PF-06372865 in Subjects With Photosensitive Epilepsy

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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