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

Condition(s) targeted: Epilepsy; Partial Seizure Disorder; Epilepsies, Partial; Complex Partial Seizure Disorder

Intervention: Pregabalin (Drug); Gabapentin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To compare the efficacy 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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.

Proportion of subjects who had at least a 75% reduction in seizure rate during the maintenance phase, as measured from baseline.

Time to dose maintenance following seizure freedom.

Change from baseline to trial end on the Medical Outcomes Study-Sleep Scale.

Seizure free rate defined as proportion of subjects with no seizure during the maintenance phase, as measured from baseline.

Change in frequency of secondarily generalized tonic-clonic (SGTC) seizures.

Change from baseline to trial end on the Hospital Anxiety and Depression Scale (HADS).

Safety and tolerability of pregabalin and gabapentin

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Plovdiv 4000, Bulgaria; Recruiting

Pfizer Investigational Site, Ruse 7002, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1113, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1524, Bulgaria; Not yet recruiting

Pfizer Investigational Site, Sofia 1309, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1606, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1233, Bulgaria; Not yet recruiting

Pfizer Investigational Site, Sofia 1202, Bulgaria; Recruiting

Pfizer Investigational Site, Varna 9010, Bulgaria; Recruiting

Pfizer Investigational Site, Cheng Du Si Chaun 610041, China; Recruiting

Pfizer Investigational Site, Chongqing 400016, China; Active, not recruiting

Pfizer Investigational Site, San Jose, Costa Rica; Recruiting

Pfizer Investigational Site, Osijek 31000, Croatia; Recruiting

Pfizer Investigational Site, Zagreb 10000, Croatia; Recruiting

Pfizer Investigational Site, San Salvador 24, El Salvador; Recruiting

Pfizer Investigational Site, San Salvador, El Salvador; Recruiting

Pfizer Investigational Site, San Salvador 01503, El Salvador; Recruiting

Pfizer Investigational Site, Ciudad de Guatemala, Guatemala; Recruiting

Pfizer Investigational Site, Guatemala ciudad 01014, Guatemala; Recruiting

Pfizer Investigational Site, Bangalore 560 034, India; Recruiting

Pfizer Investigational Site, Bangalore 560 054, India; Recruiting

Pfizer Investigational Site, Karachi, Pakistan; Recruiting

Pfizer Investigational Site, Lima L-27, Peru; Recruiting

Pfizer Investigational Site, Lima 27, Peru; Recruiting

Pfizer Investigational Site, Lima L13, Peru; Recruiting

Pfizer Investigational Site, Amadora 2700-276, Portugal; Terminated

Pfizer Investigational Site, Coimbra 3000-548, Portugal; Recruiting

Pfizer Investigational Site, Porto 4099-001, Portugal; Recruiting

Pfizer Investigational Site, Bucuresti 050098, Romania; Recruiting

Pfizer Investigational Site, Sibiu 550166, Romania; Recruiting

Pfizer Investigational Site, Belgrade 11000, Serbia; Recruiting

Pfizer Investigational Site, Banska Bystrica 975 17, Slovakia; Recruiting

Pfizer Investigational Site, Bratislava 826 06, Slovakia; Recruiting

Pfizer Investigational Site, Bratislava 813 69, Slovakia; Recruiting

Pfizer Investigational Site, Kosice 040 11, Slovakia; Recruiting

Pfizer Investigational Site, Zilina 01001, Slovakia; Recruiting

Pfizer Investigational Site, Barcelona 08036, Spain; Terminated

Pfizer Investigational Site, Zaragoza 50009, Spain; Terminated

Pfizer Investigational Site, Constanta, 900591, Romania; Recruiting

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 082, India; Terminated

Pfizer Investigational Site, Badalona, Barcelona 08196, Spain; Terminated

Pfizer Investigational Site, San Sebastian, Guipuzcoa 20014, Spain; Terminated

Pfizer Investigational Site, Nanjing, Jiangsu Province 210029, China; Active, not recruiting

Pfizer Investigational Site, Bangalore, Karnataka 560 054, India; Recruiting

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India; Recruiting

Pfizer Investigational Site, Pune, Maharashtra 411 011, India; Recruiting

Pfizer Investigational Site, Pune, Maharashtra 411 001, India; Recruiting

Pfizer Investigational Site, Pune, Maharashtra, India; Recruiting

Pfizer Investigational Site, Targu Mures, Mures 540136, Romania; Recruiting

Pfizer Investigational Site, Lahore, Punjab 54000, Pakistan; Recruiting

Pfizer Investigational Site, Rawalpindi, Punjab 46000, Pakistan; Recruiting

Pfizer Investigational Site, Escazu, San Jose 2350-1000, Costa Rica; Recruiting

Pfizer Investigational Site, Escazu, San Jose, Costa Rica; Terminated

Pfizer Investigational Site, Xi'an, Shanxi Province 710032, China; Active, not recruiting

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226003, India; Recruiting

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

Starting date: February 2008
Last updated: September 13, 2010