A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

NCT02495844 | Completed Phase 2 Results

• 2 other identifiers: EP00692014-003330-12
• Study Type: interventional
• Target: 55
• Locations: 6 countries
• Sites: 18

Brief Summary

This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.

Conditions

Highly Drug-resistant Focal Epilepsy

Keywords

UCB0942; Treatment-resistant focal epilepsy; Partial seizures; Seizure therapy

Outcome Measures

Primary Outcomes (1)

• 75 % Responder Rate During the 2-week Inpatient Period

  The 75% responder rate is defined as the percentage of subjects with a 75 % or greater reduction in focal seizure frequency during the 2-week Inpatient Period compared with the Baseline Period.

  During the 2-week Inpatient Period

Secondary Outcomes (12)

• Median Percent Change in Weekly Focal Seizure Frequency During the 2-week Inpatient Period

  During the 2-week Inpatient Period

• Median Percent Change in Weekly Focal Seizure Frequency During the Outpatient Maintenance Period

  During the Outpatient Maintenance Period (8 weeks)

• Median Percent Change in Weekly Focal Seizure Frequency During the On-UCB0942 Overall Period

  During the On-UCB0942 Overall Period (approximately 11 weeks)

• Seizure-free Rate (All Seizures) During the 2-week Inpatient Period

  During the 2-week Inpatient Period

• Seizure-free Rate (All Seizures) During the Last 4 Weeks of the Outpatient Maintenance Period

  During the last 4 weeks of the Outpatient Maintenance Period

Study Arms (2)

UCB0942

EXPERIMENTAL

UCB0942/UCB0942

Drug: UCB0942

Placebo

PLACEBO COMPARATOR

Placebo/UCB0942 (after 2-week inpatient period, placebo subjects will receive the experimental medicine, UCB0942).

Drug: UCB0942; Drug: Placebo

Interventions

UCB0942 DRUG

Active substance: UCB0942 Pharmaceutical form: Film-coated tablet Concentration: 200 mg Route of Administration: Oral use

UCB0942

Placebo DRUG

Pharmaceutical form: Film-coated tablet Route of administration: Oral use

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is an adult (18 years of age or more)
• Subject is able to understand the study and the ICF as assessed by the Investigator. Subjects with known mental retardation (defined as IQ below 70) are not eligible to participate. Subject and/or caregiver is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and the medication intake scheme as instructed according to the judgment of the Investigator
• Subject fulfills ILAE (1989) criteria for focal epilepsy; clinical semiology should be described and fulfill criteria for focal seizures; there will have been an electroencephalogram (EEG) reading compatible with focal epilepsy in the last 5 years; the subject has no seizures that are not focal by the new ILAE criteria; a brain MRI (magnetic resonance imaging) or head CT (computed tomography) to be performed before randomization, if no such scan was performed in the last 5 years, and a report is available. If a scan was performed within the last 5 years but the epilepsy has not been stable since the last scan, a new scan should be obtained
• Subject has failed to achieve seizure control with ≥4 appropriately chosen Antiepileptic Drug (AED) regimens of adequate dose and duration, including the current treatment, as documented in medical records and per Investigator assessment of patient report
• Subject is currently treated with a stable dose of at least 1 AED for the 4 weeks prior to the Screening Visit (Visit 1) and throughout the duration of the Treatment Period with or without additional concurrent vagus nerve stimulation (VNS) or other neurostimulation treatments. The VNS must have been in place for at least 12 months with constant settings for at least 3 months and the battery life of unit anticipated to extend for the duration of study prior to the Screening Visit and throughout the duration of the study
• During the 4 weeks prior to Screening (Historical Baseline Period), subject must report to have had an average of at least 4 spontaneous and observable focal seizures per week ("focal seizures" refers to partial-onset seizures of type IA1, IB, and IC, but does not include type IA2, IA3, or IA4 seizures), and cannot have had any seizure-free period longer than 3 days (based on Investigator assessment of subject report and seizure diaries if available). The cut-off seizure frequency (4 seizures per week) and maximum seizure-free interval (3 days) must be maintained during the 2-week Prospective Outpatient Baseline Period
• 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. Oral or depot contraceptive treatment with at least ethinylestradiol 30 μg per intake used with an additional barrier contraception method, monogamous relationship with vasectomized or female partner, 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. Abstinence will be considered as an acceptable method of contraception if the Investigator can document that the subject agrees to be compliant when it is in line with the preferred and usual lifestyle of the subject
• Male subjects confirm 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

You may not qualify if:

• Subject has participated in another study of an investigational medication (or medical device) within the last 30 days or is currently participating in another study of an investigational medication (or a medical device)
• Subject has a known hypersensitivity to any components of UCB0942 formulation or to similar drugs (LEV, BRV, or benzodiazepines), or a history of drug or other allergy that, in the opinion of the Investigator or UCB Study Physician, contraindicates her/his participation
• Subject has taken other (non-AED) prescription, nonprescription, 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 the Baseline Visit
• Subject is currently treated with carbamazepine, phenytoin, primidone, or phenobarbital or any other drug known to induce CYP3A4 liver enzymes; Subject is taking tiagabine, felbamate, or vigabatrin; Subject is taking benzodiazepines, zolpidem, zaleplon, or zopiclone \>3 times per week for any indication
• Subject has a clinically significant abnormality on echocardiography at Screening or a history of rheumatic heart disease or other known valvular abnormalities
• Subjects with a history of hypersensitivity reactions or autoimmune disease
• Female subject who is pregnant or breastfeeding

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead
• PRA Health Sciences: collaborator

Study Sites (18)

Ep0069 103

Brussels, Belgium

Location

Ep0069 101

Ghent, Belgium

Location

Ep0069 102

Leuven, Belgium

Location

Ep0069 201

Sofia, Bulgaria

Location

Ep0069 402

Bielefeld, Germany

Location

Ep0069 408

Hamburg, Germany

Location

Ep0069 401

Kehlkork, Germany

Location

Ep0069 407

Marburg, Germany

Location

Ep0069 403

Radeberg, Germany

Location

Ep0069 405

Ravensburg, Germany

Location

Ep0069 601

Budapest, Hungary

Location

Ep0069 602

Budapest, Hungary

Location

Ep0069 302

Heeze, Netherlands

Location

Ep0069 502

Barcelona, Spain

Location

Ep0069 505

Llobregat, Spain

Location

Ep0069 506

Madrid, Spain

Location

Ep0069 501

Seville, Spain

Location

Ep0069 503

Valencia, Spain

Location

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844599

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 13, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2019-02

Locations

BU (1); DE (6); NL (1); BE (3); ES (5); HU (2)