This is a study to compare two formulations of Felbamate in Eplileptic patients

Not yet recruiting

Conditions: Epilepsy and recurrent seizures,

Registration Number: CTRI/2018/07/014839

Lead Sponsor: Glasshouse Pharmaceuticals Limited Canada

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 28

Inclusion Criteria

1.Male and Non Lactating , Non -Pregnant Female patients aged between 18-65years 2.Body Mass Index in the range of 18 â€“ 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.
Patients must have a willingness and ability to comply with the protocol requirements 6.
patients should not have clinically serious conditions as per Investigatorâ€™s discretion as determined by physical examination, medical history and routine hematological and Biochemical tests.
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.

Exclusion Criteria

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 Parkinsonâ€™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 Investigatorâ€™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.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioavailability of Oral suspension of Glasshouse pharmaceuticals limited Canadaâ€™s felbamate relative to that of Felbatol	Day 1 to Day 14

Secondary Outcome Measures

Name	Time	Method
Adverse Events,	Drug related Adverse events

Trial Locations

Locations (4): Kanoria Hospital and Research Centre
🇮🇳
Gandhinagar, GUJARAT, India
Lifepoint Multispecialty Hospital
🇮🇳
Pune, MAHARASHTRA, India
Medipoint Hospital Pvt Ltd
🇮🇳
Pune, MAHARASHTRA, India
Supe Heart And Diabetes Hospital And Research Center
🇮🇳
Nashik, MAHARASHTRA, India
Kanoria Hospital and Research Centre
🇮🇳Gandhinagar, GUJARAT, India
Dr Rajendra Someshwar Anand
Principal investigator
9824017400
drrajendraanand@yahoo.com