| CTRI Number |
CTRI/2009/091/000422 [Registered on: 03/07/2009] |
| Last Modified On: |
03/02/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Study of Pregabalin and Gabapentin as Adjunctive Therapy in Subjects With Partial Seizures |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-Blind, Parallel-Group, Multi-Center, Comparative, Flexible Dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A0081143 |
Protocol Number |
| NCT00537940 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Director-Compliance Oversight |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Director-Compliance Oversight |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Director-Compliance Oversight |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Limited,
Pfizer Centre, Patel Estate,
S. V. Road, Jogeshwari West,
Mumbai 400 102
|
|
Primary Sponsor
Modification(s)
|
| Name |
Pfizer Limited |
| Address |
Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
Bulgaria
China
Costa Rica
Croatia
El Salvador
Guatemala
India
Pakistan
Peru
Portugal
Romania
Serbia
Slovakia
Spain |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rakesh Shukla |
Chhatrapati Sahuji Maharaj |
Medical University, Department of Neurology,-226003
Lucknow
UTTAR PRADESH |
91-9415007015
91-522-2258692
rakeshshukla_rakesh@rediffmail.com |
| Dr. Sunil Bandishti |
Grant Medical Foundation |
Ruby Hall Clinic,40, Sassoon Road-411001
Pune
MAHARASHTRA |
91-9822014423
020-26124529
sunilbandishti@yahoo.co.in |
| Dr Nandan Balkrishna Yardi |
KEM Hospital Research Centre |
Sardar Moodliar Road,Rasta Peth-411 011
Pune
MAHARASHTRA |
91-9850066005
91-20-26055067
nandan.yardi@gmail.com |
| Dr. Rangasetty Srinivasa |
M S Ramaiah Memorial Hospital Gokula METROPOLIS Clinical Research Centre |
Department of Neurology,New BEL Road, MSRIT Post-560054
Bangalore
KARNATAKA |
91-9448040589
91-80-40528402
drrsrinivasa@hotmail.com |
| Dr Gosala Raja Kukkuta Sarma |
St. Johns Medical College Hospital |
Department of Neurology,Sarjapur Road-560 034
Bangalore
KARNATAKA |
080-22065330
91-80-25634479
grk_sarma@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethical Review Board M S Ramaiah Medical College and Teaching Hospital Bangalore |
Approved |
| Ethics Committee KEM Hospital Research Centre |
Approved |
| Ethics Committee Poona Medical Research Foundation |
Approved |
| Institutional Ethical Review Board St. Johns Medical College and Hospital Bangalore |
Approved |
| Institutional Ethics Committee Office of the Research Cell Lucknow |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Epilepsy, Partial Seizure Disorder, Epilepsies, Partial, Complex Partial Seizure Disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gabapentin |
300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects |
| Intervention |
Pregabalin |
150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects (male or female) must be greater than 18 years or lessthan equal to 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.
2.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.
3.They must have had a 12 lead electrocardiogram (ECG) without clinically significant abnormal findings prior to randomization. (Note: This is acquired as part of the Screening process).
4.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.
5.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.
6.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 subjects diary.
7.Subjects with electroencephalograph (EEG) testing done within 2 years of randomization. EEG abnormalities should be consistent with a diagnosis of focal-onset epilepsy.
8.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.
9.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.
|
|
| ExclusionCriteria |
| Details |
1.Females who are pregnant, breastfeeding, or intending to become pregnant during the course of the trial.
2.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.
3.Subjects with clinically significant liver disease or with a calculated creatinine clearance of <60mL/min.
4.Subjects with a history of lack of response, hypersensitivity or poor tolerability to gabapentin or pregabalin.
5.Previous use of gabapentin or pregabalin within 2 weeks prior to screening or likelihood of engaging in these treatments during the study period.
6.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.
7.Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
8.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.
9.Subjects who are not suitable to be treated with pregabalin or gabapentin according to the respective local labeling.
10.Subjects with a history of retinal abnormalities or treatment with retinotoxic agents.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
27 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 2. Proportion of subjects who had at least a 75% reduction in seizure rate during the maintenance phase, as measured from baseline. |
27 Weeks |
| Time to dose maintenance following seizure freedom |
27 Weeks |
| Change from baseline to trial end on the Medical Outcomes Study-Sleep Scale |
22 Weeks |
| Seizure free rate defined as proportion of subjects with no seizure during the maintenance phase, as measured from baseline |
27 Weeks |
| 1. 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 |
27 Weeks |
| Change in frequency of secondarily generalized tonic-clonic (SGTC) seizures. |
27 Weeks |
| Change from baseline to trial end on the Hospital Anxiety and Depression Scale (HADS). |
22 Weeks |
| Safety and tolerability of pregabalin and gabapentin |
27 Weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="520"
Sample Size from India="95"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/07/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
12/02/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It is a randomized, controlled, double-blind, double dummy, flexible dose, comparative, two-arm parallel-group trial in subjects with refractory partial seizures, with or without secondary generalization. Flexible doses of pregabalin (300-600 mg/day flexible dose) or gabapentin (1200-1800 mg/day flexible dose) will be used as adjunctive therapy in subjects with partial seizures. In order to have 520 subjects randomized, approximately 800 subjects will be screened. This study is being conducted in 5 sites in India with 95 subjects. |