Session Information
Date: Thursday, June 23, 2016
Session Title: Other
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To understand the effects of nelotanserin on objective sleep parameters in a phase 2 study in patients with primary insomnia.
Background: Nelotanserin is a highly potent and selective 5HT2A inverse agonist. Effects on sleep parameters in a Phase 2 study in patients with primary insomnia were evaluated to confirm CNS penetration and assess target engagement across doses.
Methods: A randomized, double-blind, placebo controlled, three-way cross-over study in patients with primary insomnia was conducted. Patients received nelotanserin doses of 10mg and 40mg, or placebo at bedtime. Treatment duration was 7 days with a washout period of 7-9 days between treatments. Objective sleep parameters were assessed by polysomnography (PSG).
Results: Nelotanserin produced statistically significant improvements in parameters of sleep maintenance and sleep consolidation. P-values reported in the table below are pair-wise comparisons of nelotanserin to placebo.
| Wake after sleep onset (mins) | Number of arousals | Number of awakenings | Wake during sleep (mins) | |
| Placebo (n = 157) | -46.0 | 2.5 | -1.5 | -38.5 |
| 10 mg nelotanserin (n = 158) | -54.3 | -4.5 | -2.3 | -48.5 |
| p = 0.013 | p < 0.001 | p < 0.001 | p < 0.001 | |
| 40 mg nelotanserin (n = 158) | -49.8 | -7.0 | -2.3 | -45.8 |
| p = 0.199 | p < 0.001 | p < 0.001 | p < 0.001 |
Conclusions: Nelotanserin produced statistically significant effects on objective sleep parameters with doses as low as 10 mg daily. These data indicate that nelotanserin reaches the target receptors in the CNS at clinically relevant doses, and supports its development in patients with Dementia with Lewy Bodies, a disorder commonly associated with serious sleep disturbances.
Previously presented in December 2015 at the 1st Annual International DLB Conference.
To cite this abstract in AMA style:
W. Wen, L. Friedhoff, K. Kishnani, S. Ramaswamy, M. Sanchez, W. Shanahan. Effect of nelotanserin on objective sleep parameters in a phase 2 study in patients with insomnia [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/effect-of-nelotanserin-on-objective-sleep-parameters-in-a-phase-2-study-in-patients-with-insomnia/. Accessed June 14, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-nelotanserin-on-objective-sleep-parameters-in-a-phase-2-study-in-patients-with-insomnia/