Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial (PREPS MEXICO)

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00407797
First received: December 1, 2006
Last updated: February 4, 2011
Last verified: February 2011

December 1, 2006
February 4, 2011
March 2007
August 2009   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
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.
  • 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)
Complete list of historical versions of study NCT00407797 on ClinicalTrials.gov Archive Site
  • Response Ratio (RR) [ Time Frame: Week 9 to Week 21 or End of Treatment (early termination) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Treatment Satisfaction: Patient General Impression to Change (PGIC) [ Time Frame: Week 21, LOCF ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • 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.
Not Provided
Not Provided
 
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
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

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).

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Partial Seizures
Drug: Pregabalin
150 to 600 mg/day during 21 weeks
Experimental: Pregabalin
Intervention: Drug: Pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
136
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00407797
A0081090
No
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

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