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

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).

Study Overview

• Status: Terminated
• Conditions: Partial Seizures
• Intervention / Treatment: Drug: Pregabalin

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: Interventional
• Enrollment (Actual): 136
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Aguascalientes, Mexico, 20127
    • Pfizer Investigational Site
  • Chihuahua, Mexico, 31238
    • Pfizer Investigational Site
  • Estado de México, Mexico, CP 52763
    • Pfizer Investigational Site
  • D. F.
    • Mexico, D. F., Mexico, CP 06700
      • Pfizer Investigational Site
  • Guerrero
    • Acapulco, Guerrero, Mexico, 39670
      • Pfizer Investigational Site
  • Michoacan
    • Morelia, Michoacan, Mexico, CP 58000
      • Pfizer Investigational Site
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64060
      • Pfizer Investigational Site
    • Monterrey,, Nuevo Leon, Mexico, 64460
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pregabalin	Drug: Pregabalin; 150 to 600 mg/day during 21 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase	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.	Week 9 to Week 21 or End of Treatment (early termination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Ratio (RR)	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.	Week 9 to Week 21 or End of Treatment (early termination)
Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21	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.	Week 21 or End of Treatment (early termination)
Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period	Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.	Week 9 to Week 21 or End of Treatment (early termination)
Percent of Seizure- Free Participants During the Treatment Observation Period	Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).	Week 9 to Week 21 or Early Termination (end of treatment)
Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period	Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).	Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period		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		Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)
Treatment Satisfaction: Patient General Impression to Change (PGIC)	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.	Week 21, LOCF
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)	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.	Week 21, LOCF
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale	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.	Week 21, LOCF
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)	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.	Week 21, LOCF

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: December 1, 2006
• First Submitted That Met QC Criteria: December 1, 2006
• First Posted (ESTIMATE): December 5, 2006

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Lyrica; Epilepsies - Partial
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081090