| CTRI Number |
CTRI/2018/07/014839 [Registered on: 12/07/2018] Trial Registered Prospectively |
| Last Modified On: |
19/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
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Type of Study
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| Study Design |
Randomized, Crossover Trial |
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Public Title of Study
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This is a study to compare two formulations of Felbamate in Eplileptic patients |
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Scientific Title of Study
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A Multi- Centre, randomized, open label, multiple dose, two treatment, two-way steady state cross over, bioequivalence study comparing Felbamate oral suspension 600mg/5 mL of Glasshouse Pharmaceutical Limited Canada to the Reference Listed Drug(RLD), Felbatol (Felbamate) oral suspension 600mg/5mL in adult male and non-pregnant female epilepsy patients under fasting condition. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| GPLC-FEL-01 Version 1.0, dated 04 Apr 2018 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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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
|
| Name |
Dr Gursimran Kaur |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
Plot No 12 / 2, 6th Floor , Vatika Mindscapes Tower – B, Sarai Khwaja Metro Station , NH- 2 , Mathura Road,
Sector 27 D
Faridabad
HARYANA
121003
India |
| Phone |
9899443314 |
| Fax |
1296613520 |
| Email |
Gursimran.kaur@jssresearch.com |
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Details of Contact Person
Public Query
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| Name |
Dr Shariq Anwar |
| Designation |
Head Operations - India |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
Plot No 12 / 2, 6th Floor , Vatika Mindscapes Tower – B, Sarai Khwaja Metro Station , NH- 2 , Mathura Road,
Sector 27 D,
Faridabad
HARYANA
121003
India |
| Phone |
9810979215 |
| Fax |
1296613520 |
| Email |
shariq.anwar@jssresearch.com |
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Source of Monetary or Material Support
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| Glasshouse Pharmaceuticals Limited Canada
2145 Meadowpine Blvd;
Mississauga,ON,L5N 6R8 (Canada) |
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Primary Sponsor
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| Name |
Glasshouse Pharmaceuticals Limited Canada |
| Address |
2145 Meadowpine Blvd;
Mississauga,ON,L5N 6R8 (Canada)
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| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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| Name |
Address |
| JSS Medical Research India Private Limited |
Plot No 12 / 2, 6th Floor , Vatika Mindscapes Tower – B,
Sarai Khwaja Metro Station , NH- 2 , Mathura Road,
Sector 27 D, Faridabad, Haryana – 121003, India
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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 Rajendra Someshwar Anand |
Kanoria Hospital and Research Centre |
Clinical Research Room Airport Gandhinagar Highway Village Bhat
Gandhinagar
GUJARAT |
9824017400
7923969452
drrajendraanand@yahoo.com |
| Dr Gunjkar Jaykumar Digambar |
Lifepoint Multispecialty Hospital |
3rd Floor, Clinical Research Department,
145/1,Mumbai Bangalore Higwhay,Near Hotel Sayaji,Wakad
Pune
MAHARASHTRA |
9767092120
02066434300
Gunjkar.jaykumar118@gmail.com |
| Dr Jain Praveen Harawat |
Medipoint Hospital Pvt Ltd |
3rd Floor Clinical research Department,Medipoint Clinic Building, 241/1, New D.P Road, Aundh
Pune
MAHARASHTRA |
9860526808
2027298081
praveenjain1969@gmail.com |
| Dr Amit Bhalchandra Yeole |
Supe Heart And Diabetes Hospital And Research Center |
Supe Heart And Diabetes Hospital And Research Center,1st Floor Clinical Research Department, Opp Adhar Asharm, Gharpureghat,Near Rungtha HighSchool, Ashok Stambh
Nashik
MAHARASHTRA |
9819651753
02532232487
amit_yeole37@rediffmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Kanoria Ethics Committee, Kanoria Hospital & Research Centre |
Submittted/Under Review |
| Lifepoint Research Ethics Committee, Lifepoint Multispeciality Hospital Pvt. Ltd. |
Approved |
| Penta-Med Ethics Committee, C/0 Medipoint Hospital Pvt. Ltd. |
Approved |
| Supe Hospital Ethics Committee, Supe Heart & Diabetes Hospital & Research Center |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G40||Epilepsy and recurrent seizures, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Felbamate Oral Suspension |
Felbamate Oral Suspension 600mg/5mL (Glasshouse pharmaceuticals); Dose- 1800 to 3600 mg/day to be given three times daily for a duration of 57-78 days |
| Comparator Agent |
Felbatol |
Felbamate Oral Suspension 600mg/5mL (MEDA Pharmaceuticals);Dose- 1800 to 3600 mg/day to be given three times daily for a duration of 57-78 days |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and Non Lactating , Non -Pregnant Female patients aged between 18-65years
2.Body Mass Index in the range of 18 – 30 kg/m2.
