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Trial record 90 of 146 for:    epilepsy AND Bethesda

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

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ClinicalTrials.gov Identifier: NCT00150800
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB PHARMA Inc. (US) )

Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 668 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Brivaracetam
Brivaracetam used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.
Drug: Brivaracetam
  • Active Substance: Brivaracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 10 mg and 25 mg
  • Route of Administration: Oral




Primary Outcome Measures :
  1. Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period [ Time Frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) ]
    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.

  2. Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period [ Time Frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) ]
    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.

  3. Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period [ Time Frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) ]
    A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.


Secondary Outcome Measures :
  1. Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period [ Time Frame: From Baseline of the previous study to the Evaluation Period (up to 11 years) ]

    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.


  2. Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period [ Time Frame: From Baseline of the previous study to the Evaluation Period (up to 11 years) ]

    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.


  3. Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period [ Time Frame: From Baseline of the previous study to the Evaluation Period (up to 11 years) ]
    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.



Information from the National Library of Medicine

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

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

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): NCT00150800


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Sponsors and Collaborators
UCB PHARMA Inc. (US)
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)
  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB PHARMA Inc. (US) ):
Study Protocol  [PDF] October 15, 2015
Statistical Analysis Plan  [PDF] April 20, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UCB PHARMA Inc. (US)
ClinicalTrials.gov Identifier: NCT00150800     History of Changes
Other Study ID Numbers: N01199
First Posted: September 8, 2005    Key Record Dates
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018
Last Verified: November 2018
Keywords provided by UCB Pharma ( UCB PHARMA Inc. (US) ):
Brivaracetam
Epilepsy
Partial Onset Seizures
open label
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brivaracetam
Anticonvulsants