NCT02564029 is a Phase 2 clinical trial of PF-06372865 in Reflex Epilepsy, Photosensitive, sponsored by Pfizer.

Who is sponsoring NCT02564029?

NCT02564029 is sponsored by Pfizer.

What drugs are being tested in NCT02564029?

Interventions in NCT02564029: PF-06372865, Placebo, Lorazepam.

What condition does NCT02564029 study?

NCT02564029 studies Reflex Epilepsy, Photosensitive.

Is NCT02564029 still recruiting?

NCT02564029 is currently completed. Last updated 14 March 2018.

Are results published for NCT02564029?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-14 · How we verify

NCT02564029

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PF-06372865 in Subjects With Photosensitive Epilepsy

Completed Phase 2 Results posted Last updated 14 March 2018

What this trial tests

Phase 2 trial testing PF-06372865 in Reflex Epilepsy, Photosensitive in 7 participants. Completed in 7 February 2017.

Timeline

16 December 2015

Primary endpoint
10 January 2017

7 February 2017

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	7
Start date	16 December 2015
Primary completion	10 January 2017
Estimated completion	7 February 2017
Sites	16 locations across United States

Drugs / interventions tested

PF-06372865 — full drug profile →
Placebo
Lorazepam (lorazepam) — full drug profile →

Conditions studied

Reflex Epilepsy, Photosensitive — all drugs for Reflex Epilepsy, Photosensitive →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 60, any sex, with Reflex Epilepsy, Photosensitive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition Primary · Pre-dose, 1, 2, 4 and 6 hours post-dose

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.

Group	Value	95% CI
PF-06372865 17.5 mg	0.57	± 0.98
PF-06372865 52.5 mg	1.38	± 0.96
Lorazepam 2 mg	1.58	± 0.97
Placebo	6.80	± 0.96

The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition Secondary · Pre-dose, 1, 2, 4 and 6 hours post-dose

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.

Eye Closure

Group	Value	95% CI
PF-06372865 17.5 mg	0.57	± 0.98
PF-06372865 52.5 mg	1.38	± 0.96
Lorazepam 2 mg	1.58	± 0.97
Placebo	6.80	± 0.96

Eyes Closed

Group	Value	95% CI
PF-06372865 17.5 mg	0.33	± 0.57
PF-06372865 52.5 mg	0.40	± 0.57
Lorazepam 2 mg	1.09	± 0.57
Placebo	6.84	± 0.64

Eyes Open

Group	Value	95% CI
PF-06372865 17.5 mg	0.04	± 0.46
PF-06372865 52.5 mg	0.09	± 0.46
Lorazepam 2 mg	0.08	± 0.46
Placebo	4.46	± 0.51

The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) Secondary · Pre-dose, 1, 2, 4 and 6 hours post-dose

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.

Complete suppression

Group	Value	95% CI
PF-06372865 17.5 mg	85.7
PF-06372865 52.5 mg	85.7
Lorazepam 2 mg	85.7
Placebo	28.6

Partial response

Group	Value	95% CI
PF-06372865 17.5 mg	0
PF-06372865 52.5 mg	0
Lorazepam 2 mg	0
Placebo	0

No response

Group	Value	95% CI
PF-06372865 17.5 mg	14.3
PF-06372865 52.5 mg	14.3
Lorazepam 2 mg	14.3
Placebo	71.4

Maximum Plasma Concentration (Cmax) of PF-06372865 Secondary · 1, 2, 4 and 6 hours post-dose

Group	Value	95% CI
PF-06372865 17.5 mg	81.30	± 23
PF-06372865 52.5 mg	200.6	± 45

Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 Secondary · Pre-dose, 1, 2, 3, 4 and 6 hours post-dose

Group	Value	95% CI
PF-06372865 17.5 mg	331.3	± 22
PF-06372865 52.5 mg	771.4	± 56

Time for Cmax (Tmax) of PF-06372865 Secondary · 1, 2, 4 and 6 hours post-dose

Group	Value	95% CI
PF-06372865 17.5 mg	2.12	1.02 – 3.03
PF-06372865 52.5 mg	3.02	1.98 – 5.95

