Clinical trial NCT00537940: Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
Official title: A Randomized, Double-blind, Parallel-group Multi-center Comparative Flexible-dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Partial Seizure Disorder
Epilepsies, Partial
Complex Partial Seizure Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.


Eligibility criteria: Inclusion Criteria:

* Subjects (male or female) must be \> 18 years or ≤ 80 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures; partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
* Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.
* They must have had a 12 lead electrocardiogram (ECG) without clinically significant abnormal findings prior to randomization.
* Subjects must have had magnetic resonance imaging or contrast enhance computed tomography scan of the brain that demonstrated no progressive structural central nervous system abnormality at the time of the diagnosis of epilepsy.
* Women of childbearing potential must be established on an effective method of contraception during the study. Women should also have a negative pregnancy test prior to study entry.
* During the 6-week baseline period, subjects must have had a minimum of four partial seizures, with no 28 day period free of partial seizures with or without secondary generalization. A caregiver or witness must be with the subject for a sufficient duration to accurately chronicle the occurrence of seizures. These seizures must have been documented in the subject's diary.
* Subjects with electroencephalograph (EEG) testing done within 2 years of randomization. EEG abnormalities should be consistent with a diagnosis of focal-onset epilepsy.
* Signed and dated informed consent will be obtained from each subject (only include those able to consent) in accordance with the local regulatory and legal requirements.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Subjects who are willing, but need assistance for self administered questionnaires may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any to any screening tests or procedures for the study.

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or intending to become pregnant during the course of the trial.
* Subjects with other neurologic illness that could impair endpoint assessment, or patients with Lennox-Gastaut syndrome, absence seizures, status epilepticus within the 12 months prior to study entry, or with seizures due to an underlying medical illness or metabolic syndrome.
* Subjects with clinically significant liver disease or with a calculated creatinine clearance of \<60mL/min.
* Subjects with a history of lack of response, hypersensitivity or poor tolerability to gabapentin or pregabalin.
* Previous use of gabapentin or pregabalin within 2 weeks prior to screening or likelihood of engaging in these treatments during the study period.
* Use of prohibited medications as listed in the protocol in the absence of appropriate washout phase or the likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
* Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
* Subjects who are not suitable to be treated with pregabalin or gabapentin according to the respective local labeling.
* Subjects with a history of retinal abnormalities or treatment with retinotoxic agents.

Primary outcomes:
measure: Percent Change From Baseline in 28-day Seizure Frequency at Week 21.
timeFrame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Secondary outcomes:
measure: Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
timeFrame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
measure: Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
timeFrame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
measure: Percentage of Participants Without Seizures.
timeFrame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
measure: Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.
timeFrame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
measure: Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.
timeFrame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
measure: Hospital Anxiety and Depression Scale (HADS) Score.
timeFrame: Baseline, Week 21
measure: Medical Outcomes Study Sleep Scale (MOS-SS) Score.
timeFrame: Baseline, Week 21
measure: Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.
timeFrame: Baseline, Week 21
Other outcomes:
Locations:
city: San Jose
country: Costa Rica
facility: Hospital Clinica Biblica
city: San Salvador
country: El Salvador
facility: Instituto de Neurociencias
city: San Salvador
country: El Salvador
facility: Clinica de Especialidades Neurologicas
city: Guatemala Ciudad
country: Guatemala
facility: Private Office
city: Guatemala
country: Guatemala
facility: Private Office
city: Lima
country: Peru
facility: Clinica Anglo Americana
city: Lima
country: Peru
facility: Torre de Consultorios Clinica Anglo Americana
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen - Essalud
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: French J, Glue P, Friedman D, Almas M, Yardi N, Knapp L, Pitman V, Posner HB. Adjunctive pregabalin vs gabapentin for focal seizures: Interpretation of comparative outcomes. Neurology. 2016 Sep 20;87(12):1242-9. doi: 10.1212/WNL.0000000000003118. Epub 2016 Aug 12.