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

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2015-001268-20-NL
• Date of registration: 23/07/2015
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SRL
• Public title: An open-label extension study of UCB0942 in adult patients with highly drug-resistant focal epilepsy.
• Scientific title: AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF UCB0942 WHEN USED AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES IN ADULT SUBJECTS WITH HIGHLY DRUG-RESISTANT FOCAL EPILEPSY
• Date of first enrolment: 13/08/2015
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001268-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United States

Contacts

• Name: CT Registries & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: CT Registries & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

Key inclusion & exclusion 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 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).

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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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:
a) Prolonged QTc (Bazett's, machine-read) interval defined as > 450 ms for males and > 470 ms for females
b) Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval >= 220 ms)
c) Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
d) 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

highly drug-resistant focal epilepsy
MedDRA version: 21.1 Level: LLT Classification code 10065337 Term: Focal epilepsy System Organ Class: 100000004852

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Code: UCB0942
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available yet
CAS Number: 1294000-61-5
Current Sponsor code: UCB0942
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Product Name: UCB0942
Product Code: UCB0942
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not yet available
CAS Number: 1294000-61-5
Current Sponsor code: UCB0942
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: UCB0942
Product Code: UCB0942
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not yet available
CAS Number: 1294000-61-5
Current Sponsor code: UCB0942
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s): • The 75% Responder Rate at the end of the Evaluation Period
• Percentage of subjects with at least one treatment-emergent Adverse Events during the EP0073 study
• Percentage of subjects with at least one Serious Adverse Event during the EP0073 study
• Percentage of subjects discontinued due to treatment-emergent Adverse Events during the EP0073 study

Secondary Objective: • To evaluate the long-term efficacy of UCB0942
• To evaluate the effects of UCB0942 on the subject’s quality of life.

Main Objective: To evaluate the long-term safety and tolerability of UCB0942 at individualized doses between 100mg/day to a maximum of 800mg/day in subjects with highly drug-resistant focal epilepsy.

Timepoint(s) of evaluation of this end point: 58 months

Secondary Outcome(s)

Secondary end point(s): • Median partial-onset seizure frequency per 28 days over the Evaluation Period of the EP0073 study
• Median partial-onset seizure frequency per 28 days by seizure type over the Evaluation Period of the EP0073 study
• Percent reduction in partial-onset seizure frequency relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069 over the Evaluation Period of the EP0073 study
• The 50 % responder rate over the Evaluation Period of the EP0073 study
• Percentage of seizure-free days over the Evaluation Period
• Seizure-free rate over the Evaluation Period
• Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) scores from Visit 3 (Week 2) of EP0069 through the assessment of the Evaluation Period

Timepoint(s) of evaluation of this end point: 58 months

Secondary ID(s)

EP0073

Source(s) of Monetary Support

UCB Biopharma SRL

Ethics review

Status: Approved
Approval date: 13/08/2015
Contact: