Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
Overview[ - collapse ][ - ]
| Purpose | To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures. |
|---|---|
| Condition | Epilepsy Partial Seizure Disorder Epilepsies, Partial Complex Partial Seizure Disorder |
| Intervention | Drug: Pregabalin Drug: Gabapentin |
| Phase | Phase 4 |
| Sponsor | Pfizer |
| Responsible Party | Pfizer |
| ClinicalTrials.gov Identifier | NCT00537940 |
| First Received | September 28, 2007 |
| Last Updated | August 19, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 28, 2007 |
|---|---|
| Last Updated Date | August 19, 2013 |
| Start Date | February 2008 |
| Estimated Primary Completion Date | July 2013 |
| Current Primary Outcome Measures | 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] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| Brief Summary | To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Pregabalin 150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects Drug: Gabapentin 300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 488 |
| Estimated Completion Date | July 2013 |
| Estimated Primary Completion Date | July 2013 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Bulgaria, China, Costa Rica, Croatia, El Salvador, Guatemala, India, Pakistan, Peru, Portugal, Romania, Serbia, Slovakia, Spain |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00537940 |
|---|---|
| Other Study ID Numbers | A0081143 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Pfizer |
| Study Sponsor | Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| Pfizer Investigational Site | Plovdiv, Bulgaria, 4000 |
|---|---|
| Pfizer Investigational Site | Ruse 7002, Bulgaria |
| Pfizer Investigational Site | Sofia, Bulgaria, 1202 |
| Pfizer Investigational Site | Sofia, Bulgaria, 1309 |
| Pfizer Investigational Site | Sofia, Bulgaria, 1113 |
| Pfizer Investigational Site | Sofia, Bulgaria, 1606 |
| Pfizer Investigational Site | Sofia, Bulgaria, 1233 |
| Pfizer Investigational Site | Sofia, Bulgaria, 1524 |
| Pfizer Investigational Site | Varna, Bulgaria, 9010 |
| Pfizer Investigational Site | Nanjing, Jiangsu, China, 210029 |
| Pfizer Investigational Site | Xi'an, Shanxi, China, 710032 |
| Pfizer Investigational Site | Cheng Du Si Chaun, China, 610041 |
| Pfizer Investigational Site | Chongqing, China, 400016 |
| Pfizer Investigational Site | Autopista Prospero Fernandez Escazu, San Jose, Costa Rica, 2350-1000 |
| Pfizer Investigational Site | Escazu, San Jose, Costa Rica |
| Pfizer Investigational Site | San Jose, Costa Rica |
| Pfizer Investigational Site | Osijek, Croatia, 31000 |
| Pfizer Investigational Site | Zagreb, Croatia, 10000 |
| Pfizer Investigational Site | San Salvador, El Salvador |
| Pfizer Investigational Site | San Salvador, El Salvador, 24 |
| Pfizer Investigational Site | San Salvador, El Salvador, 01503 |
| Pfizer Investigational Site | Guatemala, Guatemala |
| Pfizer Investigational Site | Guatemala ciudad, Guatemala, 01014 |
| Pfizer Investigational Site | Hyderabad, Andhra Pradesh, India, 500 082 |
| Pfizer Investigational Site | Bangalore, Karnataka, India, 560 054 |
| Pfizer Investigational Site | Bangalore, Karnataka, India, 560 034 |
| Pfizer Investigational Site | Pune, Maharashtra, India, 411 011 |
| Pfizer Investigational Site | Pune, Maharashtra, India, 411 001 |
| Pfizer Investigational Site | Lucknow, Uttar Pradesh, India, 226003 |
| Pfizer Investigational Site | Lahore, Punjab, Pakistan, 54000 |
| Pfizer Investigational Site | Rawalpindi, Punjab, Pakistan, 46000 |
| Pfizer Investigational Site | Karachi, Pakistan |
| Pfizer Investigational Site | Lima, Peru, L13 |
| Pfizer Investigational Site | Lima, Peru, 27 |
| Pfizer Investigational Site | Lima, Peru, L-27 |
| Pfizer Investigational Site | Amadora, Portugal, 2700-276 |
| Pfizer Investigational Site | Coimbra, Portugal, 3000-548 |
| Pfizer Investigational Site | Porto, Portugal, 4099-001 |
| Pfizer Investigational Site | Targu Mures, Mures, Romania, 540136 |
| Pfizer Investigational Site | Bucuresti, Romania, 050098 |
| Pfizer Investigational Site | Constanta, Romania, 900591 |
| Pfizer Investigational Site | Sibiu, Romania, 550166 |
| Pfizer Investigational Site | Belgrade, Serbia, 11000 |
| Pfizer Investigational Site | Banska Bystrica, Slovakia, 975 17 |
| Pfizer Investigational Site | Bratislava, Slovakia, 826 06 |
| Pfizer Investigational Site | Bratislava, Slovakia, 813 69 |
| Pfizer Investigational Site | Kosice, Slovakia, 040 11 |
| Pfizer Investigational Site | Zilina, Slovakia, 01001 |
| Pfizer Investigational Site | Badalona, Barcelona, Spain, 08196 |
| Pfizer Investigational Site | San Sebastian, Guipuzcoa, Spain, 20014 |
| Pfizer Investigational Site | Barcelona, Spain, 08036 |
| Pfizer Investigational Site | Zaragoza, Spain, 50009 |