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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.
GLOSSARY
- AE=
- adverse event;
- HD=
- Huntington disease;
- OLE=
- open-label extension;
- RCT=
- randomized controlled trial;
- SAE=
- serious adverse event;
- UHDRS-TMS=
- Unified Huntington's Disease Rating Scale Total Motor Score
Footnotes
Coinvestigators are listed on the Neurology® Web site at www.neurology.org.
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Supplemental data at www.neurology.org
- Received July 30, 2012.
- Accepted December 12, 2012.
- © 2013 American Academy of Neurology
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