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A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083665
Recruitment Status : Completed
First Posted : March 20, 2017
Last Update Posted : October 10, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 20, 2017
Last Update Posted Date October 10, 2022
Actual Study Start Date  ICMJE August 22, 2017
Actual Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2022)
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From start of the Treatment Period (Week 2) until Safety Visit (up to Week 18) ]
    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.
  • Incidence of Treatment-Emergent AEs (TEAEs) leading to study withdrawal [ Time Frame: From start of the Treatment Period (Week 2) until Safety Visit (up to Week 18) ]
    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.
  • Incidence of Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: From start of the Treatment Period (Week 2) until Safety Visit (up to Week 18) ]
    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.
  • Partial seizure frequency per 28 days during the 12-week Treatment Period [ Time Frame: From Baseline to 12-weeks Treatement Period ]
    Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
Percent change in partial seizure frequency during the 12-week Treatment Period [ Time Frame: From baseline to 12-weeks Tratement period ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2022)
  • 50% responder rate based on percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
    Responders are those subjects with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days
  • Percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
    Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period.
  • Categorized percent change in partial seizures frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
    Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100.
  • All seizure frequency (partial, generalized, and unclassified epileptic seizures) per 28 days during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
    There are three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III).
  • Seizure freedom (partial, all epileptic seizure) during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
    A subject was considered seizure free, if no seizure was reported during the 12-week Treatment Period.
  • Time to 1st partial seizure during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
    Number of days to first seizure after Baseline.
  • Time to 5th partial seizure during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
    Number of days to fifth seizure after Baseline.
  • Time to 10th partial seizure during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
    Number of days to tenth seizure after Baseline.
  • Brivaracetam plasma levels [ Time Frame: Plasma samples will be collected in week 2, 4, 8, 12, 14. ]
    Blood samples will be collected at indicated time points to determine the brivaracetam plasma concentration.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • 50% responder rate based on percent reduction in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
    Responders are those subjects with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days
  • Percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
  • Categorized percent change in partial seizures frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
  • All seizure frequency (partial, generalized, and unclassified epileptic seizures) per 28 days during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
  • Percentage of subjects who are seizure free (partial, all epileptic seizures) during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
  • Time to nth (n= 1, 5, 10) partial seizure during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
  • Brivaracetam plasma concentration [ Time Frame: Plasma samples will be collected in week 2, 4, 8, 12, 14. ]
  • Adverse events (AEs) [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
  • Change from Baseline in laboratory tests [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
  • Change from Baseline in electrocardiogram (ECG) [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
  • Change from Baseline in vital signs [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
  • Change from Baseline in body weight [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
  • Change from Baseline in physical examination [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
  • Change from Baseline in neurological examination [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
  • Change from Baseline in mental status, and psychiatric staus [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
  • Change from Baseline in psychiatric staus [ Time Frame: From Screening (Week -8) until Safety Visit (Week 18) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization
Brief Summary The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects >= 16 years to 80 years of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Partial Seizures With or Without Secondary Generalization
  • Epilepsy
Intervention  ICMJE
  • Drug: Placebo
    • Pharmaceutical form: Film-coated tablets
    • Route of administration: Oral use
  • Drug: Brivaracetam
    • Pharmaceutical form: Film-coated tablets
    • Concentration: 25 mg tablets and 50 mg tablets
    • Route of administration: Oral use
    Other Name: Briviact
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    • 12 weeks Treatment Period: Subjects will receive Placebo
    • 4 weeks Down-Titration Period: Subjects will receive Placebo
    Intervention: Drug: Placebo
  • Experimental: BRV 50 mg/day

    12 weeks Treatment Period: Subjects will receive BRV 50 mg/day

    - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 50 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day

    - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 25 mg/day for 1 week followed by Placebo for 3 weeks, followed by a Study Drug-Free Period

    Interventions:
    • Drug: Placebo
    • Drug: Brivaracetam
  • Experimental: BRV 200 mg/day

    12 weeks Treatment Period: Subjects will receive BRV 200 mg/day

    - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 150 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day

    - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week followed by a Study Drug-Free Period

    Interventions:
    • Drug: Placebo
    • Drug: Brivaracetam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2022)
449
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
504
Actual Study Completion Date  ICMJE June 30, 2022
Actual Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive
  • Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
  • Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
  • Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
  • Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED

Exclusion Criteria:

  • Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
  • Subject is currently treated with levetiracetam
  • Subject has taken levetiracetam within 90 days prior to Visit 1
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Japan,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03083665
Other Study ID Numbers  ICMJE EP0083
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
URL: https://vivli.org/
Current Responsible Party UCB Pharma ( UCB Biopharma SRL )
Original Responsible Party UCB Biopharma S.P.R.L.
Current Study Sponsor  ICMJE UCB Biopharma SRL
Original Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares 001 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP