Reflex Epilepsy, PhotosensitivePhase 2NCT02564029

PF-06372865 in Subjects With Photosensitive Epilepsy

A Phase 2 study testing PF-06372865 and Lorazepam in people with Reflex Epilepsy, Photosensitive, run by Pfizer at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

PF-06372865 in subjects with photosensitive epilepsy Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Reflex Epilepsy, Photosensitive
What is being tested?: PF-06372865 and Lorazepam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 16 sitesUnited States
Study dates: 16 Dec 2015to 7 Feb 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Johns Hopkins University Department of Neurology
Baltimore, Maryland, 21287-7247
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702
General Clinical Research Center (GCRC)
Nashville, Tennessee, 37232
Vanderbilt University Epilepsy Clinic
Nashville, Tennessee, 37232
Vanderbilt University Hospital Pharmacy
Nashville, Tennessee, 37232
VU Department of Neurology
Nashville, Tennessee, 37232
New York University Comprehensive Epilepsy Center
New York, New York, 10016
Clinical and Translational Research Center
Philadelphia, Pennsylvania, 19104
Hospital of the Univ of PA Pharmacy Service
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Hospital EEG lab
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Investigational Drug Service
Philadelphia, Pennsylvania, 19107
Barnes Jewish Hospital
St Louis, Missouri, 63110
Center for Advanced Medicine
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

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

PF-06372865 in subjects with photosensitive epilepsy

Conditions: Reflex Epilepsy, Photosensitive
Being tested: PF-06372865, Placebo, Lorazepam
Medical subject headings: Epilepsy, Reflex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06372865Drug
Single dose
PlaceboDrug
Placebo for PF-06372865 and placebo for lorazepam
LorazepamDrug
2 mg single oral dose

Study groups in NCT02564029
Study group	Role	What they receive
PF-06372865 dose level 1	Experimental	17.5 milligram (mg) single dose Receives: Drug: PF-06372865
PF-06372865 dose level 2	Experimental	52.5 mg single dose Receives: Drug: PF-06372865
Placebo	Placebo comparator	Single dose Receives: Drug: Placebo
Lorazepam	Active comparator	2mg single dose Receives: Drug: Lorazepam

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Pre-dose, 1, 2, 4 and 6 hours post-dose

Secondary outcomes (10)

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.
Measured: Pre-dose, 1, 2, 4 and 6 hours post-dose
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.
Measured: Pre-dose, 1, 2, 4 and 6 hours post-dose
Maximum Plasma Concentration (Cmax) of PF-06372865
Measured: 1, 2, 4 and 6 hours post-dose
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
Measured: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose
Time for Cmax (Tmax) of PF-06372865
Measured: 1, 2, 4 and 6 hours post-dose
Plasma Concentration of Lorazepam
Measured: 1, 2, 3, 4 and 6 hours post-dose
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.
Measured: 17 weeks
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
Measured: 17 weeks
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Measured: 17 weeks
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.
Measured: 19 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 20157 Feb 2017

First posted30 Sep 2015 (estimated)
Study start16 Dec 2015
Primary completion10 Jan 2017
Study completion7 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Reflex Epilepsy, PhotosensitiveStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02564029
Sponsor's protocol ID: B7431005
Status last verified: Feb 2018
First submitted: 10 Sep 2015
Last updated: 14 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gurrell R, Gorman D, Whitlock M, Ogden A, Reynolds DS, DiVentura B, Abou-Khalil B, Gelfand M, Pollard J, Hogan RE, Krauss G, Sperling M, Vazquez B, Wechsler RT, Friedman D, Butt RP, French J. Photosensitive epilepsy: Robust clinical efficacy of a selective GABA potentiator. Neurology. 2019 Apr 9;92(15):e1786-e1795. doi: 10.1212/WNL.0000000000007271. Epub 2019 Mar 15.
PubMed 30877186

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02564029
Acronym / sponsor ID: B7431005
Conditions: Reflex Epilepsy, Photosensitive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 16 Dec 2015 (actual)
Primary completion: 10 Jan 2017 (actual)
Study completion: 7 Feb 2017 (actual)
First posted: 30 Sep 2015 (estimated)
Results: Posted 14 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PF-06372865 in subjects with photosensitive epilepsy

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
PF-06372865 dose level 1	Experimental	Drug: PF-0637286517.5 milligram (mg) single dose
PF-06372865 dose level 2	Experimental	Drug: PF-0637286552.5 mg single dose
Placebo	Placebo comparator	Drug: PlaceboSingle dose
Lorazepam	Active comparator	Drug: Lorazepam2mg single dose

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06372865Single dose	Drug	PF-06372865 dose level 1, PF-06372865 dose level 2
PlaceboPlacebo for PF-06372865 and placebo for lorazepam	Drug	Placebo
Lorazepam2 mg single oral dose	Drug	Lorazepam

Primary outcome

The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
Time frame: 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.

10 secondary outcomes

The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose
The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)
Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose
Maximum Plasma Concentration (Cmax) of PF-06372865
Time frame: 1, 2, 4 and 6 hours post-dose
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
Time frame: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose
Time for Cmax (Tmax) of PF-06372865
Time frame: 1, 2, 4 and 6 hours post-dose
Plasma Concentration of Lorazepam
Time frame: 1, 2, 3, 4 and 6 hours post-dose
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Time frame: 17 weeks
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
Time frame: 17 weeks
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: 17 weeks
Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: 19 weeks

Results and safety

Results posted to the registry on 14 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	7	7

Primary outcome: The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition

Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose. Least squares mean (Standard Error). Unit: Units on a scale

Measure	PF-06372865 17.5 mg n = 7	PF-06372865 52.5 mg n = 7	Lorazepam 2 mg n = 7	Placebo n = 7
Value	0.57 (0.98)	1.38 (0.96)	1.58 (0.97)	6.80 (0.96)

PF-06372865 17.5 mg vs Placebo: Mean Difference (Final Values): -6.23 (90% CI -8.60 to -3.86), Mixed Model Repeated Measures Analysis
PF-06372865 52.5 mg vs Placebo: Mean Difference (Final Values): -5.42 (90% CI -7.78 to -3.06), Mixed Model Repeated Measures Analysis
Lorazepam 2 mg vs Placebo: Mean Difference (Final Values): -5.22 (90% CI -7.60 to -2.84), Mixed Model Repeated Measures Analysis

Population analysed: Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 19 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
PF-06372865 17.5 mg	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
PF-06372865 52.5 mg	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
Lorazepam 2 mg	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30877186Gurrell R, Gorman D, Whitlock M, Ogden A, Reynolds DS, DiVentura B, Abou-Khalil B, Gelfand M, Pollard J, Hogan RE, Krauss G, Sperling M, Vazquez B, Wechsler RT, Friedman D, Butt RP, French J. Photosensitive epilepsy: Robust clinical efficacy of a selective GABA potentiator. Neurology. 2019 Apr 9;92(15):e1786-e1795. doi: 10.1212/WNL.0000000000007271. Epub 2019 Mar 15.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06372865 and Lorazepam in people with Reflex Epilepsy, Photosensitive, run by Pfizer at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition (time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02564029, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.