A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Sponsor

UCB Biopharma S.P.R.L. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03250377

Collaborator

(none)

227

Enrollment

Locations

Arm

90.9

Anticipated Duration (Months)

3.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.

Condition or Disease	Intervention/Treatment	Phase
Partial Seizures With or Without Secondary Generalization Epilepsy	Drug: Brivaracetam	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

227 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Actual Study Start Date :

Aug 5, 2017

Anticipated Primary Completion Date :

Mar 3, 2025

Anticipated Study Completion Date :

Mar 3, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brivaracetam Subjects randomized to this arm will receive open-label Brivaracetam	Drug: Brivaracetam Pharmaceutical form: Film-coated tablet Concentration: 25 mg and 50 mg Route of administration: Oral use Other Names: Briviact

Arm

Intervention/Treatment

Experimental: Brivaracetam

Subjects randomized to this arm will receive open-label Brivaracetam

Drug: Brivaracetam

Pharmaceutical form: Film-coated tablet Concentration: 25 mg and 50 mg Route of administration: Oral use

Other Names:

Briviact

Outcome Measures

Primary Outcome Measures

Adverse Events (AEs) [From study entry until Final Visit (up to 70 months)]
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period [Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)]
The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). Change in seizure frequency from Baseline of EP0083 (NCT03083665) or N01358 (NCT01261325) is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of EP0083 or N01358.
Responder rate in partial seizure frequency per 28 days over the Evaluation Period [Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)]
The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). A responder is defined as a subject with a >= 50% reduction in seizure frequency from the Baseline Period of EP0083 or N01358.
Percentage of subjects continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period [During the Evaluation Period (up to 70 months)]
A subject was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
Percentage of subjects continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period [During the Evaluation Period (up to 70 months)]
A subject was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
Percentage of subjects continuously seizure-free for partial seizure and all seizure types during the Evaluation Period [During the Evaluation Period (up to 70 months)]
A subject was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male/female subject from 16 years of age or older. Subjects who are not legal adults may only be included where legally permitted and ethically accepted
Subject completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan
Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method

Exclusion Criteria:

Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study
Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
Poor compliance with the visit schedule or medication intake in the previous BRV studies
Planned participation in any other clinical study of another investigational drug or device during this study
Pregnant or lactating woman
Any medical condition which, in the Investigator's opinion, warrants exclusion
Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Subject has >2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert's syndrome)

Contacts and Locations

Locations

	Site	City	Country
1	Ep0085 905	Beijing	China
2	Ep0085 901	Chengdu	China
3	Ep0085 902	Guangzhou	China
4	Ep0085 909	Guangzhou	China
5	Ep0085 917	Guangzhou	China
6	Ep0085 920	Guangzhou	China
7	Ep0085 924	Guangzhou	China
8	Ep0085 912	Hangzhou	China
9	Ep0085 908	Lanzhou	China
10	Ep0085 921	Nanchang	China
11	Ep0085 926	Pingxiang	China
12	Ep0085 910	Shijiazhuang	China
13	Ep0085 925	Suzhou	China
14	Ep0085 913	Wenzhou	China
15	Ep0085 930	Xinxiang	China
16	Ep0085 916	Yinchuan	China
17	Ep0085 918	Zhanjiang	China
18	Ep0085 904	Zhengzhou	China
19	Ep0085 923	Zunyi	China
20	Ep0085 148	Adachi-ku	Japan
21	Ep0085 116	Asaka	Japan
22	Ep0085 126	Bunkyo-ku	Japan
23	Ep0085 127	Bunkyo-ku	Japan
24	Ep0085 122	Hachinohe	Japan
25	Ep0085 111	Hamamatsu	Japan
26	Ep0085 141	Higashisonogi-gun Kawatana-cho	Japan
27	Ep0085 110	Hiroshima	Japan
28	Ep0085 121	Itami	Japan
29	Ep0085 102	Kagoshima	Japan
30	Ep0085 142	Kamakura	Japan
31	Ep0085 140	Kawasaki	Japan
32	Ep0085 123	Kodaira	Japan
33	Ep0085 115	Kokubunji	Japan
34	Ep0085 132	Koriyama	Japan
35	Ep0085 112	Koshi	Japan
36	Ep0085 128	Kurume	Japan
37	Ep0085 124	Kyoto	Japan
38	Ep0085 147	Kyoto	Japan
39	Ep0085 105	Nagakute	Japan
40	Ep0085 118	Nagoya	Japan
41	Ep0085 136	Nagoya	Japan
42	Ep0085 117	Nara	Japan
43	Ep0085 129	Neyagawa	Japan
44	Ep0085 106	Niigata	Japan
45	Ep0085 850	Osaka	Japan
46	Ep0085 114	Saitama	Japan
47	Ep0085 101	Sapporo	Japan
48	Ep0085 103	Sendai	Japan
49	Ep0085 144	Shinjuku-ku	Japan
50	Ep0085 104	Shizuoka	Japan
51	Ep0085 108	Suita	Japan
52	Ep0085 137	Suita	Japan
53	Ep0085 138	Tsukuba	Japan
54	Ep0085 133	Ushiku	Japan
55	Ep0085 109	Yamagata	Japan
56	Ep0085 120	Yokohama	Japan
57	Ep0085 150	Yokohama	Japan
58	Ep0085 130	Ôsaka	Japan
59	Ep0085 131	Ōtsu	Japan