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Randomized placebo-controlled study of the nicotinic agonist SIB-1508Y in Parkinson disease

Address correspondence and reprint requests to Dr. Karen A. Blindauer, Department of Neurology, Medical College of Wisconsin, 9200 W. Wisconsin Ave., Milwaukee, WI 53226; e-mail: kblindau{at}mcw.edu

This randomized, placebo-controlled, 5-week Phase II trial evaluated the safety and tolerability of SIB-1508Y, a selective 4ß2 nicotinic acetylcholine receptor agonist, in 77 individuals with early Parkinson disease. Lightheadedness was a common dosage-related adverse effect at higher dosages, leading to frequent dosage reduction, drug discontinuation, and eventual trial redesign. A maximally tolerated dosage of 10 mg daily was identified. No antiparkinsonian or cognitive-enhancing effects were demonstrated in this trial.

Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the February 14 issue to find the title link for this article.

* See Appendix for a complete listing of the Parkinson Study Group authors.

Sponsor: Sibia Neurosciences, Inc. (currently part of Merck & Co., Inc.).

Disclosure: In keeping with the Parkinson Study Group conflict of interest guidelines, none of the investigators have any personal financial relationship with the sponsor. All compensation received by investigators for trial-related services was paid through a contract between the University of Rochester and the sponsor that was established before the trial began.

Received November 19, 2002. Accepted in final form October 10, 2005.