This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

Epilepsy Clinical Trial

Official title:

An Open-label, Multi-center, 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: NCT00150800
• Other study ID #: N01199
• Status: Completed
• Phase: Phase 3
• Start date: January 2006
• Est. completion date: September 2017

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 provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Description:

Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 668
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted

• Subjects with epilepsy who have participated in previous brivaracetam trials 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

• Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study

• Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator

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 the visit schedule or medication intake in the previous brivaracetam study

• Pregnant or lactating women

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Brivaracetam
Active Substance: Brivaracetam Pharmaceutical Form: Tablet Concentration: 10 mg and 25 mg Route of Administration: Oral

Locations

Country	Name	City	State
Australia	N01199 1423	Adelaide	South Australia
Australia	N01199 1420	Chatswood	New South Wales
Australia	N01199 1427	Clayton	Victoria
Australia	N01199 1422	Fitzroy
Australia	N01199 1426	Parkville	Victoria
Australia	N01199 1430	Randwick	New South Wales
Australia	N01199 1421	West Heidelberg	Victoria
Australia	N01199 1428	Woodville	South Australia
Brazil	N01199 1028	Campinas
Brazil	N01199 1325	Curitiba
Brazil	N01199 1024	Florianopolis
Brazil	N01199 1150	Florianópolis
Brazil	N01199 1331	Porto Alegre
Brazil	N01199 1332	Porto Alegre
Brazil	N01199 1022	Riberao Preto
Brazil	N01199 1023	Salvador
Brazil	N01199 1029	São José do Rio Preto
Brazil	N01199 1021	Sao Paulo
Brazil	N01199 1027	Sao Paulo
Brazil	N01199 1030	Sao Paulo
Brazil	N01199 1326	Sao Paulo
Canada	N01199 1316	Edmonton	Alberta
Canada	N01199 1312	Greenfield Park	Quebec
Canada	N01199 1311	Montreal	Quebec
Canada	N01199 1314	Montreal	Quebec
Canada	N01199 1313	Quebec City	Quebec
India	N01199 1045	Bangalore
India	N01199 1256	Bangalore
India	N01199 1257	Bangalore
India	N01199 1261	Bangalore
India	N01199 1046	Chennai
India	N01199 1042	Hyderabad
India	N01199 1253	Hyderabad
India	N01199 1262	Hyderabad
India	N01199 1258	Jaipur
India	N01199 1040	Lucknow
India	N01199 1250	Lucknow
India	N01199 1043	Mumbai
India	N01199 1259	Mumbai
India	N01199 1266	Mumbai	Maharashti
India	N01199 1265	Parel Mumbai
India	N01199 1251	Pune
India	N01199 1264	Pune Maharashtra
India	N01199 1263	Tirupati
Mexico	N01199 1010	Aguascalientes
Mexico	N01199 1008	Chihuahua
Mexico	N01199 1009	Chihuahua
Mexico	N01199 1003	Guadalajara
Mexico	N01199 1403	Mexico City
Mexico	N01199 1005	Monterrey
Mexico	N01199 1007	Monterrey
Mexico	N01199 1002	San Luis Potosi
Mexico	N01199 1412	San Nicholas De Los Garza	Nuevo Leon
Mexico	N01199 1001	Zapopan
United States	N01199 1396	Atlanta	Georgia
United States	N01199 1385	Augusta	Georgia
United States	N01199 1373	Baltimore	Maryland
United States	N01199 1086	Bethesda	Maryland
United States	N01199 1077	Burlington	Massachusetts
United States	N01199 1367	Charlottesville	Virginia
United States	N01199 1360	Chesterfield	Missouri
United States	N01199 1356	Chicago	Illinois
United States	N01199 1366	Cincinnati	Ohio
United States	N01199 1054	Columbus	Ohio
United States	N01199 1084	Dallas	Texas
United States	N01199 1394	Dallas	Texas
United States	N01199 1391	Detroit	Michigan
United States	N01199 1395	Detroit	Michigan
United States	N01199 1078	Fresno	California
United States	N01199 1071	Grand Rapids	Michigan
United States	N01199 1069	Great Falls	Montana
United States	N01199 1081	Greenville	South Carolina
United States	N01199 1064	Houston	Texas
United States	N01199 1364	Lexington	Kentucky
United States	N01199 1050	Little Rock	Arkansas
United States	N01199 1380	Louisville	Kentucky
United States	N01199 1369	Milwaukee	Wisconsin
United States	N01199 1061	Nashville	Tennessee
United States	N01199 1053	New York	New York
United States	N01199 1392	Newport Beach	California
United States	N01199 1052	Paducah	Kentucky
United States	N01199 1055	Philadelphia	Pennsylvania
United States	N01199 1059	Philadelphia	Pennsylvania
United States	N01199 1051	Phoenix	Arizona
United States	N01199 1362	Phoenix	Arizona
United States	N01199 1359	Portland	Oregon
United States	N01199 1393	Richmond	Virginia
United States	N01199 1365	Rochester	New York
United States	N01199 1083	Ruston	Louisiana
United States	N01199 1352	Saint Louis	Missouri
United States	N01199 1389	Saint Paul	Minnesota
United States	N01199 1082	Salt Lake City	Utah
United States	N01199 1087	San Francisco	California
United States	N01199 1368	San Francisco	California
United States	N01199 1376	Seattle	Washington
United States	N01199 1388	Springfield	Illinois
United States	N01199 1062	Toms River	New Jersey
United States	N01199 1374	Tucson	Arizona
United States	N01199 1079	Tupelo	Mississippi
United States	N01199 1375	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
UCB PHARMA Inc. (US)

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  India,  Mexico, 

References & Publications (2)

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

O'Brien TJ, Borghs S, He QJ, Schulz AL, Yates S, Biton V. Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial. Epi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period	Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Primary	Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period	Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Primary	Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period	A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Secondary	Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period	Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].; A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.	From Baseline of the previous study to the Evaluation Period (up to 11 years)
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.	From Baseline of the previous study to the Evaluation Period (up to 11 years)
Secondary	Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period	A responder is defined as a subject with a higher than or equal to (>=) 50 % change in seizure frequency from Baseline period of the previous study.	From Baseline of the previous study to the Evaluation Period (up to 11 years)