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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

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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 )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Partial Seizures With or Without Secondary Generalization Epilepsy Drug: Placebo Drug: Brivaracetam Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 22, 2017
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
  • 12 weeks Treatment Period: Subjects will receive Placebo
  • 4 weeks Down-Titration Period: Subjects will receive Placebo
 Drug: Placebo
  • Pharmaceutical form: Film-coated tablets
  • Route of administration: Oral use
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

 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
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

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083665


Locations
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Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
More Information
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT03083665    
Other Study ID Numbers: EP0083
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Epilepsy
Partial seizures with or without secondary generalization
Brivaracetam
Briviact
Additional relevant MeSH terms:
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Neoplasm Metastasis
Epilepsy
Seizures
Neoplastic Processes
Neoplasms
Pathologic Processes
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Brivaracetam
Anticonvulsants