Clinical trial NCT00407797: Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Partial Seizures
Keywords: Lyrica
Epilepsies - Partial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-05
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase
timeFrame: Week 9 to Week 21 or End of Treatment (early termination)
Secondary outcomes:
measure: Response Ratio (RR)
timeFrame: Week 9 to Week 21 or End of Treatment (early termination)
measure: Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21
timeFrame: Week 21 or End of Treatment (early termination)
measure: Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period
timeFrame: Week 9 to Week 21 or End of Treatment (early termination)
measure: Percent of Seizure- Free Participants During the Treatment Observation Period
timeFrame: Week 9 to Week 21 or Early Termination (end of treatment)
measure: Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period
timeFrame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
measure: Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
timeFrame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
measure: Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
timeFrame: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)
measure: Treatment Satisfaction: Patient General Impression to Change (PGIC)
timeFrame: Week 21, LOCF
measure: Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
timeFrame: Week 21, LOCF
measure: Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale
timeFrame: Week 21, LOCF
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 21, LOCF
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D. F.
city: Acapulco
country: Mexico
facility: Pfizer Investigational Site
state: Guerrero
city: Morelia
country: Mexico
facility: Pfizer Investigational Site
state: Michoacan
city: Monterrey,
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Pfizer Investigational Site
city: Chihuahua
country: Mexico
facility: Pfizer Investigational Site
city: Estado de México
country: Mexico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: