An open-label, multicenter, follow-up trial to evaluate long-term safety and efficacy ofucb 34714 used as adjunctive treatment at a flexible dose up to a maximum of 150 mg/day in subjects aged 16 years or older suffering from partial onset seizures

Phase 1

• Conditions: Epilepsy - refractory Partial Onset Seizure; MedDRA version: 8.0Level: LLTClassification code 10061334

• Registration Number: EUCTR2004-002140-10-ES
• Lead Sponsor: CB S.A. Pharma Sector

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

An Independent Ethic Committee (IEC) approved written informed consent signed
and dated by the subject or legally acceptable representative(s). The consent form or a specific assent form will be signed and dated by minors, according to country-specific regulations.
? Male/female subjects from 16 years or older. Subjects under 18 years may only be
included where legally permitted and ethically accepted.
? Inpatients or outpatients with partial onset seizures who were treated with ucb 34714 in previous trials / programs which allow access to the present trial.
?Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of ucb 34714 may be expected.
?Female subjects without childbearing potential (premenarcheal; 2 years post-menopausal; bilateral oophorectomy or ovariectomy; bilateral salpingectomy, complete hysterectomy; congenital sterility) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the trial participation (Intra Uterine Device; diaphragm with spermicide; male or female condom with spermicide; oral hormonal contraceptive; non- oral hormonal contraceptive medication; bilateral tubal ligation; monogamous relationship with vasectomized partner).
In particular, oral or depot contraceptive treatment with at least 30 µg [or 50 µg if associated with carbamazepine (CBZ)] ethinylestradiol per intake 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.
? Subject/legally acceptable representative considered as reliable and capable of
adhering to the protocol (e.g.; able to understand and complete diaries and
questionnaires), visit schedule or medication intake according to the judgment of the
Investigator
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Severe medical, neurological and psychiatric disorders, or laboratory values which
may have an impact on the safety of the subject.
? Subject having clinically significant deviations from reference range values for
laboratory parameters: creatinine clearance < 50 mL/min, platelets < 100,000/?l, or
neutrophil cells < 1,800/?l).
ucb 34714 / N01125 CONFIDENTIAL
Protocol RPCE03D0801 Final amended version / 01-Apr-2005 / Page 38 of 91 A
? Poor compliance with visit schedule or medication intake in previous ucb 34714 trial.
? Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, ?GT
value of more than three times the upper limit of the reference range.
? Participation in any clinical trial of another investigational drug or device during the
study.
If the Investigator has any medically valid reason to doubt the eligibility of a subject, the subject should not be included into the trial. If however, the Investigator has any other kind of doubts concerning the eligibility, he/she should consult the Sponsor’s CRP or representative for clarification.

Study & Design

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