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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351611
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : December 11, 2020
Information provided by (Responsible Party):

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : July 26, 2006
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : February 4, 2020

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

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00351611

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT00351611    
Other Study ID Numbers: A0081096
2009-014269-25 ( EudraCT Number )
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:

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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:
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Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs