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Trial record 1 of 1 for:    pfizer A0081096
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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 : Completed
First Posted : July 13, 2006
Results First Posted : February 21, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
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
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : February 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Pregabalin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With a Decrease (p<0.05) From Baseline in Threshold Value in Any 5 or More Points in Humphrey 24-2 Swedish Interactive Threshold Algorithm (SITA) Standard Testing at Week 12 or Early Termination [ Time Frame: Baseline, Week 12 or Early Termination (any time up to Week 12) ]
    In this primary outcome measure, percentage of participants is reported, with a decrease in the threshold value from baseline to Week 12 or termination in any 5 or more points (in either eye) at the p<0.05 level repeated in the same 5 points on subsequent computerized automated perimetry testing (Humphrey 24-2 SITA standard). It was derived from the Humphrey 24-2 SITA standard visual field analyzer. For each eye there were 52 test points. For each test point, the Humphrey analyzer determined the threshold value for sensitivity to light by the participant. In addition, for each of the 52 points, the test provided probabilities (p<0.05, p<0.02, etc.) that a participant with normal vision of the same age would have the same result, i.e., that the measured value at that point was at or below the respective percentile of the age-specific empiric distribution at that position of the field for normal participants.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Deviation Score From Humphrey Threshold Test at Week 12 or Early Termination [ Time Frame: Baseline, Week 12 or Early Termination (any time up to Week 12) ]
    Mean deviation (MD) is a global index of visual field depression. The MD ranges from 0 decibels (no defect) to about -32 decibels (end-stage damage), higher scores indicate worse condition. It is derived from the Humphrey 24-2 SITA standard visual field analyzer. Change in mean deviation score from baseline to Week 12 or termination was computed for each participant. As planned, for each participant, the worst eye (eye with the greatest decrease in mean deviation) was used in the analysis and data is reported for same.

  2. Change From Baseline in Visual Acuity at Week 12 or Early Termination [ Time Frame: Baseline, Week 12 or Early Termination (any time up to Week 12) ]
    Visual acuity best-corrected (with glasses or best possible glasses prescription) was measured using early treatment diabetic retinopathy study (ETDRS) charts. There were 2 ETDRS charts. The letters on chart A were read using the right eye and on chart B using the left eye. The participants started from the top of the chart to down. The participants read down the chart until they reached a row where a minimum of 3 letters on a line could not be read. The participants were scored by number of letters identified correctly. Range was from 0 to 70, with higher scores indicate better visual acuity. As planned, for each participant, the worst eye (eye with the greatest decrease in visual acuity) was used in the analysis and data is reported for same.


Eligibility Criteria
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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
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
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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


Locations
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Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Study Protocol  [PDF] September 25, 2020
Statistical Analysis Plan  [PDF] September 30, 2020

More Information
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Additional Information:

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00351611    
Other Study ID Numbers: A0081096
2009-014269-25 ( EudraCT Number )
First Posted: July 13, 2006    Key Record Dates
Results First Posted: February 21, 2021
Last Update Posted: April 13, 2021
Last Verified: April 2021
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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
epilepsy partial seizure treatment with pregabalin or placebo
vision testing
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
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
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs