Randomized placebo-controlled study of the nicotinic agonist SIB-1508Y in Parkinson disease.
This randomized, placebo-controlled, 5-week Phase II trial evaluated the safety and tolerability of SIB-1508Y, a selective alpha4beta2 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.
D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D004244:Dizziness / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000188:drug therapy*; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011759:Pyrrolidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D018722:Nicotinic Agonists; D011725:Pyridines; D011759:Pyrrolidines; C100989:altinicline maleate