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.

CONCLUSION:

Pridopidine (≤90 mg/day) has an acceptable safety profile and is well-tolerated for 1 year.

CLASSIFICATION OF EVIDENCE:

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: Ferdinando Squitieri, Bernhard Landwehrmeyer, Ralf Reilmann, Anne Rosser, Justo Garcia de Yebenes, Allan Prang, Jelena Ivkovic, Jeremy Bright, Asa Rembratt
• Journal: Neurology (Neurology) Vol. 80 Issue 12 Pg. 1086-94 (Mar 19 2013) ISSN: 1526-632X [Electronic] United States
• PMID: 23446684 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Piperidines
• pridopidine

Topics

• Adult
• Depression (chemically induced, diagnosis)
• Dizziness (chemically induced, diagnosis)
• Female
• Humans
• Huntington Disease (drug therapy, epidemiology)
• Male
• Middle Aged
• Piperidines (adverse effects, therapeutic use)
• Time Factors
• Treatment Outcome