| CTRI Number |
CTRI/2011/08/001976 [Registered on: 30/08/2011] Trial Registered Prospectively |
| Last Modified On: |
07/02/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Once-A-Day Pregabalin For Partial Seizures |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures - Protocol A0081194 |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A0081194 |
Protocol Number |
| NCT01262677 |
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 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 |
|
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 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 |
|
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, India |
|
|
Primary Sponsor
|
| 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
|
|
Countries of Recruitment
Modification(s)
|
Argentina
Bosnia and Herzegovina
Bulgaria
Croatia
Czech Republic
Germany
Hungary
India
Malaysia
Mexico
Other
Poland
Romania
Russian Federation
Serbia
Singapore
Thailand
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kulkarni |
Deenanath Mangeshkar Hospital and Research Centre |
Department of Neurology,
Deenanath Mangeshkar Hospital Road,
Erandawane, Pune
411 004
Pune
MAHARASHTRA |
91-20-66023000
91-20-66023107
rahulneuro@vsnl.net |
| Dr Kesahva |
J.S.S. Medical College and Hospital |
Department of Clinical pharmacy, Room No A 105,
Sri Shivarathreeshwara Nagara,
Ramanuja Road
Mysore 570 015
Hyderabad
ANDHRA PRADESH |
91-821-2548356
91-821-2548368
keshavabelur@gmail.com |
| Dr Nandan Yardi |
KEM Hospital Research Centre |
Sardar Moodliar Road
Rasta Peth
Pune, Maharashtra 411 011
INDIA
Pune
MAHARASHTRA |
9850066005
91-20-26055067
nandan.yardi@gmail.com |
| Dr Vijaya |
Lalitha Super Specialities Hospital Pvt. Limited |
Department of Neurology,
Heart,Brain & Multi Specialities
Kothapet, Guntur, - 522 001.
Andhra Pradesh, India
Guntur
ANDHRA PRADESH |
91-863-2332866
91-863-2332866
drvijaya.lssh@gmail.com |
| Dr Kothari |
Poona Hospital and Research Centre |
27, Sadashiv Peth
Pune
MAHARASHTRA |
91-20-24331706
91-20-24320681
sudhitkothari@gmail.com |
| Dr Sant |
Sahyadri Speciality Hospital |
30C, Erandawane
Karve Road
Pune
MAHARASHTRA |
020-25403000
020-25459117
hmsant@gmail.com |
| Dr Dwivedee |
Vidyasagar Institute of Mental Health & Neurosciences (VIMHANS) |
No.1, Institutional Area
Nehru Nagar, New Delhi 110 065, INDIA
New Delhi
DELHI |
91-11-29849010
91-11-29849036
sdclinical@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee (VIMHANS) |
Approved |
| Ethics Committee Poona Hospital and Research Centre for Dr Sudhir Kothari |
Approved |
| Institutional Ethics Committee, J.S.S. Medical College and Hospital |
Approved |
| Institutional Ethics Committee,Deenanath Mangeshkar Hospital and Research Centre |
Approved |
| KEM hospital for Dr. Nandan Yardi |
Approved |
| Lalitha Super Specialities Hospital Ethic Committee for Dr Vijaya |
Approved |
| Sahyadi Hospital LTD. Ethics committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Partial Seizures
Epilepsies, Partial
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo: Placebo Comparator
Intervention: Drug: placebo
|
Drug: placebo
matched to the active drug
|
| Intervention |
pregabalin CR 165 mg: Experimental
Interventions:
1. Drug: pregabalin
2. Drug: pregabalin
|
1. Drug: pregabalin
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
2. Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
|
| Intervention |
pregabalin CR 330 mg: Experimental Interventions:
1. Drug: pregabalin
2. Drug: pregabalin
3. Drug: pregabalin
4. Drug: pregabalin
|
1. Drug: pregabalin
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
2. Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
3. Drug: pregabalin
Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
4. Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
2. Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs . subjects need to have 6 seizures during the 8 week screening period with no 4 week period with zero seizures
In India as per DCGI Directive, subjects aged greater than equal to 18 years and les than equal to 65 years should be enrolled in the study |
|
| ExclusionCriteria |
| Details |
1. Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
2. Status epilepticus within one year prior to screening
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary endpoint will be the log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the double blind maintenance treatment phase |
Week 0 to week 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Evaluation for safety using adverse event data, medical history, PHQ 8, laboratory data, physical exams, vital signs, neurological exams, electrocardiograms, and suicidality assessment |
Screening to Week 15 |
| 2. Responder rate (proportion of subjects who have a greater than or equal to 50% reduction in partial seizure rate from baseline during the double blind maintenance treatment phase compared to the 8 week baseline (screening) seizure phase). |
Screening to Week 15 |
| 3. The percentage change in 28 day partial seizure rates summarized by treatment group |
Screening to Week 15 |
| 4. Frequency of secondary generalized tonic clonic seizures (SGTC). |
Screening to Week 15 |
| 5. Log-transformed 28 day SGTC rate for all SGTCs collected during the double blind maintenance treatment phase. |
Screening to Week 15 |
| 6. SGTC responder rate. |
Screening to Week 15 |
| 7. Changes from baseline in the anxiety and depression subscale scores of the Hospital Anxiety and Depression Scale (HADS) scores. |
Baseline to Week 14 |
| 8. Change from baseline in Medical Outcomes Study Sleep Scale (MOS Sleep Scale) subscale scores. |
Baseline to Week 14 |
| 9. Global scores on the patient rated Benefit, Satisfaction, and Willingness to Continue Measure (BSW). |
Baseline to Week 14 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="264"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
24/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/02/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is an adjunctive (add-on) therapy in adult subjects with partial onset seizures with or without secondary generalization. This study is a randomized, double-blind, placebo-controlled, parallel group multi-center trial. This compares the efficacy of 2 different dosages of pregabalin CR (165 mg and 330 mg) dosed once daily as compared to placebo when used as adjunctive (add-on) therapy in subjects requiring adjunctive therapy in partial onset epilepsy. This study was conducted at 7 sites in India with 32 subjects of which 24 subjects have entered into treatment. The study is completed and the sites are closed out. |