BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

Summary

This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with Parkinson's disease.

Timeline

Start

2017-11-10

Primary completion

2019-05-28

Completion

2019-05-28

Outcome

Missed primary endpoint

registry analysis (superiority test); BEN-2001, 0.5mg; p = 0.668; Mean Difference (Final Values) -0.30 (95% CI -1.68 to 1.08); ANCOVA NCT03194217 ↗

registry analysis (superiority test); BEN-2001, 1.0mg; p = 0.213; Mean Difference (Final Values) 0.88 (95% CI -0.50 to 2.26); ANCOVA NCT03194217 ↗

registry analysis (superiority test); BEN-2001, 3.0mg; p = 0.575; Mean Difference (Final Values) -0.39 (95% CI -1.76 to 0.98); ANCOVA NCT03194217 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bavisant	Small molecule	0.5 mg	Oral
Subject	bavisant	Small molecule	1 mg	Oral
Subject	bavisant	Small molecule	3 mg	Oral

Indications