✕. The participant has a medical condition other than HD (metabolism, kidney function, liver function, heart problems, etc.), or any contraindication against metformin.
✕. The participant has an uncontrolled psychiatric condition.
✕. Participant is allergic to metformin or any of the other ingredients of this medicine.
✕. The participant has kidney problems \[creatinine clearance \<60 ml / min calculated using Cockcroft-Gault formula\] or liver problems.
✕. The participant is dehydrated, from prolonged or severe diarrhea, or has vomited several times.