Trial · NCT02564029
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | 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. |
| Secondary | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | 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. |
| Secondary | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | 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. |
| Secondary | Maximum Plasma Concentration (Cmax) of PF-06372865 | 1, 2, 4 and 6 hours post-dose | |
| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 | Pre-dose, 1, 2, 3, 4 and 6 hours post-dose | |
| Secondary | Time for Cmax (Tmax) of PF-06372865 | 1, 2, 4 and 6 hours post-dose | |
| Secondary | Plasma Concentration of Lorazepam | 1, 2, 3, 4 and 6 hours post-dose | |
| Secondary | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 17 weeks | Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests. |
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | 17 weeks | |
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | 17 weeks | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT02564029/registered