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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
  Purpose

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).


Condition Intervention Phase
Partial Seizures
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 136
Study Start Date: March 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin Drug: Pregabalin
150 to 600 mg/day during 21 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407797

Locations
Mexico
Pfizer Investigational Site
Mexico, D. F., Mexico, CP 06700
Pfizer Investigational Site
Acapulco, Guerrero, Mexico, 39670
Pfizer Investigational Site
Morelia, Michoacan, Mexico, CP 58000
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64060
Pfizer Investigational Site
Monterrey,, Nuevo Leon, Mexico, 64460
Pfizer Investigational Site
Aguascalientes, Mexico, 20127
Pfizer Investigational Site
Chihuahua, Mexico, 31238
Pfizer Investigational Site
Estado de México, Mexico, CP 52763
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00407797     History of Changes
Other Study ID Numbers: A0081090
Study First Received: December 1, 2006
Results First Received: August 12, 2010
Last Updated: February 4, 2011
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Pfizer:
Lyrica
Epilepsies - Partial

Additional relevant MeSH terms:
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014