Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00351611
First received: July 11, 2006
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment. Vision testing will be performed prior to receiving the study treatment and at the end of the study to see if there are any changes.


Condition Intervention Phase
Epilepsies, Partial
Drug: Lyrica (pregabalin)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized 12-Week Controlled Study Of Visual Field Change In Subjects With Partial Seizures Receiving Pregabalin Or Placebo

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Changes in vision from baseline to end of study assessed by the Humphrey Visual Field Analzyer. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual acuity will be assessed at the baseline and end of the study. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Change in mean deviation score on the Humphrey Visual Field at baseline and end of the study. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 284
Study Start Date: July 2006
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Active drug
Drug: Lyrica (pregabalin)
150 mg twice a day, oral administration
Placebo Comparator: Placebo
placebo comparator
Drug: placebo
Twice a day, oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epilepsy partial seizure subjects.
  • Currently taking 1 to 3 antiepileptic drugs.

Exclusion Criteria:

  • Pre-existing eye diseases (glaucoma).
  • Insufficient response to pregabalin in the treatment of partial seizure, or patients currently receiving pregabalin treatment.
  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: NCT00351611

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

  Show 107 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: NCT00351611     History of Changes
Other Study ID Numbers: A0081096
Study First Received: July 11, 2006
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
epilepsy partial seizure treatment with pregabalin or placebo
vision testing

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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014