Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

Epilepsy Clinical Trial

Official title:

An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175916
• Other study ID #: N01125
• Secondary ID: 2004-002140-10
• Status: Completed
• Phase: Phase 3
• Start date: September 2005
• Est. completion date: May 2019

Study information

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

Clinical Trial Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 853
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study

• Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study

• Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study

• Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected

Exclusion Criteria:

• Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject

• Poor compliance with visit schedule or medication intake in previous brivaracetam study

• Participation in any clinical study of another investigational drug or device during the study

• Pregnant or lactating woman

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Brivaracetam (ucb 34714)
10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry 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; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.

Locations

Country	Name	City	State
Austria	509	Graz
Austria	507	Innsbruck
Austria	510	Linz
Austria	508	Wien
Belgium	506	Brugge
Belgium	501	Edegem	Antwerpen
Belgium	513	Gent
Belgium	974	La Louvière
Belgium	505	Leuven
Belgium	515	Montignies sur Sambre	Chaleroi
Canada	950	Montreal	Quebec
Canada	952	Quebec
Canada	951	Vancouver	British Columbia
Czechia	545	Beroun
Czechia	543	Brno
Czechia	544	Brno
Czechia	546	Ceske Budejovice
Czechia	519	Ostrava Trebovice
Czechia	541	Praha 1
Czechia	517	Praha 2
Czechia	542	Praha 5
Czechia	518	Zlin
Finland	900	Helsinki
Finland	581	Kuopio
Finland	526	Oulu
Finland	582	Oulu
Finland	527	Seinajoki
Finland	583	Tampere
Finland	811	Tampere
France	632	Angers Cedex 1
France	628	Bethune
France	630	Dijon
France	624	Lille
France	633	Lyon	Bron
France	625	Marseille
France	623	Montpellier Cedex 5
France	635	Nancy
France	626	Paris
France	920	Paris
France	622	Rennes
France	528	Roanne
France	823	St Pierre Cedex
France	627	Strasbourg
France	634	Toulouse Cedex 04
Germany	532	Bad Berka
Germany	705	Berlin
Germany	708	Berlin
Germany	536	Bernau
Germany	707	Bielefeld
Germany	701	Bonn
Germany	709	Erlangen
Germany	703	Frankfurt
Germany	711	Freiburg
Germany	537	Göttingen
Germany	535	Jena
Germany	710	Kehl
Germany	531	Liegau-Augustusbad
Germany	533	Mainz
Germany	560	Munchen
Germany	706	Munchen
Germany	704	Ulm
Hong Kong	649	Hong Kong
Hong Kong	650	Shatin
Hungary	547	Budapest
Hungary	538	Debrecen
Hungary	539	Pecs
Israel	970	Tel Aviv
Italy	830	Bologna
Italy	553	Foggia
Italy	831	Messina
Italy	563	Milano
Italy	832	Milano
Italy	833	Napoli
Italy	554	Pavia
Italy	550	Perugia
Italy	552	Roma
Italy	555	Roma
Italy	559	Roma
Italy	973	Siena
Korea, Republic of	655	Gwangju
Korea, Republic of	652	Seoul
Korea, Republic of	653	Seoul
Korea, Republic of	654	Seoul
Korea, Republic of	656	Seoul
Netherlands	566	Breda
Netherlands	567	Den Haag
Netherlands	821	Heemstede
Netherlands	822	Heeze
Norway	571	Fredrikstad
Norway	568	Oslo
Norway	569	Sandvika
Norway	570	Trondheim
Poland	575	Bialystok
Poland	741	Gdansk
Poland	978	Grodzisk Mazowiecki
Poland	748	Katowice
Poland	976	Katowice
Poland	574	Kielce
Poland	975	Krakow
Poland	744	Lodz
Poland	747	Lodz
Poland	742	Lublin
Poland	977	Poznan
Poland	746	Szczecin
Poland	573	Warsaw
Poland	576	Warszawa
Poland	577	Warszawa
Poland	743	Warszawa
Poland	745	Warszawa
Russian Federation	591	Kazan
Russian Federation	578	Moscow
Russian Federation	579	Moscow
Russian Federation	584	Moscow
Russian Federation	586	Moscow
Russian Federation	588	Moscow
Russian Federation	943	Samara
Russian Federation	589	St. Petersburg
Russian Federation	587	Yaroslavl
Serbia	961	Belgrade
Serbia	962	Belgrade
Singapore	657	Singapore
South Africa	648	George
Spain	599	Alcorcón	Madrid
Spain	593	Barcelona
Spain	594	Madrid
Spain	783	Madrid
Spain	786	Madrid
Spain	596	San Sebastian
Spain	595	Vigo
Spain	597	Zaragoza
Sweden	850	Goteborg
Sweden	601	Stockholm
Sweden	604	Umea
Switzerland	605	Biel
Switzerland	607	St. Gallen
Switzerland	606	Tschugg
Switzerland	608	Zurich
Taiwan	671	Taichung
Taiwan	672	Taichung
Taiwan	669	Tainan
Taiwan	660	Taoyuan
Tunisia	861	Manouba
Tunisia	860	Tunis
Ukraine	638	Donetsk
Ukraine	637	Kharkov
Ukraine	641	Kyiv
Ukraine	642	Kyiv
Ukraine	639	Lviv
Ukraine	643	Odessa
Ukraine	640	Uzhgorod
United States	931	Charlottesville	Virginia
United States	933	Gainesville	Florida
United States	935	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Russian Federation,  Serbia,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Tunisia,  Ukraine, 

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 until Last Visit (up to 162 months)
Primary	Percentage of Participants Who Withdrew Due to an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant or trial participant 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 until Last Visit (up to 162 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 an 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 until Last Visit (up to 162 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.; Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].	From Entry Visit until Last Visit (up to 162 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.; Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].	From Entry Visit until Last Visit (up to 162 months)
Secondary	Responder Rate in POS (Type I) Frequency Over the Evaluation Period	A responder is defined as a participant with a = 50% reduction in seizure frequency from the Baseline Period of the previous study.; Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].	From Entry Visit until Last Visit (up to 162 months)

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