PF-06372865 in Subjects With Photosensitive Epilepsy

Summary

PF-06372865 in subjects with photosensitive epilepsy

Timeline

Start

2015-12-16

Primary completion

2017-01-10

Completion

2017-02-07

Outcome

Met primary endpoint

registry PF-06372865 17.5 mg vs Placebo; Mean Difference (Final Values) -6.23 (90% CI -8.60 to -3.86) NCT02564029 ↗

registry PF-06372865 52.5 mg vs Placebo; Mean Difference (Final Values) -5.42 (90% CI -7.78 to -3.06) NCT02564029 ↗

paper Both doses of PF-06372865 produced a marked and statistically significant mean reduction in SPR compared to placebo PMID 30877186 ↗

Publications

• Gurrell R, Gorman D, Whitlock M, Ogden A, Reynolds DS, DiVentura B, Abou-Khalil B, Gelfand M, Pollard J, Hogan RE, Krauss G, Sperling M, Vazquez B, Wechsler RT, Friedman D, Butt RP, French J. Photosensitive epilepsy: Robust clinical efficacy of a selective GABA potentiator. Neurology. 2019 Apr 9;92(15):e1786-e1795. doi: 10.1212/WNL.0000000000007271. Epub 2019 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darigabat	Small molecule	17.5 mg	—
Subject	Darigabat	Small molecule	52.5 mg	—
Comparator	Lorazepam	Small molecule	2 mg	Oral

Indications