| CTRI Number |
CTRI/2010/091/001194 [Registered on: 09/08/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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Clinical Study to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizures |
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Scientific Title of Study
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Clinical Study to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizures |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| EPL/2009/ESCBZ/01 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr Shripad Pujari |
| Designation |
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| Affiliation |
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| Address |
Noble Hospital
153, Magarpatta Road, Hadpsar
Pune
MAHARASHTRA
411013
India |
| Phone |
020 66285013 |
| Fax |
|
| Email |
drvaibhav25@rediffmail.com |
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Details of Contact Person
Scientific Query
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| Name |
Dr Sandeep Sonawane |
| Designation |
|
| Affiliation |
Emcure Pharmaceuticals Ltd. |
| Address |
Emcure Pharmaceuticals Ltd.
Survey No. 255/2, Hinjewadi,
Pune
MAHARASHTRA
411 057
India |
| Phone |
020 39821019 |
| Fax |
020 39821019 |
| Email |
Sandeep.Sonawane@emcure.co.in |
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Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Sonawane |
| Designation |
|
| Affiliation |
|
| Address |
Emcure Pharmaceuticals Ltd.
Survey No. 255/2, Hinjewadi,
Pune
MAHARASHTRA
411 057
India |
| Phone |
020 39821019 |
| Fax |
020 39821019 |
| Email |
Sandeep.Sonawane@emcure.co.in |
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Source of Monetary or Material Support
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| Emcure Pharmaceuticals Ltd., Pune |
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Primary Sponsor
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| Name |
Emcure Pharmaceuticals Ltd., Pune |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Baviskar |
Neuro care hospital, |
Rajee Enclave, near potoba hotel,New pandit colony,-422004
Nashik
MAHARASHTRA |
0253 3245275
rbaviskar@gmail.com |
| Dr K.K. Nirmal Raj |
Nirvaan Neuro Centre |
P.M. Road,,Talap,-670002
Kannur
KERALA |
0497 2712792
niral_raj53@yahoo.com |
| Dr Shripad Pujari |
Noble Hospital |
153, Magarpatta Road,,Hadpasar-411013
Pune
MAHARASHTRA |
020 66285013
drvaibhav25@rediffmail.com |
| Dr Sanjay Varade |
Sahyadri Hospital, |
Mumbai Agra Road,,Dwarka Circle-422001
Nashik
MAHARASHTRA |
0253 2597907
sanjayvarhade1@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Dhanashree Hospital for Dr K.K. Nirmal Raj |
Approved |
| Independent Ethics Committee, Dhanashree Hospital for Dr Rahul Baviskar |
Approved |
| Independent Ethics Committee, Dhanashree Hospital for Dr Sanjay Varade |
Approved |
| Noble Hospital institutional Ethics Committee for Dr Sanjay Pujari |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Partial-onset seizures, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Eslicarbazepine |
400 mg once daily (OD)for 12 weeks |
| Comparator Agent |
Oxcarbazepine |
300 mg BID (600 mg/day)for 12 weeks |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1.Male and Female subjects between 18 to 65 years of age.
2.Subjects diagnosed with simple or complex partial seizures with or without secondary generalization and taking stable doses of antiepileptic drugs for at least 2 weeks.
3.Subjects with at least 2 partial ? onset seizures per month OR 4 partial ? onset seizure in last 2 months in spite of treatment with following one to two (1-2) antiepileptic drugs: phenytoin, valproic acid, primidone, phenoparbital, lamotrigine, gabapentin, topiramate, clonazepam, carbamazepine and levetiracetam OR any other antiepileptic drugs except Eslicarbazepine/ oxcarbazepine.
4.Subject willing to give written informed consent and willing to comply with trial protocol
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| ExclusionCriteria |
| Details |
1.Subjects with primary generalized seizure.
2.Subjects with known progressive neurological disorder.
3.Subjects with episode of status epilepticus or cluster seizure within past 3 months.
4.Subjects with seizure of non-epileptic origin.
5.Subjects with major psychiatric illness or previous suicidal attempts.
6.Patients taking concurrent drug therapies with: Monoamine oxidase inhibitor (MAO), Calcium channel blockers (CCB), falbamate, diuretics, desmopressin, warfarrin, nefazodone and oxcarbazepine.
7.Known hypersensitivity to eslicarbazepine, carbamazepine, oxcarbazepine, tricyclic compounds OR known hypersensitivity to any constituent of the Test/ Reference formulation.
8.Subjects with cardiac arrhythmia or any abnormality on ECG.
9.Subjects with previous history of bone marrow depression.
10.Patients with significant hematological / metabolic / endocrinologial (excluding type 2 Diabetes Mellitus) / respiratory/cardiac/liver/kidney/psychiatric diseases
11.Pregnant and lactating mother.
12.Female of reproductive age and willing to become pregnant.
13.Female of reproductive age using steroidal/hormonal contraceptives.
14.Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug.
15.Patients with Alcohol or drug abuse.
16.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequency |
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks |
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Secondary Outcome
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| Outcome |
TimePoints |
| 1.Seizure frequency per 4 weeks
2.Number of days with seizure
3.Proportion of seizure free subjects
4.Proportion of subjects with an exacerbation in seizure frequency (≥ 25%)
5.Distribution of seizure reduction (proportion of subjects with seizure reduction of 50%; ≥ 50 ? 75% or > 75%)
6. Subjects? global assessment for efficacy
7. Physicians? global assessment for efficacy
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0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/08/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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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
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This is a openlabel, randomized, multi-center, phase III clinical trial conducted to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizures. A total of 200 patients will be enrolled in the study. All patients will receive either Eslicarbazepine acetate 400 mg tablet or Oxcarbazepine 300 mg tablet. For both the treatment groups, the starting dose will be lower strength. In subsequent visits dose may be titrated, if clinically required. All patients will be evaluated every two weeks for efficacy and safety variables during 3 months of therapy. The primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequency. The secondary efficacy variables will 1) Seizure frequency per 4 weeks; 2) Number of days with seizure; 3) Proportion of seizure free subjects 4) Proportion of patients with an exacerbation in seizure frequency (≥ 25%); 5) Distribution of seizure reduction (proportion of patients with seizure reduction of 50%; ≥ 50 ? 75% or > 75%); 6) Subjects? global assessment for efficacy; 7) Physicians? global assessment for efficacy. The safety variables will be Clinical: 1) Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator; 2) Subject?s global assessment about the tolerability of the drug; 3) Physician?s global assessment about the tolerability of the drug Investigational: Subjects will be evaluated for CBC (Complete Blood Count), LFT (Liver Function Test), KFT (Kidney Function Test) Lipid profile, FBG (Fasting Blood Glucose), and ECG (Electrocardiogram) |