An open-label extension study of UCB0942 in adult patients with highly drug-resistant focal epilepsy.

Phase 1

• Conditions: highly drug-resistant focal epilepsy; MedDRA version: 18.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-001268-20-ES
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-30
• Study Completion: 2020-11-24
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
Subject must have completed V13 of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
? Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods.
Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom) AND that the respective partner will use an additional contraceptive method
Are the trial subjects under 18? no
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 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

Subject has active suicidal ideation as indicated by a positive response (?Yes?) to either Question 4 or Question 5 of the ?Since Last Visit? version of the Columbia Suicide Severity Rating Scale. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study
Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half lives whichever is longer) prior to study entry
? Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded:
- Prolonged QTc (Bazett?s, machine-read) interval defined as > 450 ms for males and > 470 ms for females
- Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval >= 220 ms)
- Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
- In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration.
Subject has a clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073

Study & Design

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