Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluatio

Phase 1

• Conditions: Epilepsy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004957-33-Outside-EU/EEA
• Lead Sponsor: Eisai Korea Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-13
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Epilepsy participants over 15 years old.
2. Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
3. Participants who have not taken antiepileptic drugs (AEDs) in recent 3 months.
4. For women of childbearing potential, the participant must have agreed to use contraception during the study period.
5. Participants who agree with Informed Consent Form.

Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participants who have Myoclonic seizures and/or Absence seizures.
2. Participants who have progressive central nervous system (CNS) disorder.
3. Participants who have serious systemic disorder.
4. Participants with serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) level more than twice the normal range or blood urea nitrogen (BUN)/Creatinine level more than 3 times the normal range.
5. Participants who have renal stones.
6. Medical history of medicinal poisoning and/or alcoholism.
7. Participants who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified