Varenicline for Gait and Balance Impairment in Parkinson Disease

Summary

The purpose of this study is to determine if varenicline is effective in improving gait and balance impairment in patients with Parkinson disease.

Timeline

Start

2010-12-28

Primary completion

2018-11-02

Completion

2018-11-02

Outcome

Missed primary endpoint

registry analysis (other test); Varenicline vs Sugar Pill; p = 0.05; Cohen's d 0.15 (95% CI -4.01 to 4.61); Repeated measures analysis or variance NCT01341080 ↗

Publications

• Background Bohnen NI, Muller ML, Koeppe RA, Studenski SA, Kilbourn MA, Frey KA, Albin RL. History of falls in Parkinson disease is associated with reduced cholinergic activity. Neurology. 2009 Nov 17;73(20):1670-6. doi: 10.1212/WNL.0b013e3181c1ded6.
• Background Qutubuddin AA, Pegg PO, Cifu DX, Brown R, McNamee S, Carne W. Validating the Berg Balance Scale for patients with Parkinson's disease: a key to rehabilitation evaluation. Arch Phys Med Rehabil. 2005 Apr;86(4):789-92. doi: 10.1016/j.apmr.2004.11.005.
• Background Zesiewicz TA, Sullivan KL. Treatment of ataxia and imbalance with varenicline (chantix): report of 2 patients with spinocerebellar ataxia (types 3 and 14). Clin Neuropharmacol. 2008 Nov-Dec;31(6):363-5. doi: 10.1097/WNF.0b013e31818736a9.
• Background Perez XA, Quik M. Focus on alpha4beta2* and alpha6beta2* nAChRs for Parkinson's Disease Therapeutics. Mol Cell Pharmacol. 2011;3(1):1-6.
• Background Bohnen NI, Albin RL. The cholinergic system and Parkinson disease. Behav Brain Res. 2011 Aug 10;221(2):564-73. doi: 10.1016/j.bbr.2009.12.048. Epub 2010 Jan 7.
• Background Karachi C, Grabli D, Bernard FA, Tande D, Wattiez N, Belaid H, Bardinet E, Prigent A, Nothacker HP, Hunot S, Hartmann A, Lehericy S, Hirsch EC, Francois C. Cholinergic mesencephalic neurons are involved in gait and postural disorders in Parkinson disease. J Clin Invest. 2010 Aug;120(8):2745-54. doi: 10.1172/JCI42642. Epub 2010 Jul 12.

Drugs

Indications