Plasma Concentration of Lorazepam Secondary · 1, 2, 3, 4 and 6 hours post-dose

1 hours post dose

Group	Value	95% CI
Lorazepam 2 mg	7.38	± 5.92

2 hours post dose

Group	Value	95% CI
Lorazepam 2 mg	13.32	± 6.67

3 hours post dose

Group	Value	95% CI
Lorazepam 2 mg	17.10	± 4.32

4 hours post dose

Group	Value	95% CI
Lorazepam 2 mg	17.87	± 2.97

6 hours post dose

Group	Value	95% CI
Lorazepam 2 mg	15.93	± 1.92

Number of Participants With Clinically Significant Laboratory Test Abnormalities Secondary · 17 weeks

Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.

Group	Value	95% CI
PF-06372865 17.5 mg	0
PF-06372865 52.5 mg	0
Lorazepam 2 mg	0
Placebo	0

Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate Secondary · 17 weeks

Group	Value	95% CI
PF-06372865 17.5 mg	0
PF-06372865 52.5 mg	0
Lorazepam 2 mg	0
Placebo	0

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings Secondary · 17 weeks

Group	Value	95% CI
PF-06372865 17.5 mg	0
PF-06372865 52.5 mg	0
Lorazepam 2 mg	0
Placebo	0

Number of Participants With Treatment-emergent Adverse Events (AEs) Secondary · 19 weeks

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.

Treatment-emergent non serious AEs

Group	Value	95% CI
PF-06372865 17.5 mg	4
PF-06372865 52.5 mg	6
Lorazepam 2 mg	6
Placebo	5

Treatment-emergent serious AEs

Group	Value	95% CI
PF-06372865 17.5 mg	0
PF-06372865 52.5 mg	0
Lorazepam 2 mg	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 19 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/7 (0%)

Deaths: 0/7

PF-06372865 17.5 mg

Serious: 0/7 (0%)

Deaths: 0/7

PF-06372865 52.5 mg

Serious: 0/7 (0%)

Deaths: 0/7

Lorazepam 2 mg

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (23 terms — click to expand)

Reaction	System	Placebo	PF-06372865 17.5 mg	PF-06372865 52.5 mg	Lorazepam 2 mg
Somnolence	Nervous system disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Feeling hot	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—
Balance disorder	Nervous system disorders	—	—	—	—
Disturbance in attention	Nervous system disorders	—	—	—	—
Dysarthria	Nervous system disorders	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—
Euphoric mood	Psychiatric disorders	—	—	—	—
Irritability	Psychiatric disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT02564029 adverse events section.

Sponsor's own description

PF-06372865 in subjects with photosensitive epilepsy

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Photosensitive epilepsy: Robust clinical efficacy of a selective GABA potentiator.
Gurrell R, Gorman D, Whitlock M, Ogden A, et al · · 2019 · cited 23× · PMID 30877186 · DOI 10.1212/wnl.0000000000007271
Epilepsy Characteristics in Neurodevelopmental Disorders: Research from Patient Cohorts and Animal Models Focusing on Autism Spectrum Disorder.
Chakraborty S, Parayil R, Mishra S, Nongthomba U, et al · · 2022 · cited 18× · PMID 36142719 · DOI 10.3390/ijms231810807
Pathophysiology to Risk Factor and Therapeutics to Treatment Strategies on Epilepsy.
Boleti APA, Cardoso PHO, Frihling BEF, de Moraes LFRN, et al · · 2024 · cited 14× · PMID 38248286 · DOI 10.3390/brainsci14010071

Verify or expand the search:

Other trials of PF-06372865

Trials testing the same drug.

NCT03351751 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects · Phase 1 · completed

Other recruiting trials for Reflex Epilepsy, Photosensitive

Currently open trials in the same condition.

NCT04076410 — Efficacy of Lenses in Abolishing Photoparoxysmal Responses · NA · active not recruiting

Other Pfizer trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02564029 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 14 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02564029.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02564029

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of PF-06372865

Other recruiting trials for Reflex Epilepsy, Photosensitive

Other Pfizer trials

Verify against primary sources