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Trial record 1 of 1 for:    NCT00407797
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Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial (PREPS MEXICO)

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ClinicalTrials.gov Identifier: NCT00407797
Recruitment Status : Terminated
First Posted : December 5, 2006
Results First Posted : September 9, 2010
Last Update Posted : January 25, 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 December 1, 2006
First Posted Date  ICMJE December 5, 2006
Results First Submitted Date  ICMJE August 12, 2010
Results First Posted Date  ICMJE September 9, 2010
Last Update Posted Date January 25, 2021
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase [ Time Frame: Week 9 to Week 21 or End of Treatment (early termination) ]
28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2006)
  • Clinical improvement of subjects following adjuctive treatment of pregabalin BID assessed by the % change from baseline phase in the 28 day seizure rate based on partial seizures recorded during 12 wk treatment observation phase
  • (last 12 wks of the open-label observational period)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
  • Response Ratio (RR) [ Time Frame: Week 9 to Week 21 or End of Treatment (early termination) ]
    Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.
  • Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21 [ Time Frame: Week 21 or End of Treatment (early termination) ]
    Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.
  • Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period [ Time Frame: Week 9 to Week 21 or End of Treatment (early termination) ]
    Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.
  • Percent of Seizure- Free Participants During the Treatment Observation Period [ Time Frame: Week 9 to Week 21 or Early Termination (end of treatment) ]
    Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).
  • Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period [ Time Frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) ]
    Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).
  • Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period [ Time Frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) ]
  • Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period [ Time Frame: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9) ]
  • Treatment Satisfaction: Patient General Impression to Change (PGIC) [ Time Frame: Week 21, LOCF ]
    Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.
  • Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) [ Time Frame: Week 21, LOCF ]
    Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.
  • Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale [ Time Frame: Week 21, LOCF ]
    Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b.
  • Change From Baseline in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Week 21, LOCF ]
    Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2006)
  • Response ratio (RR) defined to be a comparison between baseline seizure frequency (B) with the 12 week observation phase (F). R Ratio=100x(F-B)/(F+B).
  • Percent change in seizure frequency in subjects with <=6 Seizures and in subjects with >6 seizures during the 8 weeks baseline period.
  • Seizure free subjects during the last 12 weeks observation period.
  • Seizure free subjects during the last 4 weeks of the observation period.
  • Responder Rate 50% (Proportion of Subjects with 50% or greater reduction in Seizures frequency between baseline and the final 4 weeks of the observational period.
  • Responder rate 75% (Proportion of subjects with 75% or greater reduction in seizures frequency between baseline and the final 4 weeks of the observational period.
  • Treatment satisfaction given by the patient at the end of the study using subjects global impression of change (PGIC).
  • Percent Change in sleep interference (MOS sleep sclae) between the start and the end of the study.
  • Percent change in HADS between the start and the end of the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
Official Title  ICMJE Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin
Brief Summary The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).
Detailed Description This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Partial Seizures
Intervention  ICMJE Drug: Pregabalin
150 to 600 mg/day during 21 weeks
Study Arms  ICMJE Experimental: Pregabalin
Intervention: Drug: Pregabalin
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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 21, 2009)
136
Original Enrollment  ICMJE
 (submitted: December 1, 2006)
160
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.

Exclusion Criteria:

  • Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407797
Other Study ID Numbers  ICMJE A0081090
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 February 2011

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