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

• 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: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Partial Seizures	Drug: Pregabalin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 136 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: March 2007
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pregabalin	Drug: Pregabalin; 150 to 600 mg/day during 21 weeks

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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).
5. 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).
6. 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) ]
7. 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) ]
8. 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.
9. 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.
10. 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.
11. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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, 64460

Pfizer Investigational Site

Monterrey, Nuevo Leon, Mexico, 64060

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's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00407797
• Other Study ID Numbers: A0081090
• First Posted: December 5, 2006
• Results First Posted: September 9, 2010
• Last Update Posted: January 25, 2021
• Last Verified: February 2011

Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):

Lyrica; Epilepsies - Partial

Additional relevant MeSH terms:

Seizures; Neurologic Manifestations; Nervous System Diseases; Pregabalin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs