Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

Epilepsy Clinical Trial

— BRITE™  

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 Aged 16 Years or Older With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339559
• Other study ID #: N01379
• Secondary ID: 2010-020345-27
• Status: Completed
• Phase: Phase 3
• Start date: May 11, 2011
• Est. completion date: April 18, 2019

Study information

• Verified date: August 2021
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

Description:

The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: April 18, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Subject completed the Treatment Period of N01358 or the evaluation period of N01258

• Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted

• Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected

• Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

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 studies

• 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 study

• 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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Brivaracetam
Tablet, Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.

Locations

Country	Name	City	State
Austria	202	Innsbruck
Austria	201	Linz
Austria	203	Wien
Belgium	226	Hechtel-Eksel
Belgium	227	Leuven
Brazil	104	Belo Horizonte
Brazil	100	Florianopolis
Brazil	101	Sao Paulo
Bulgaria	294	Blagoevgrad
Bulgaria	286	Sofia
Bulgaria	287	Sofia
Canada	075	Calgary	Alberta
Canada	077	Greenfield Park	Quebec
Canada	078	London	Ontario
Canada	079	Montreal
Canada	080	Saskatoon	Saskatchewan
Canada	076	Toronto	Ontario
Czechia	917	Brno
Czechia	916	Kromeriz
Czechia	251	Ostrava
Czechia	256	Ostrava
Czechia	913	Ostrava Poruba
Czechia	252	Praha 1
Czechia	253	Praha 4
Czechia	250	Zlin
Estonia	650	Tallinn
Estonia	652	Tallinn
Estonia	651	Tartu
Finland	275	Kuopio
Finland	276	Tampere
France	301	Bethune
France	305	Montpellier
Germany	329	Berlin
Germany	326	Bernau
Germany	332	Bielefeld
Germany	902	Erlangen
Germany	331	Göttingen
Germany	327	Kiel
Germany	900	Marburg
Germany	335	Muenchen
Germany	334	Osnabruck
Germany	330	Ravensburg
Germany	328	Ulm
Hong Kong	700	Hong Kong
Hong Kong	701	Hong Kong
Hungary	410	Budapest
Hungary	411	Budapest
Hungary	412	Budapest
Hungary	414	Hajdú-Bihar
Hungary	413	Szekszard
India	726	Bangalore
India	727	Hyderabad
India	729	Madurai
India	725	Mumbai
India	728	Mumbai
India	731	Nashik	Maharashtra
Italy	378	Bari
Italy	380	Firenze
Italy	379	Milano
Italy	377	Monserrato
Italy	386	Napoli
Italy	376	Perugia
Italy	375	Pisa
Italy	383	Pozzilli
Italy	384	Reggio Calabria
Japan	855	Hiroshima
Japan	852	Itami	Hyogo
Japan	850	Osaka
Japan	851	Shizuoka
Japan	854	Yokohama-City
Korea, Republic of	753	Busan
Korea, Republic of	750	Seoul
Korea, Republic of	751	Seoul
Korea, Republic of	754	Seoul
Latvia	627	Daugavpils
Latvia	629	Jekabpils
Latvia	628	Riga
Latvia	625	Valmiera
Lithuania	425	Alytus
Lithuania	427	Kaunas
Lithuania	426	Vilnius
Mexico	129	Aguascalientes
Mexico	127	Culiacan
Mexico	125	Distrito Federal
Mexico	126	Guadalajara	Jalisco
Mexico	128	Guadalajara	Jalisco
Mexico	130	Mexico City
Netherlands	401	Heemstede
Netherlands	400	Heeze
Netherlands	403	Zwolle
Poland	475	Bialystok
Poland	485	Gdansk
Poland	791	Gdansk
Poland	478	Katowice
Poland	480	Katowice
Poland	481	Katowice
Poland	795	Katowice
Poland	476	Krakow
Poland	793	Krakow
Poland	483	Lublin
Poland	477	Poznan
Poland	479	Poznan
Poland	482	Poznan
Poland	488	Warszawa
Poland	794	Warszawa
Puerto Rico	038	San Juan
Russian Federation	501	Kazan
Russian Federation	506	Kazan
Russian Federation	502	Moscow
Russian Federation	503	Moscow
Russian Federation	509	Nizhny Novgorod
Russian Federation	508	Smolensk
Spain	528	Barcelona
Spain	529	Barcelona
Spain	535	Barcelona
Spain	540	Barcelona
Spain	539	San Sebastian
Spain	532	Santiago de Compostela
Spain	527	Valencia
Spain	537	Valencia
Spain	526	Valladolid
Sweden	551	Goteborg
Sweden	552	Linkoping
Sweden	550	Stockholm
Taiwan	806	Kaohsiung City
Taiwan	801	Taichung
Taiwan	800	Tainan
Taiwan	803	Taoyuan
United Kingdom	603	Birmingham
United Kingdom	600	London
United Kingdom	605	Middlesborough
United Kingdom	602	Morriston	Swansea
United Kingdom	607	Newcastle
United Kingdom	608	Salford
United Kingdom	601	Truro
United States	020	Ames	Iowa
United States	010	Asheville	North Carolina
United States	023	Atlanta	Georgia
United States	060	Aurora	Colorado
United States	061	Austin	Texas
United States	008	Bethesda	Maryland
United States	039	Boise	Idaho
United States	028	Charleston	South Carolina
United States	036	Charlottesville	Virginia
United States	029	Chicago	Illinois
United States	034	Cleveland	Ohio
United States	070	Columbus	Ohio
United States	778	Columbus	Ohio
United States	011	Dallas	Texas
United States	035	Dallas	Texas
United States	777	Dallas	Texas
United States	003	Durham	North Carolina
United States	009	Golden Valley	Minnesota
United States	042	Hamilton	New Jersey
United States	049	Houston	Texas
United States	069	Iowa City	Iowa
United States	032	Lebanon	New Hampshire
United States	780	Lexington	Kentucky
United States	775	Little Rock	Arkansas
United States	052	Madison	Wisconsin
United States	050	Mansfield	Texas
United States	071	Miami	Florida
United States	057	Milwaukee	Wisconsin
United States	776	Nashville	Tennessee
United States	022	New York	New York
United States	099	New York	New York
United States	043	Oklahoma City	Oklahoma
United States	091	Oklahoma City	Oklahoma
United States	027	Orlando	Florida
United States	005	Peoria	Illinois
United States	015	Philadelphia	Pennsylvania
United States	001	Phoenix	Arizona
United States	013	Phoenix	Arizona
United States	064	Port Charlotte	Florida
United States	021	Port Royal	South Carolina
United States	098	Poughkeepsie	New York
United States	048	Rome	Georgia
United States	025	San Francisco	California
United States	056	Spokane	Washington
United States	002	Toledo	Ohio
United States	006	Tucson	Arizona
United States	054	Tulsa	Oklahoma
United States	068	Waldorf	Maryland
United States	017	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
UCB BIOSCIENCES, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Estonia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Sweden,  Taiwan,  United Kingdom, 

References & Publications (1)

Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Jun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.	From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Primary	Percentage of Participants Who Withdrew Due to Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.	From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Primary	Percentage of Participants With at Least One Serious Adverse Event (SAE)	A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death; Is life-threatening; Requires in patient hospitalization or prolongation of existing hospitalization; Is a congenital anomaly or birth defect; Is as infection that requires treatment parenteral antibiotics; Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.	From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Secondary	Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period	The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.	From Baseline of the previous study until the Last Visit (up to 84 months)
Secondary	Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period	The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as: (the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.; Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.	From Baseline of the previous study until the Last Visit (up to 84 months)
Secondary	Responder Rate in POS (Type I) Frequency Over the Evaluation Period	A responder is defined as a subject with a = 50% reduction in seizure frequency from the Baseline Period of the previous study.; Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.	From Baseline of the previous study until the Last Visit (up to 84 months)

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