An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

NCT ID: NCT02625090

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-03
• Study Completion Date: 2020-11-24

Brief Summary

The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be explored.

Detailed Description

For those subjects who benefit substantially from UCB0942 in the multicenter, randomized, double-blind, placebo-controlled, parallel group study EP0069, the current open-label extension study EP0073 will provide an opportunity to continue UCB0942 treatment after a careful evaluation of the individual benefit-risk balance and with close monitoring of safety, tolerability and efficacy of long-term study treatment.

Conditions

Highly Drug-resistant Focal Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UCB0942

UCB0942 400 mg bid or a tapered UCB0942 dose of 200 mg bid.

The Investigator will be allowed to increase or decrease the dose of UCB0942 to optimize tolerability and seizure control for each subject. Increases or decreases to the dose of UCB0942 should be made in steps not exceeding 200 mg/day per week; an exception is Taper Week 1 where a step of 800 mg/day to 500 mg/day is allowed. A faster decrease of the dose than 200 mg/day per week is allowed when it is clinically appropriate in the Investigator's medical judgment. Daily UCB0942 doses during this study may be 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid); intermediate doses will not be allowed except for tapering and titration unless agreed by the UCB Study Physician or PRA Medical Monitor. The dose of UCB0942 must always be administered as bid morning and evening doses, approximately 12 hours apart.

Group Type: EXPERIMENTAL

UCB0942

Intervention Type: DRUG

• Active Substance: UCB0942
• Pharmaceutical form: Film-coated tablet
• Concentration: 25 mg, 100 mg or 200 mg
• Route of Administration: oral

Interventions

UCB0942

• Active Substance: UCB0942
• Pharmaceutical form: Film-coated tablet
• Concentration: 25 mg, 100 mg or 200 mg
• Route of Administration: oral

Intervention Type: DRUG

Eligibility Criteria

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 Visit 13 (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

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:

1. Prolonged QTc (Bazett's, machine-read) interval defined as > 450 ms for males and > 470 ms for females

2. Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval >= 220 ms)

3. Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats

4. 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
• Upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome) at the EV (V2) of EP0073 (V15 of EP0069). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For enrolled subjects with a baseline result

• ULN for ALT, AST, ALP, or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening (ie, the value is
• ULN but <=2xULN at the EV [V2] of EP0073), repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

+1 844 599 2273 (UCB)

Locations

Ep0073 103

Brussels, , Belgium

Ep0073 101

Ghent, , Belgium

Ep0073 102

Leuven, , Belgium

Ep0073 201

Sofia, , Bulgaria

Ep0073 402

Bielefeld, , Germany

Ep0073 403

Radeberg, , Germany

Ep0073 405

Ravensburg, , Germany

Ep0073 601

Budapest, , Hungary

Ep0073 602

Budapest, , Hungary

Ep0073 302

Heeze, , Netherlands

Ep0073 502

Barcelona, , Spain

Ep0073 505

L'Hospitalet de Llobregat, , Spain

Ep0073 506

Madrid, , Spain

Ep0073 501

Seville, , Spain

Ep0073 503

Valencia, , Spain

Countries

Belgium; Bulgaria; Germany; Hungary; Netherlands; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-001268-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EP0073

Identifier Type: -

Identifier Source: org_study_id