Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2013
• Main ID: NCT00537940
• Date of registration: 28/09/2007
• Primary sponsor: Pfizer
• Public title: Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
• Scientific 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
• Date of first enrolment: February 2008
• Target sample size: 520
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00537940
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

Bulgaria, China, Costa Rica, Croatia, El Salvador, Guatemala, India, Pakistan, Peru, Portugal, Romania, Serbia, Slovakia, Spain

Contacts

• Name: Pfizer CT.gov Call Center

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

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Complex Partial Seizure Disorder

Epilepsies, Partial

Epilepsy

Partial Seizure Disorder

Intervention(s)

Drug: Gabapentin

Drug: Pregabalin

Primary Outcome(s)

Change in seizure count frequency from baseline to endpoint, calculated as the percent change in seizure frequency during the maintenance phase of treatment compared to baseline. [Time Frame: 27 weeks]

Secondary Outcome(s)

Change from baseline to trial end on the Hospital Anxiety and Depression Scale (HADS). [Time Frame: 22 weeks]

Change from baseline to trial end on the Medical Outcomes Study-Sleep Scale. [Time Frame: 22 weeks]

Change in frequency of secondarily generalized tonic-clonic (SGTC) seizures. [Time Frame: 27 weeks]

Proportion of subjects who had at least a 75% reduction in seizure rate during the maintenance phase, as measured from baseline. [Time Frame: 27 weeks]

Responder rate, defined as the proportion of subjects who had at least a 50% reduction in seizure rate during the maintenance phase, as measured from baseline. [Time Frame: 27 weeks]

Safety and tolerability of pregabalin and gabapentin [Time Frame: 27 weeks]

Seizure free rate defined as proportion of subjects with no seizure during the maintenance phase, as measured from baseline. [Time Frame: 27 weeks]

Time to dose maintenance following seizure freedom. [Time Frame: 27 weeks]

Secondary ID(s)

A0081143

Source(s) of Monetary Support

Please refer to primary and secondary sponsors