A Phase 3 interventional study of Metformin and Placebo in Huntington Disease, sponsored by Instituto de Investigacion Sanitaria La Fe. Completed at 9 sites in Spain. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Phase 3, Interventional, and Treatment
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).
Multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of treatment with metformin at a dose of 1700 mg / day in adults with HD.
A total recruitment of 60 patients is expected, which will be randomized in a 1: 1 ratio. 30 patients will receive metformin 1700 g / day, or placebo, for 52 weeks.
Patients will begin taking low doses of metformin, to facilitate tolerance and decrease intestinal discomfort. Half the daily dose (425 mg twice daily) will be administered over four weeks, along with the main meals. Patients who tolerate this dose well will continue with treatment by taking 850mg twice daily. Patients who don´t tolerate the initial dose (425 mg twice daily) will be withdrawn from the study.
285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 203 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Therapeutic group: Biguanidines (antidiabetic) Administration way: Oral Initial dose: 425 mg twice daily Maximum dose: 850 mg, twice daily Treatment duration: 12 months
Drug: Metformin
Therapeutic group: NA Administration way: Oral Initial dose: 425 mg twice daily Maximum dose: 850 mg, twice daily Treatment duration: 12 months
Drug: Placebo
Metformin oral: 425 mg twice daily (initial dose) and 850 twice daily (maximum dose)
Also known as: Biguanides (oral antidiabetic)
425 mg twice daily (initial dose) and 850 twice daily (maximum dose)
Also known as: Not appicable
Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale
The tests that make up this subscale are the Symbol Digit Modalities Test. It is a comparative test that is collected throughout the entire trial to assess the progression of cognitive functions in patients. The test has 90 seconds time limit.
Time frame: Baseline - Week 52
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 tests that make up this subscale are the verbal fluency under phonetic slogan with the letters F, A and S, It is a comparative test that is collected throughout the entire trial to assess the progression of cognitive functions in patients. It consists of four categories of time 0-15; 16-30; 31-45 and 46-60 seconds and both hits and errors are counted.
Time frame: Baseline - Week 52
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 tests that make up this subscale are words and interference in the Stroop test. The Stroop test was performed to determine selective attention and inhibitory response (selective response to stimuli) to recognize a different stimulus among others. The test involves three kinds of stimuli: three columns of color names printed in black (condition A), three columns with different colors (red, green, blue or black) (condition B), and three columns of color names printed in a color that does not necessarily correspond to the word (for For example, the word "green" printed in blue, (condition C). The 3 parts of the test consist of A. speed of reading the words (names of colors printed in black), B. speed of nomination, the subject must name the colors. C. inhibitory response, called the interference test, where the subject must name the color in which the word with the name of the other color. The test has 45 seconds time limit.
Time frame: Baseline - Week 52
Evaluate the effect of metformin on motor function in patients with Huntington's disease using the Unified Huntington's Disease Scale Total Motor Score.
The motor function evaluation will include the following exams: Ocular Pursuit (horizontal and vertical), Saccade Initiation (horizontal and vertical), Saccade Velocity (horizontal and vertical), Dystrary, Lingual Protusion, Distonia (trunk and limbs), Korea (face , Mouth, trunk and extremities), Repulsion Test, Finger Tast (right and left), Pronate/ Supinate-Hands (right and left), Luria (palm test), Arm rigidity (right and left), Brady Kinesia-Body, Gait (walking difficulties), Tandem Walking. The initial stage of Huntington's Disease is related to a score greater than 4 on the Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) and a total functional capacity (UHDRS-TFC) greater than 8.
Time frame: Baseline - Visit 1 (Week 0) - Week 26 - Week 52
Evaluate the effect of metformin on functional capacity in patients with Huntington´s disease using Unified Huntington's Disease Scale Functional Capacity.
It is evaluated by means of a questionnaire on the following variables: Occupation, Finance, Daily life activities, Domestic Works Level of Care. The initial stage of Huntington's Disease is related to a score greater than 4 on the Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) and a total functional capacity (UHDRS-TFC) greater than 8. Where 0 its de worse situation and 3 its normal situation
Time frame: Baseline - Visit 1 (Week 0) - Week 26 - Week 52
Evaluate the effect of metformin on behavioral signs and symptoms in patients with Huntington´s disease using Problem Behaviors Assessment-Short form (PBA-s)
Specifically, will be evaluated on the changes in severity obtained in the items of depressed mood, suicidal ideation, anxiety, irritability, aggressiveness, apathy, persistent behavior and thinking, obsessive-compulsive behavior, delusional ideation, hallucinations, and disorientation. The severity is scored is the 0 (absent) to 4 (severe; almost unbearable for the caregiver) The frequency is scored is the 0 (never / almost never) to 4 (daily / almost daily most of the day)
Time frame: Baseline - Visit 1 (Week 0) - Week 26 - Week 52
Evaluate if there are genetic markers associated to metformin by analysis pharmacogenetic.
Analyze whether there are genetic markers associated with a better (or worse) response to metformin, through pharmacogenetics. The genotype of the patients will be analyzed on this material in a panel of single nucleotide polymorphisms (SNPs), related to the effect of Metformin and other medications that patients may be taking simultaneously.
Time frame: Visit 1 (week 0)
Analyze the light chain protein of neurofilaments in peripheral blood.
Analyze the light chain protein of neurofilaments in peripheral blood, as a circulating biomarker. Biomarker analysis will consist of obtaining information on the concentrations of various proteins, which tend to be released into the bloodstream when there are lesions in the nervous system.
Time frame: Visit 1 (week 0) and Visit 8 (Week 56)
Evaluate the effect of metformin on the degree of independence in patients with Huntington's disease using the Unified Huntington's Disease Rating Scale Functional assessment and independence assessment.
The scale consists in two parts. The first part is to make a functional evaluation with scored is 0 or 1. The second part evaluate degree of independence with scored the 5% to 100%.
Time frame: Baseline - Visit 1 (Week 0) - Week 26 - Week 52
Evaluate the effect of metformin in patients body with Huntington's disease.
Incidence of adverse events and incidence of abnormal laboratory test results, The classification of adverse events will be mild, moderate and serious by medical criteria.
Time frame: Baseline to Week 52
Plan to share: No
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Instituto de Investigacion Sanitaria La Fe