A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-Obvn Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Tonic Clonic Seizures
Intervention: Pregabalin Dose Level 1 (Drug); Pregabalin Dose Level 2 (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo during the double blind assessment phase.
Secondary outcome: Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day PGTC seizure.
Eligibility
Minimum age: 5 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2013
Last updated: January 29, 2013
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