This study is designed to assess the safety and efficacy of an anti-epileptic drug, Brivaracetam in offering relief to adult patients suffering from a particular type of epilepsy or fits (partial onset seizures)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2011/08/001972
• Date of registration: 29-08-2011
• Prospective Registration: No
• Primary sponsor: SCHWARZ BIOSCIENCES INCA Member of the UCB Group of Companies
• Public title: This study is designed to assess the safety and efficacy of an anti-epileptic drug, Brivaracetam in offering relief to adult patients suffering from a particular type of epilepsy or fits (partial onset seizures)
• Scientific title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, Parallel Group Study To Evaluate the Efficacy and Safety of Brivaracetam in Subjects (16 To 80 Years Old) With Partial Onset Seizures
• Date of first enrolment: 16-05-2011
• Target sample size: 720
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2520
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Brazil, Canada, China, Czech Republic, India, Italy, Mexico, Netherlands, Poland, Republic of Korea, Russian Federation, Spain, Sweden, Taiwan, Ukraine, United States of America

Contacts

• Name: Dr Aparna Parikh
• Affiliation: Pharmaceutical Research Associates India Pvt. Ltd

• Name: Jigar Lakhani
• Affiliation: Pharmaceutical Research Associates India Pvt. Ltd

Key inclusion & exclusion criteria

Inclusion criteria: To be eligible to participate in this study, all of the following criteria must be met:

1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent form is signed and dated by the subject or by the parent(s) or legal representative. The consent form or a specific assent form, where required, will be signed and dated by minors.

2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.

3. Subjects (male or female) from 16 to 80 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted.

4. Subjects with a body weight ≥40kg.

5. Female subjects without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least 30μg ethinylestradiol per intake [or 50μg ethinylestradiol per intake if associated with any strong enzyme inducer (eg carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John?s Wort, rifampicin)], monogamous relationship with vasectomized partner, or double-barrier contraception are acceptable methods. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status.Abstinence will be considered as an acceptable method ofcontraception if the Investigator can document that the subject agrees to be compliant.

6. Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification.

7. Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years.

8. Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years.

9. Subjects having at least 8 Type I seizures [POS; focal seizures (according to the 1981

ILAE classification)] during the 8-week Baseline Period with at least 2 Type I seizures

during each 4-week interval of the Baseline Period.

10. Subjects having at least 2 partial onset seizures whether or not secondarily generalized

per month during the 3 months preceding V1.

11. Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal

Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED.

12. Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the

subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone)

before V1 and expected to be kept stable during the Baseline and Treatment Period.

Benzodiazepine taken more than once a week (for any indication) will be considered as a

concomitant AED.


Exclusion criteria: Subject previously randomized within this study or any other prior study with BRV as a dosing arm.

Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.

Subject has participated in another study of an investigational medication (or a medical device) within the last 30 days or is currently participating in another study of an investigational medication (or a medical device).

Subject is currently treated with LEV.

Subject has taken LEV within 90 days prior to V1.

Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject?s ability to participate in this study.

Subject has a known hypersensitivity to any components of the investigational medicinal product or comparative drugs as stated in this protocol.

Subject not able to read and understand the informed consent form, assent form, or seizure diary card instructions.

Subject has obvious cognitive impairment or mental retardation as per Investigator assessment.

Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries).

Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline.

Subject has history or presence of known psychogenic nonepileptic seizures.

Subject on felbamate with less than 18 months exposure before V1.

Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal.

Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period.

Subject taking any drug that may significantly influence the metabolism of BRV cytochrome P450 (potent inducers) except if the dose has been kept stable at least 1 month before V1, and is expected to be kept stable during the Treatment Period.

Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 6 months.

Subject is suffering from severe cardiovascular disease or peripheral vascular disease

Subject has presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (ie, not expected to stay stable during study participation) brain disorder or brain tumor. Stable arteriovenous malformations, meningiomas, or other benign tumors may be acceptable.

Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic disease, and/or severe renal impairment) which impair reliable participation in the study or necessitate the use of medication not allowed by protocol.

Subject has presence of a terminal illness.

Subject has presence of a serious infection.

Subject has history of severe adverse hematologic reaction to any drug.

Subject is suffering from severe disturbance of hemostasis.

Subject has impaired hepatic function: ALT/SGPT (alanine aminotransferase/serum glutamic pyruvate transaminase), AST/SGOT (aspartate aminotransferase/serum glutamic oxaloacetic transaminase), alkaline phosphatase of more than 2 times the upper limit of the reference range.

Gamma-glutamyltransferase (GGT)

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- "epilepsy; partial onset seizures"

Intervention(s)

Intervention1: Brivaracetam (BRV).: 10mg, 25mg, 50 mg. Dose duration of 16 weeks, rote of administration-Oral
Control Intervention1: Placebo: 10mg, 25mg, 50 mg. Dose duration of 16 weeks, route of administration-oral.

Primary Outcome(s)

To evaluate the efficacy of BRV at varies doses compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant AEDsTimepoint: 12 weeks

Secondary Outcome(s)

Percent reduction in partial onset seizure (Type I) frequency from the Baseline to the Treatment Period

Categorized percent reduction form Baseline in seizure frequency for partial onset seizure (Type I) over the Treatment Period

Seizure freedom rate (all seizure types) during the 12-week Treatment Period

Time to the first Type I seizure during the Treatment Period

Time to the fifth Type I seizure during the Treatment Period

Time to the tenth Type I seizure during the Treatment PeriodTimepoint: 12 weeks

Secondary ID(s)

NCT01261325

N01358

Source(s) of Monetary Support

UCB Pharma Alfred-Nobel-Straße 10, 40789 Monheim, Germany,

Secondary Sponsor(s)

PRA International

Ethics review

Status: Approved
Approval date: 11/04/2011
Contact:

Institutional Ethics Committee

Status: Approved
Approval date: 20/04/2011
Contact:

Clinical Research and Ethics Committee

Status: Approved
Approval date: 30/04/2011
Contact:

Institutional Ethics Committee-KIIMS

Status: Approved
Approval date: 09/05/2011
Contact:

Ethics Committee For Research On Human Subjects- KEM

Status: Approved
Approval date: 20/05/2011
Contact:

Ethical review Board-M.S. Ramaiah Medical College & teaching Hospital

Status: Approved
Approval date: 28/05/2011
Contact:

Apollo Hospitals