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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00288639
Other study ID # A0081088
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2005
Est. completion date December 2007

Study information

Verified date November 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit - Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion Exclusion Criteria: - AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures - Having absences seizures - Having had status epileptics within the year prior to inclusion - Having a progressive neurological or systematic disorder - Having known significant renal or hepatic dysfunction

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pregabalin
Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID). Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID).

Locations

Country Name City State
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Heraklio
Greece Pfizer Investigational Site Mesogion, Athen
Greece Pfizer Investigational Site Patras
Greece Pfizer Investigational Site Thessaloniki
Greece Pfizer Investigational Site Thessaloniki
Greece Pfizer Investigational Site Thessaloniki

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period). 8 week baseline period & 12 week treatment observation period
Secondary Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period. Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. 8 week baseline period and 21 week treatment period
Secondary Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period. Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. 8 week baseline period and 21 week treatment period
Secondary Number of Subjects Seizure-free Count of subjects seizure free during the period. last 4 weeks & whole 12 week treatment observation period
Secondary Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period. Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period. 8 week baseline observation period & last 4 weeks of observation period
Secondary Subjects Achieving Seizure Freedom During Observation Period Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period. Day 147 from the first dose of study drug
Secondary Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. 8 week baseline observation period & 12 week treatment observation period
Secondary Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC) The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). End of 21-week treatment
Secondary Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC) The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). End of 21-week treatment
Secondary Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1. Baseline, end of 21-week treatment
Secondary Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21. Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21. Baseline, End of 21-week treatment
Secondary Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline Count of subjects with a weight gain of at least 7 percent relative to baseline. Baseline, End of 21-week treatment
Secondary Subjects Assessment of Optimal Sleep Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale. Baseline, End of 21-week treatment
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