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.
NCT01747915
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Adult Trials: 18+ Years
- Seizures classified as Primary Generalized Tonic Clonic Seizures
- Must have at least 1 PGTC seizure in the 8 weeks prior to screening
- Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
- Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
- Signed informed consent and assent if a minor
- Ability to comply with daily seizure and dosing diary requirements and all study procedures
- A current diagnosis of febrile seizures, or seizures related to an ongoing acute
medical illness
- Focal seizures (simple partial, complex partial, or partial becoming secondarily
generalized)
- Status Epilepticus within 1 year prior to screening
- Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes
(BECTS) and Dravet syndrome
- Seizures related to drugs, alcohol, or acute medical illness
- Any change in anti-epileptic treatment regimen (type of medication or dose; VNS
alteration) within 28 days of the screening visit or during the baseline phase
- Progressive or potentially progressive structural CNS lesion or a progressive
encephalopathy.
- Progressive inborn errors of metabolism.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | 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. | ||||||
| Official Title ICMJE | 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 | 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Generalized Tonic Clonic Seizures | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 219 | ||||||
| Original Estimated Enrollment ICMJE | 168 | ||||||
| Actual Study Completion Date ICMJE | February 20, 2019 | ||||||
| Actual Primary Completion Date | February 20, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 5 Years to 65 Years (Child, Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Austria, Belarus, Bosnia and Herzegovina, Bulgaria, China, Croatia, Denmark, France, Greece, Hungary, India, Korea, Republic of, Lebanon, Malaysia, Montenegro, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Turkey, Ukraine, United Kingdom, United States | ||||||
| Removed Location Countries | Argentina, Belgium, Estonia, Germany, Israel, Lithuania, Netherlands, Singapore | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01747915 | ||||||
| Other Study ID Numbers ICMJE | A0081105 2010-023263-18 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | ||||||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | August 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||