Clinical trial NCT02564029: PF-06372865 in Subjects With Photosensitive Epilepsy
Official title: A Double Blind, Randomized, Cross- Over Study Examining Efficacy Of Pf-06372865 In A Photosensitivity Epilepsy Study Using Lorazepam As A Positive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reflex Epilepsy, Photosensitive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-09-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: PF-06372865 in subjects with photosensitive epilepsy


Eligibility criteria: Inclusion Criteria:

* A diagnosis and history of photoparoxysmal response on electroencephalogram (EEG) with or without a diagnosis of epilepsy for which subjects are taking up to 0 - 2 concomitant antiepileptic drugs.
* Subjects currently taking antiepileptic drug(s) to be on a stable dose for 4 weeks prior to Screening Visit.
* A minimum average standardized photosensitive range (SPR) across all screening timepoints of 4 in the most sensitive eye condition and a non-zero average in at least one other eye condition.

Exclusion Criteria:

* Subjects with a history of status epilepticus.
* Subjects who have experienced a generalized tonic-clonic convulsion in the past 6 months, at the time of the initial screening visit.

Primary outcomes:
measure: The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
timeFrame: Pre-dose, 1, 2, 4 and 6 hours post-dose
Secondary outcomes:
measure: The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
timeFrame: Pre-dose, 1, 2, 4 and 6 hours post-dose
measure: The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)
timeFrame: Pre-dose, 1, 2, 4 and 6 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of PF-06372865
timeFrame: 1, 2, 4 and 6 hours post-dose
measure: Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
timeFrame: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose
measure: Time for Cmax (Tmax) of PF-06372865
timeFrame: 1, 2, 4 and 6 hours post-dose
measure: Plasma Concentration of Lorazepam
timeFrame: 1, 2, 3, 4 and 6 hours post-dose
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities
timeFrame: 17 weeks
measure: Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
timeFrame: 17 weeks
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
timeFrame: 17 weeks
measure: Number of Participants With Treatment-emergent Adverse Events (AEs)
timeFrame: 19 weeks
Other outcomes:
Locations:
city: Boise
country: United States
facility: Consultants in Epilepsy & Neurology, PLLC
state: Idaho
city: Baltimore
country: United States
facility: Johns Hopkins University Department of Neurology
state: Maryland
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: New York University Comprehensive Epilepsy Center
state: New York
city: Philadelphia
country: United States
facility: Clinical and Translational Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the Univ of PA Pharmacy Service
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Comprehensive Epilepsy Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital EEG lab
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Investigational Drug Service
state: Pennsylvania
city: Nashville
country: United States
facility: General Clinical Research Center (GCRC)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Epilepsy Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Hospital Pharmacy
state: Tennessee
city: Nashville
country: United States
facility: VU Department of Neurology
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.