Phase 2
Completed N=7
PF-06372865 in Subjects With Photosensitive Epilepsy
Reflex Epilepsy, Photosensitive
Source: ClinicalTrials.gov NCT02564029 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition — 0.57; 1.38; 1.58; 6.80 Units on a scale
Summary
PF-06372865 in subjects with photosensitive epilepsy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition |
0.57; 1.38; 1.58; 6.80 | — |
| SECONDARY The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition |
0.57; 1.38; 1.58; 6.80; 0.33; 0.40 | — |
| SECONDARY The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) |
85.7; 85.7; 85.7; 28.6; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of PF-06372865 |
81.30; 200.6 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 |
331.3; 771.4 | — |
| SECONDARY Time for Cmax (Tmax) of PF-06372865 |
2.12; 3.02 | — |
| SECONDARY Plasma Concentration of Lorazepam |
7.38; 13.32; 17.10; 17.87; 15.93 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Test Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (AEs) |
4; 6; 6; 5; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02564029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.