| CTRI Number |
CTRI/2010/091/001332 [Registered on: 18/10/2010] |
| Last Modified On: |
03/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures |
|
Scientific Title of Study
|
A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CBGG492A2211 |
Protocol Number |
| NCT01167335 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamala Rai |
| Designation |
|
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited, Medical Department,
Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022 -24958533 |
| Fax |
022 -24954112 |
| Email |
kamala.rai@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kamala Rai |
| Designation |
|
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited, Medical Department,
Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022 -24958533 |
| Fax |
022 -24954112 |
| Email |
kamala.rai@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Basel, Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Health care Private Limited |
| Address |
Sandoz House, 5th floor
Shivsagar Estate
Dr. Annie Besant Road
Worli, Mumbai 400 018
INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. J M K Murthy |
CARE Hospital |
Dept of Neurology, Exhibition Grounds Road,,Nampally,-500 001
Hyderabad
ANDHRA PRADESH |
9701700090
0091-40-66835559
jmkmurthy@satyam.net.in |
| Dr. Monika Singla |
Dayanand Medical College & Hospital |
Tagore Nagar Civil Lines,-141 001
Ludhiana
PUNJAB |
0161-4687320
0091-161-2308383
mbansal78@rediffmail.com |
| Dr. Rahul Kulkarni |
Deenanath Mangeshkar Hospital and Research Center |
Dept. of Neurology,Erandwane -411 004
Pune
MAHARASHTRA |
9822012588
0091-20-66023107
rahulneuro@gmail.com |
| Dr. Manmohan Mehdiratta |
G. B. Pant Hospital |
Dept of Neurology, Room No 502, ,Academic Block,-110 002
New Delhi
DELHI |
9718599303
0091-11-23234350
mmehndi@hotmail.com |
| Dr. Sita Jayalakshmi |
Krishna Institute of Medical Sciences |
1-8-31/1, Minister Road,,-500 003
|
9848019036
0091-40-27840980
sita_js@hotmail.com |
| Dr. Rangasetty Srinivasa |
M S Ramaiah Memorial Hospital , |
Department of Neurology ,,New BEL Road, MSRIT Post -560 054
Bangalore
KARNATAKA |
9448040589
0091-80-40528402
drrsrinivasa@hotmail.com |
| Dr. Shankar Nellikunja |
Mallikatta Neuro Centre |
Opp Mallikatta Circle,Kadri-575 002
Bangalore
KARNATAKA |
0824-2444933
0091-824-4255925
shankarmnl@hotmail.com |
| Dr. Bhawna Sharma |
Sawai Man Sing Hospital |
Dept of Neurology,,Jawaharlal Nehru Marg, -302 004
Jaipur
RAJASTHAN |
09414075120
0091-14-12570504
sharma.drbhawna@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Care Foundation, Hyderabad |
Submittted/Under Review |
| Dinanath Mangeshkar Hospital & Research Center, Pune |
Submittted/Under Review |
| Drug Trial Ethics Committee, Dayanand Medical College and Hospital, Ludhiana |
Submittted/Under Review |
| Ethical Review Board, Bangalore |
Submittted/Under Review |
| ETHICS Commitee, RMRS, SMS HOSPITAL (COLLEGE DEVELOPMENT FUND) JAIPUR |
Submittted/Under Review |
| Institutional Ethics Committee, Krishna Institute of Medical Sciences Limited, Secunderabad |
Approved |
| Mallikatta Ethical Committee, Mangalore |
Submittted/Under Review |
| MAMC Society for Promotion of Medical Research, New Delhi |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Partial Onset Seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BGG492 |
5 milligram |
| Intervention |
BGG492 |
50 milligram |
| Comparator Agent |
Placebo Comparator |
Placebo |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Male and female outpatients age 18 to 65 years (inclusive)
2. Weight of greater than or equal to 50 kg (110 lb)
3. Have a diagnosis of epilepsy (more than 2 years before screening) with partial seizures
with or without secondarily generalized seizures according to the International League
Against Epilepsys Classification of Epileptic Seizures (ILAE, 1981) Appendix 5
The Diagnosis should have been established by clinical history and electroencephalogram
(EEG) that is consistent with localization related epilepsy
4. Must have at least 4 partial seizures (defined as simple partial seizures with motor signs,
complex partial seizures, complex partial seizures with secondary generalization or a
combination of these types) during the 4 week baseline period and the 4 weeks
immediately preceding the baseline period
5. Have no 28day seizurefree period during the 8 weeks preceding randomization
6. Must have a positive test result for iGluR3 antibodies in the blood at screening. The mean
plus three standard deviations derived from healthy donors will be chosen as cutoff value.
7. Must have uncontrolled partial seizures despite having been treated with at least two
different antiepileptic drugs within the last 2 years prior to screening (given concurrently
or sequentially)
8. Must be receiving stable treatment (see inclusion criteria 8.1 to 8.4 and 9) with 1 or a
maximum of 2 AEDs from the list presented below:
8.1 No change in medication type, dose or frequency for 8 weeks prior to
randomization: Carbamazepine, Eslicarbazepine, Oxcarbazepine, Phenytoin,
Valproate, Lacosamide, Lamotrigine, Levetiracetam, Clobazam, Topiramate,
Zonisamide, Gabapentin and Pregabalin. Felbamate is only allowed, if treatment
has been continous for greater than or equal to 2 years.
8.2 No change in medication type, dose or frequency for 12 weeks prior to
randomization Phenobarbital and Primidone
8.3 Vagal nerve stimulation (VNS) will be counted as 1 AED. If using a vagal nerve
stimulator, the device must have been implanted for at least 5 months prior to
randomization. Stimulator parameters may not have been changed within 8 weeks
prior to randomization
8.4 Stable benzodiazepine treatment (no change in medication type, dose, or frequency
for 12 weeks prior to randomization) administered for e.g. epilepsy, anxiety, or
sleep disorders will be counted as one AED
Note: The use of intermittent benzodiazepines is defined in the exclusion criteria
2.5, refer to Section 4.2.
9. Must have had either a computed tomography (CT) or magnetic resonance imaging (MRI)
within the 5 years prior to screening that ruled out progressive neurological changes (e.g.
Alzheimer’s disease, Parkinson’s disease) in addition, no physical examination changes
suggestive of such lesions or diseases should have occurred since the imaging procedure
If a patient has not had a CT or MRI within the past 5 years, then a MRI must be
performed during the screening period and the results must be reviewed for compliance
with above criterion prior to randomization
10. Patients having had pre-surgical evaluations may be included. Also, patients having had
brain surgery for partial seizures may be included, if surgery was performed greater than or equal to 1 year
before randomization
11. Are on stable doses (constant for 4 weeks prior to randomization) of non AED
concomitant medication
Have a history of taking his/her medication(s) as directed (determined by direct
questioning of patient, caregiver and or investigator knowledge of prior compliance
problems if the patient had been under the investigators care prior to the study)
13. Are reliable and willing to make themselves available for the study period and are able to
record seizures and report adverse events themselves or have a caregiver (parent, legal
guardian) who can record and report the events for them
14. Have provided written informed consent before any assessments are performed. |
|
| ExclusionCriteria |
| Details |
* Presence of only non-motor simple partial seizures
* History of psychogenic seizures
* Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;
* Previous history of Lennox-Gastaut syndrome
*Pregnant or nursing (lactating) women
* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks |
12 weeks |
| Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.) |
10 weeks |
| Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period. |
28 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="57"
Sample Size from India="1"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Target number of patients from India is 30.
Planned FPFV from India is 11th November 2010.
No patients screened from India |