| CTRI Number |
CTRI/2011/07/001898 [Registered on: 19/07/2011] Trial Registered Prospectively |
| Last Modified On: |
06/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
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Public Title of Study
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A study to determine that long term safety and efficacy of an anti-epileptic drug Brivaracetam when used in combination with other agents in adult patients with epilepsy or fits (partial onset seizures) |
Scientific Title of Study
Modification(s)
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An Open label, Multicentre, Follow up study to evaluate the long term safety and efficacy of Brivaracetam used as adjunctive treatment in subject aged 16 years or older with Epilepsy |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| N01379 |
Protocol Number |
| NCT01339559, Protocol Amendment 3 dated 15 May 2015 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Aparna Parikh |
| Designation |
Executive Director & Country Consultant for India |
| Affiliation |
Pharmaceutical Research Associates India Pvt. Ltd |
| Address |
The Qube, A-603, C.T.S.No.1498 A/2
M.V. Road, Marol, Andheri (East), Mumbai
Mumbai (Suburban)
The Qube, A-603, C.T.S.No.1498 A/2 M.V. Road, Marol, Andheri (East), Mumbai Mumbai (Suburban)
Mumbai
MAHARASHTRA
400053
India |
| Phone |
91-2271234107 |
| Fax |
91-2271234198 |
| Email |
ParikhAparna@prahs.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Jigar Lakhani |
| Designation |
Clinical Team Manager |
| Affiliation |
Pharmaceutical Research Associates India Pvt. Ltd |
| Address |
The Qube, A-603, C.T.S.No.1498 A/2 M.V. Road, Marol, Andheri (East), Mumbai Mumbai (Suburban)
The Qube,A-603, C.T.S.No.1498 A/2 M.V. Road, Marol, Andheri (East), Mumbai Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400 059
India |
| Phone |
91-2271234129 |
| Fax |
91-2271234198 |
| Email |
LakhaniJigar@prahs.com |
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Source of Monetary or Material Support
Modification(s)
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| UCB BIOSCIENCES, INC., 8010 Arco Corporate Drive, Suite 100 Raleigh, NC 27617 UNITED STATES |
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Primary Sponsor
|
| Name |
SCHWARZ BIOSCIENCES INC A Member of the UCB Group of Companies |
| Address |
8010ArcoCorp.Drive, Suite 100,Raleigh, North Carolina 27617 USA, |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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| Name |
Address |
| PRA International |
The Qube, A-603, C.T.S.No.1498 A/2 M.V. Road, Marol, Andheri (East), Mumbai-400059, MAHARASHTRA India |
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Countries of Recruitment
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Austria
Belgium
China
Czech Republic
Germany
Hungary
Israel
Italy
Netherlands
Romania
Singapore
Spain
Taiwan
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Salvadeeswaran Meenakshi Sudaram |
Apollo Speciality Hospitals |
Lake View Road,K. K. Nagar,Madurai-625 020
Madurai
TAMIL NADU |
919842142999
drsundarsms@gmail.com |
| Dr Sita Jayalaskhmi |
Krishna Institute of Medical Sciences Ltd, |
1-8-31/1, Minister Road,500 003
Hyderabad
ANDHRA PRADESH |
919848019036
914027818844
sita_js@gmail.com |
| Dr. Rangashetty Srinivasa |
M.S.Ramaiah Memorial Hospital |
Gokula Metropolis Clinical Research Center,,MSRIT Post, New Bel Road-560 054
Bangalore
KARNATAKA |
91 80 22183125
91 8040528402
drrsrinivasa@hotmail.com |
| Dr Rahul Baviskar |
Neurocare |
Gajanan Avenue,
Near Old Nasik Mu nicipal Corporation,
Old Pandit Colony, 422002, India.
Nashik
MAHARASHTRA |
91-9820572480
91-253-2232660
rbaviskar@gmail.com |
| Dr. Roop kumar Gursahani |
PD Hinduja National Hospital and Medical Research Centre |
Department of Neurology, Room no. 2101,,Veer Savarkar Marg, Mahim (W)-400016
Mumbai
MAHARASHTRA |
91 22 24440425
91-99821087597
roop_gursahani@hotmail.com |
| Dr. Sangeetha Ravat |
Seth G. S. Medical College, K.E.M. Hospital |
Department of Neurology, ,Room No 223/224, 2nd Floor, Old Building, Parel, -400012
Mumbai
MAHARASHTRA |
91-9820310850
91-22-24164206
ravatsh@yahoo.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Apollo hospitals |
Approved |
| Clinical Research and Ethics committee |
Approved |
| Ethical Review Board |
Approved |
| Ethics committee for Research on Human subjects |
Approved |
| Institutional Ethics Committee- KIIMS |
Approved |
| Shatabdi Hospital Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Focal Epilepsy |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brivaracetam |
10mg, 25mg, 50 mg, 52 weeks, route of administration-oral |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subject completed the Treatment Period of N01358.
Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected.
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| ExclusionCriteria |
| Details |
Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study
Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
Poor compliance with the visit schedule or medication intake in the previous BRV study
Any medical condition which, in the Investigator?s opinion, warrants exclusion
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Method of Generating Random Sequence
Modification(s)
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Other |
Method of Concealment
Modification(s)
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Not Applicable |
Blinding/Masking
Modification(s)
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Not Applicable |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
The primary efficacy variable is the POS (type I) seizure frequency standardized to a 28-day
duration. |
This will be summarized by 3-month periods over the Evaluation Period. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective is to evaluate the maintenance of efficacy of
BRV over time. |
3 months |
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Target Sample Size
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Total Sample Size="900"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
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Phase 3 |
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Date of First Enrollment (India)
|
23/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/05/2011 |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
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NA |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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UCB is developing BRV(Brivaracetam) as an adjunctive antiepileptic treatment in subjects 16 years and older suffering from focal epilepsy. N01379 will give subjects who have completed N01358 the opportunity to access BRV (Brivaracetam) under the present protocol. N01358 is an adequate and well-controlled study to provide additional data confirming the efficacy and safety of BRV (Brivaracetam) as an AED (Anti Epiletic Drug) in adults (more than or equal to16 years) with refractory POS whether or not secondarily generalized. N01379 will explore the long-term safety and efficacy of BRV (Brivaracetam) in subjects with POS (Partial Onset Seizures) whether or not secondarily generalized while providing access to BRV (Brivaracetam) for subjects who may benefit from open-label treatment with BRV (Brivaracetam) . Study is globally in recruitment. In India recruitment has started.
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