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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT00407797
• Date of registration: 01/12/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial PREPS MEXICO
• Scientific 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
• Date of first enrolment: March 2007
• Target sample size: 136
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00407797
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Partial Seizures

Intervention(s)

Drug: Pregabalin

Primary Outcome(s)

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)]

Secondary Outcome(s)

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)]

Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) [Time Frame: Week 21, LOCF]

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)]

Percent of Seizure- Free Participants During the Treatment Observation Period [Time Frame: Week 9 to Week 21 or Early Termination (end of treatment)]

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 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)]

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) [Time Frame: Week 21, LOCF]

Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale [Time Frame: Week 21, LOCF]

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)]

Response Ratio (RR) [Time Frame: Week 9 to Week 21 or End of Treatment (early termination)]

Treatment Satisfaction: Patient General Impression to Change (PGIC) [Time Frame: Week 21, LOCF]

Secondary ID(s)

A0081090

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/09/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00407797