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One-year safety and tolerability profile of pridopidine in patients with Huntington disease


Squitieri, Ferdinando, Landwehrmeyer, Bernhard, Reilmann, Ralf, Rosser, Anne, de Yebenes, Justo Garcia, Prang, Allan, Ivkovic, Jelena, Bright, Jeremy, Rembratt, Åsa


Neurology, Volume: 80, No.: 12, Pages.: 1086-1094

Year of Publication



Objective: To assess the 1-year safety profile of the dopaminergic stabilizer pridopidine in patients with Huntington disease. Methods: Patients received pridopidine 45 mg/day for 4 weeks then pridopidine 90 mg/day for 22 weeks in this 6-month open-label extension (OLE) of the 6-month MermaiHD randomized controlled trial (RCT). Any adverse events (AEs) were recorded. Patients were categorized by their RCT treatment group (placebo, pridopidine 45 mg/day, pridopidine 90 mg/day). Results: Of the 386 patients who completed the RCT, 353 entered the OLE and 305 (86.4%) completed. In 1 year, similar percentages of patients from each group reported ≥ 1 AE (placebo, 79.6% [n = 90/113]; 45 mg/day, 80.8% [n = 101/125]; 90 mg/day, 82.6% [n = 95/115]) and ≥ 1 serious AE (8.0% [n = 9/113], 12.8% [n= 16/125], and 8.7% [n = 10/115], respectively). The AE profile across both studies was similar; falls and worsening of chorea were most commonly reported. During the OLE, more patients previously receiving pridopidine reported ≥ 1 AE (67.9% [n = 163/240]) than those who had received placebo (56.6% [n = 64/113]). Early in the RCT, small increases in heart rate were reported in patients receiving pridopidine. During 1 year, no clinically meaningful changes in laboratory parameters or EKG-related safety concerns were identified. Conclusion: Pridopidine (≤ 90 mg/day) has an acceptable safety profile and is well-tolerated for 1 year. (PsycINFO Database Record (c) 2013 APA, all rights reserved). (journal abstract)


adverse, dopamine, dopaminergic stabilizer, drug safety, drug therapy, effects, huntington disease, huntingtons disease, pridopidine, safety, tolerability

Countries of Study


Types of Dementia


Types of Study

Randomised Controlled Trial

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Pharmaceutical Interventions

Pharmaceutical Interventions