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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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01747915
First received: November 27, 2012
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Generalized Tonic Clonic Seizures
Drug: Pregabalin Dose Level 1
Drug: Pregabalin Dose Level 2
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo during the double blind assessment phase. [ Time Frame: Daily PGTC seizure counts collected for up to 21 weeks ] [ Designated as safety issue: No ]
    Percent reduction of subject and/or caregiver reported PGTC seizures during the double-blind asessment phase, collected using a daily seizure diary.


Secondary Outcome Measures:
  • Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day PGTC seizure. [ Time Frame: Calculated from daily data from baseline to end of study for up to 21 weeks ] [ Designated as safety issue: No ]
    The proportion of subjects who have at least a 50% reduction in 28 day PGTC seizure rate during the double-blind assessment phase, as measured from baseline (data collected during the 8 week baseline phase) using Seizure Diary data.


Estimated Enrollment: 168
Study Start Date: April 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Drug Level 1 Drug: Pregabalin Dose Level 1
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Other Name: Lyrica Dose Level 1
Experimental: Study Drug Level 2 Drug: Pregabalin Dose Level 2
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Other Name: Lyrica Dose Level 2
Placebo Comparator: Placebo Drug: Placebo
Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747915

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 70 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01747915     History of Changes
Other Study ID Numbers: A0081105, 2010-023263-18
Study First Received: November 27, 2012
Last Updated: November 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Primary Generalized Tonic Clonic Seizures
Epilepsy
Safety
Efficacy
Tolerability
Pregabalin
Lyrica
Adjunctive treatment
Placebo Controlled
Blinded

Additional relevant MeSH terms:
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014