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

Not Applicable

Not yet recruiting

• Conditions: Health Condition 1: G40- Epilepsy and recurrent seizures

• Registration Number: CTRI/2018/07/014839
• Lead Sponsor: Glasshouse Pharmaceuticals Limited Canada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

5. 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.

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)

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