Once-A-Day Pregabalin For Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01262677
First received: December 16, 2010
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.


Condition Intervention Phase
Partial Seizures
Epilepsies, Partial
Drug: pregabalin
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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures - Protocol A0081194

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary endpoint will be the log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the double blind treatment phase. [ Time Frame: Week 0 to week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation for safety using adverse event data, medical history, PHQ 8, laboratory data, physical exams, vital signs, neurological exams, electrocardiograms, and suicidality assessment. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: Yes ]
  • Responder rate (proportion of subjects who have a greater than or equal to 50% reduction in partial seizure rate from baseline during the double blind treatment phase compared to the 8 week baseline (screening) seizure phase). [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
  • The percentage change in 28 day partial seizure rates summarized by treatment group. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
  • Frequency of secondary generalized tonic clonic seizures (SGTC). [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
  • Log-transformed 28 day SGTC rate for all SGTCs collected during the double blind treatment phase. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
  • SGTC responder rate. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
  • Changes from baseline in the anxiety and depression subscale scores of the Hospital Anxiety and Depression Scale (HADS) scores. [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
  • Change from baseline in Medical Outcomes Study Sleep Scale (MOS Sleep Scale) subscale scores. [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
  • Global scores on the patient rated Benefit, Satisfaction, and Willingness to Continue Measure (BSW). [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pregabalin CR 330 mg Drug: pregabalin
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
Drug: pregabalin
Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
Experimental: pregabalin CR 165 mg Drug: pregabalin
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
Placebo Comparator: Placebo Drug: placebo
matched to the active drug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
  • Currently taking 1 to 3 anit-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

  • Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
  • Status epilepticus within one year prior to screening
  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: NCT01262677

  Show 81 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: NCT01262677     History of Changes
Other Study ID Numbers: A0081194
Study First Received: December 16, 2010
Last Updated: September 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Partial epilepsy
partial seizures
epilepsy
seizures
adjunctive therapy
intervention
controlled-release
placebo-controlled
seizure

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014