3.Patients diagnosed with Epilepsy who do not respond adequately to alternative treatment.
4.Patients must provide written Informed consent prior to any study related procedures being performed.
5. Patients must have a willingness and ability to comply with the protocol requirements
6. patients should not have clinically serious conditions as per Investigator’s discretion as determined by physical examination, medical history and routine hematological and Biochemical tests.
7. patients agreeing to, not using or conforming to not having any medication (prescription and over the counter, herbal products), including vitamins and minerals for 15 days prior to study entry (screening) and during the course of the study except any one of Valproic acid, Gabapentin, Levetiracetam or Pregabalin for ongoing therapy of their illness.
8.Female patients of Childbearing potential, in addition to having a negative serum Pregnancy test, must be willing to use a reliable means of contraception (other hormonal contraceptives) eg: barrier method (diaphragm or condom with spermicide, jellies, foams, intrauterine device(IUD),etc), surgical sterilization (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or abstinence for the duration of the study. Hormonal contraceptives should be avoided within 2 months prior to study entry (screening) |
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| ExclusionCriteria |
| Details |
1.History of allergic reactions to felbamate and/or related drugs
2.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia or idiopathic Parkinson’s disease
3.Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
4.Change in AED regimen in the last 28 days
5.Subject is currently taking > 3 concomitant AEDs
6.Subject has had status epilepticus within the past 2 years
7.Epilepsy dietary therapy initiated < 3 months prior to enrollment
8.Epilepsy surgery < 1 year prior to enrollment
9.A two-fold increase in the highest, 2-day pre-study seizure frequency
10.Single generalized, tonic-clonic seizure, if none occurred during pre-treatment screening, and/or,
11. Significant prolongation of generalized, tonic-clonic seizures
12.Red Blood Cells (RBCs), White Blood Cells (WBCs) and platelet counts below the lower limit of normal for the laboratory conducting the test and / or as per Investigator’s discretion
13.History of aplastic anemia or bone marrow suppression
14.Medical or surgical condition interfering with absorption, metabolism or excretion of felbamate
15.Serum transaminases > 2 multiply the upper limit of normal or history or evidence of hepatic dysfunction
16.Concurrent use of drugs known to suppress bone marrow function
17.Expected change of concomitant medications during trial
18.A history of severe hepatic impairment, drug inducted leucopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias and myocardial infarction or unstable heart disease
19.History of alcohol dependence, alcohol abuse or drug abuse within the past 6 months. Recent or current alcohol abuse (> 5 units/week, 1 unit equal to 10 mL or 8 gm of pure alcohol) or suspected abuse.
20.Patients with positive HIV I/II, HCV tests
21.Patients with positive HBsAg, positive anti-Hbc and positive anti HBs
22.Participation in any other clinical study within 90 days prior to Compliance with outpatient medication schedule not expected.
23.History of or currently active malignancy or any other serious diseases
24.Any contraindication to blood sampling
25.Blood donation within 90 days prior to the commencement of the study
26.Patients who are unable to fulfill study requirements in relation to conforming to the visit schedule.
27.Onset of screening period
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Bioavailability of Oral suspension of Glasshouse pharmaceuticals limited Canada’s felbamate relative to that of Felbatol |
Day 1 to Day 14 |
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Secondary Outcome
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| Outcome |
TimePoints |
Adverse Events,
Drug related Adverse events
Clinically significant changes in vital signs, Physical and Laboratory examination and ECG |
Throughout study |
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Target Sample Size
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Total Sample Size="28"
Sample Size from India="28"
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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N/A |
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Date of First Enrollment (India)
|
01/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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None Yet |
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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 study is a Randomized, open label, Multiple dose , Two Treatment , Two-way crossover, steady state , Bioequivalence study comparing Felbamate Oral suspension 600 mg / 5mL of Glasshouse pharmaceuticals limited Canada to Felbatol (Felbamate) oral suspension 600mg/5mL of MEDA pharmaceuticals in 28 patients who have been on established maintenance therapy with Felbamate for the treatment of epilepsy for at least two weeks prior to dosing. Study will be conducted in four centers in India |