A multicenter, double-blind, randomized, placebo-controlled, 4 parallel groups, dose-ranging trial evaluating the efficacy and safety of ucb 34714 used as adjunctive treatment at doses of 50, 150 and 400 mg/day in b.i.d. administration (oral capsules of 25 or 50 mg) for a maximum of 13 weeks in subjects from 16 to 65 years with refractory epilepsy suffering from partial onset seizures whether or not secondarily generalized - ucb 34714 dose-ranging

Phase 1

• Conditions: Epilepsy - Refractory Partial Onset Seizure wheter or not secondarily generalized.; MedDRA version: 7.1Level: LLTClassification code 10061334

• Registration Number: EUCTR2004-001856-35-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: 2005-12-07
• Study Completion: 2006-03-28
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

•An IEC approved written informed consent signed and dated by the subject or by parent(s) or legal representative. The consent form or a specific assent form, where required, will be signed and dated by minors.
•Well-characterized focal epilepsy or epileptic syndrome according to the ILAE classification, which was supported by adequate diagnostic documentation (EEG and MRI/CT scan).
•Subjects with a history of partial onset seizures whether or not secondarily generalized.
•Subjects having at least 4 partial onset seizures whether or not secondarily generalized during the 4-week Baseline Period and at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1.
•Subjects being uncontrolled while treated by 1 or 2 concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will not be counted as a concomitant AED.
•Concomitant AED(s) being stable from at least 1 month before Visit 1 and during the whole trial period.
•Male/female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted.
•Female subjects without childbearing potential (2 years post-menopausal, 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 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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Seizure type IA non-motor as only seizure type.
•History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. < 20 minutes, with or without function regained between 2 ictal events during the last 5 years before V1.
•History or presence of status epilepticus during the last five years before V1.
•History or presence of known pseudo-seizures.
•Subjects on felbamate or having been on felbamate.
•Subjects currently on vigabatrine. Subjects having been on vigabatrine if no visual fields examination report available including standard static (Humphrey or Octopus) or cinetic perimetry (Goldman).
•Subject taking any drug with possible CNS effects. The use of benzodiazepine (BZD) is allowed if taken less than once a week. If taken more than once a week (for any indication), BZD will be considered as a concomitant AED.
•Subjects taking any drug that may significantly influence the metabolism of ucb 34714 (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been kept stable at least 1 month before V1, and will be kept stable during the entire trial duration.
•History of cerebrovascular accident (CVA), including transient ischemic attack (TIA), after which the subject’s condition had not stabilized and recurrence could not be excluded.
•Subjects suffering from severe cardiovascular disease.
•Presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (i.e. not expected to stay stable during trial participation) brain disorder or brain tumor. Stable arteriovenous malformations, meningiomas or other benign tumors may be acceptable with prior approval by UCB.
•Any clinical conditions (e.g. bone marrow depression, chronic hepatic disease and/or severe renal impairment) which may contraindicate the use of ucb 34714, impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
•Presence of terminal illness
•Presence of a serious infection.
•Subjects with history of severe adverse hematologic reaction to any drug.
•Subjects suffering from severe disturbance of haemostasis.
•Subjects suffering from severe hyperuricaemia.
•Presence of unstable hyperthyroidism.
•Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, ?GT value of more than three times the upper limit of the reference range.
•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).
•Clinically significant ECG abnormalities according to Investigator.
•History of suicide attempt, current suicidal ideation or other serious psychiatric disorders [i.e. bipolar disorder, severe depression (with hallucinations and illusions), psychosis] requiring or having required hospitalization or medication within the previous five years.
•Known allergic reaction or intolerance to pyrrolidine derivatives and/or investigational product excipients.
•Known multiple drug allergies or severe drug allergy.
•Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method.
•Subjects with a body weight less than 45 kg.
•Known alcohol or drug addiction or abuse within the last two years.
•Subject institutionalized under judicial decision.
•Subject taking part in another clinical/pharmacological trial in the three months preceding enrolmen

Study & Design

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