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

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ClinicalTrials.gov Identifier: NCT00351611
Recruitment Status : Recruiting
First Posted : July 13, 2006
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsies, Partial Drug: Lyrica (pregabalin) Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : July 26, 2006
Estimated Primary Completion Date : November 11, 2019
Estimated Study Completion Date : November 11, 2019


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Changes in vision from baseline to end of study assessed by the Humphrey Visual Field Analzyer. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Visual acuity will be assessed at the baseline and end of the study. [ Time Frame: 3 months ]
  2. Change in mean deviation score on the Humphrey Visual Field at baseline and end of the study. [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351611


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 173 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00351611     History of Changes
Other Study ID Numbers: A0081096
2009-014269-25 ( EudraCT Number )
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsies, Partial
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
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs