PF-06372865 in Subjects With Photosensitive Epilepsy

Pfizer

Status and phase: Completed; Phase 2

Conditions: Reflex Epilepsy, Photosensitive

Treatments: Drug: Placebo; Drug: PF-06372865; Drug: Lorazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02564029

B7431005

Details and patient eligibility

About

PF-06372865 in subjects with photosensitive epilepsy

Enrollment: 7 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

7 participants in 4 patient groups, including a placebo group

PF-06372865 dose level 1

Experimental group

Description:

17.5 milligram (mg) single dose

Treatment:

Drug: PF-06372865

PF-06372865 dose level 2

Experimental group

Description:

52.5 mg single dose

Treatment:

Drug: PF-06372865

Placebo

Placebo Comparator group

Description:

Single dose

Treatment:

Drug: Placebo

Lorazepam

Active Comparator group

Description:

2mg single dose

Treatment:

Drug: Lorazepam