A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
Public ClinicalTrials.gov record NCT01747915. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
Study identification
- NCT ID
- NCT01747915
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 219 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2013 (Actual)
- Primary completion
- Feb 20, 2019 (Actual)
- Completion
- Feb 20, 2019 (Actual)
- Last update posted
- Jan 20, 2021
2013 – 2019
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Axcess Medical Research | Loxahatchee Groves | Florida | 33470 | — |
| Pediatric Epilepsy Center of Central Florida | Orlando | Florida | 32819 | — |
| Pediatric Neurology, PA | Orlando | Florida | 32819 | — |
| Medsol Clinical Research Center | Port Charlotte | Florida | 33952 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | — |
| Chinmay K. Patel, D.O. | Hoffman Estates | Illinois | 60169 | — |
| St. Alexius Medical Center | Hoffman Estates | Illinois | 60169 | — |
| Ohio Clinical Research Partners, LLC | Canton | Ohio | 44718 | — |
| Road Runner Research, Ltd | San Antonio | Texas | 78249 | — |
| Scott & White Memorial Hospital and Clinic | Temple | Texas | 76508 | — |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 115 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01747915, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 20, 2021 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01747915 live on ClinicalTrials.gov.