Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
NCT00351611
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- Epilepsy partial seizure subjects.
- Currently taking 1 to 3 antiepileptic drugs.
- Pre-existing eye diseases (glaucoma).
- Insufficient response to pregabalin in the treatment of partial seizure, or patients
currently receiving pregabalin treatment.
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Descriptive Information | |||||||
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Brief Title ICMJE | Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo | ||||||
Official Title ICMJE | PROSPECTIVE RANDOMIZED 12-WEEK CONTROLLED STUDY OF VISUAL FIELD CHANGE IN SUBJECTS WITH PARTIAL SEIZURES RECEIVING PREGABALIN OR PLACEBO | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE | Epilepsies, Partial | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 187 | ||||||
Original Enrollment ICMJE | 284 | ||||||
Actual Study Completion Date ICMJE | February 4, 2020 | ||||||
Actual Primary Completion Date | February 4, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Bulgaria, Czechia, Hungary, India, Korea, Republic of, Mexico, Poland, Thailand, United States | ||||||
Removed Location Countries | Czech Republic | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00351611 | ||||||
Other Study ID Numbers ICMJE | A0081096 2009-014269-25 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | ||||||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |