title: One-year safety and tolerability profile of pridopidine in patients with Huntington disease.
abstract: 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.
  
  
  CONCLUSIONS
  Pridopidine (≤90 mg/day) has an acceptable safety profile and is well-tolerated for 1 year.
  
  
  METHODS
  This study provides Class IV evidence that pridopidine (≤90 mg/day) is generally safe and well-tolerated in patients with Huntington disease for up to 1 year.
authors: Centre for Neurogenetics and Rare Diseases, IRCCS Neuromed, Pozzilli, Italy. squitieri@neuromed.it
authors: Ferdinando
authors: F
authors: Squitieri
authors: Bernhard
authors: B
authors: Landwehrmeyer
authors: Ralf
authors: R
authors: Reilmann
authors: Anne
authors: A
authors: Rosser
authors: Justo Garcia
authors: JG
authors: de Yebenes
authors: Allan
authors: A
authors: Prang
authors: Jelena
authors: J
authors: Ivkovic
authors: Jeremy
authors: J
authors: Bright
authors: Asa
authors: A
authors: Rembratt
mesh_terms: D000328:Adult; D003863:Depression / Q000139:chemically induced / Q000175:diagnosis; D004244:Dizziness / Q000139:chemically induced / Q000175:diagnosis; D005260:Female; D006801:Humans; D006816:Huntington Disease / Q000188:drug therapy* / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010880:Piperidines; C483720:pridopidine