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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. )

Tracking Information
First Submitted Date  ICMJE July 11, 2006
First Posted Date  ICMJE July 13, 2006
Results First Submitted Date  ICMJE February 1, 2021
Results First Posted Date  ICMJE February 21, 2021
Last Update Posted Date April 13, 2021
Actual Study Start Date  ICMJE July 26, 2006
Actual Primary Completion Date February 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2006)
Visual field changes, if there is any, while comparing before and after the study drug or placebo consumption will be assessed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2021)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2006)
Visual acuity will be assessed at the beginning and end of the study as well.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Drug: Lyrica (pregabalin)
    150 mg twice a day, oral administration
  • Drug: placebo
    Twice a day, oral administration
Study Arms  ICMJE
  • Experimental: Active
    Active drug
    Intervention: Drug: Lyrica (pregabalin)
  • Placebo Comparator: Placebo
    placebo comparator
    Intervention: Drug: placebo
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
 (submitted: October 19, 2020)
187
Original Enrollment  ICMJE
 (submitted: July 11, 2006)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
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
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP