Reflex Epilepsy, Photosensitive Clinical Trial
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
| Verified date | February 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
PF-06372865 in subjects with photosensitive epilepsy
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | February 7, 2017 |
| Est. primary completion date | January 10, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins University Department of Neurology | Baltimore | Maryland |
| United States | Consultants in Epilepsy & Neurology, PLLC | Boise | Idaho |
| United States | General Clinical Research Center (GCRC) | Nashville | Tennessee |
| United States | Vanderbilt University Epilepsy Clinic | Nashville | Tennessee |
| United States | Vanderbilt University Hospital Pharmacy | Nashville | Tennessee |
| United States | VU Department of Neurology | Nashville | Tennessee |
| United States | New York University Comprehensive Epilepsy Center | New York | New York |
| United States | Clinical and Translational Research Center | Philadelphia | Pennsylvania |
| United States | Hospital of the Univ of PA Pharmacy Service | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Comprehensive Epilepsy Center | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital EEG lab | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Investigational Drug Service | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Barnes Jewish Hospital | Saint Louis | Missouri |
| United States | Center for Advanced Medicine | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The primary outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose. | Pre-dose, 1, 2, 4 and 6 hours post-dose | |
| Secondary | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose. | Pre-dose, 1, 2, 4 and 6 hours post-dose | |
| Secondary | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Complete suppression: SPR = 0 in all three eye conditions at the same time point. Partial response: A reduction in SPR of at least 3 units from baseline for at least 3 time points, and no time points with at least 3 units of increase, in the most sensitive eye condition; without meeting the complete suppression definition. No response: Did not meet complete suppression or partial response definitions. | Pre-dose, 1, 2, 4 and 6 hours post-dose | |
| Secondary | Maximum Plasma Concentration (Cmax) of PF-06372865 | 1, 2, 4 and 6 hours post-dose | ||
| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 | Pre-dose, 1, 2, 3, 4 and 6 hours post-dose | ||
| Secondary | Time for Cmax (Tmax) of PF-06372865 | 1, 2, 4 and 6 hours post-dose | ||
| Secondary | Plasma Concentration of Lorazepam | 1, 2, 3, 4 and 6 hours post-dose | ||
| Secondary | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests. | 17 weeks | |
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | 17 weeks | ||
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | 17 weeks | ||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs) | The all causalities treatment-emergent AEs by System Organ Class and Preferred Term in >5% of subjects. AEs included serious AEs and non-serious AEs. | 19 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04076410 -
Efficacy of Lenses in Abolishing Photoparoxysmal Responses
|
N/A |