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Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures

Primary Purpose

Epilepsies, Partial

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Lacosamide
Sponsored by
UCB Biopharma S.P.R.L.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Epilepsies, Partial

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patient has completed the Termination Visit of SP0994 and has been treated with Lacosamide (LCM) monotherapy
  • Patient is expected to benefit from participation in the Compassionate Use Program (CUP) with LCM monotherapy, in the opinion of the treating physician
  • Patient is willing and able to comply with all program requirements
  • Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if applicable to local regulations, has given written informed consent

Exclusion Criteria:

  • Patient is receiving any investigational drugs or using any experimental devices in addition to LCM
  • For countries where LCM is reimbursed: Patient requires another anti-epileptic drug (AED) for the treatment of seizures For countries where LCM is not reimbursed (or conditionally reimbursed: Belgium, Australia e.g.): Patient requires another AED for the treatment of seizures and qualifies for commercial LCM (and LCM is being reimbursed)
  • Patient experienced emergence of a seizure type other than partial-onset or generalized tonic-clonic seizures, or occurrence of status epilepticus
  • Patient developed second- or third-degree atrioventricular (AV) block or another clinically relevant change in medical condition (or electrocardiogram (ECG) or laboratory parameter)
  • Patient having liver function test (LFT) results of transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ≥3×ULN to <5×upper limit of normal (ULN)
  • Patient has actual suicidal ideation or behavior
  • Patient is experiencing an ongoing serious adverse event (SAE) and there is no expected benefit for him/her to continue on LCM treatment
  • Female patient who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception (according to ICH guidance defined as those that result in a failure rate of less than 1 % per year when used consistently and correctly), unless sexually abstinent, for the duration of the study
  • Patient was treated with carbamazepine controlled release (CBZ-CR) in SP0994

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 5, 2018
    Last Updated
    October 29, 2019
    Sponsor
    UCB Biopharma S.P.R.L.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03559673
    Brief Title
    Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures
    Official Title
    Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0994 Study
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UCB Biopharma S.P.R.L.

    4. Oversight

    5. Study Description

    Brief Summary
    The objective of this Compassionate Use Program (CUP) is to provide continued access to Lacosamide (LCM) for monotherapy use for patients who were receiving LCM in SP0993 and SP0994 at the time of study unblinding and close of SP0994, and who benefited from the treatment per investigator assessment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsies, Partial

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Lacosamide
    Other Intervention Name(s)
    Vimpat
    Intervention Description
    Patients will start on the individual Lacosamide (LCM) dose that they had reached at the completion of the previous monotherapy study. LCM will be administered orally twice daily in 2 divided doses.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Eligibility Criteria
    Inclusion Criteria: Patient has completed the Termination Visit of SP0994 and has been treated with Lacosamide (LCM) monotherapy Patient is expected to benefit from participation in the Compassionate Use Program (CUP) with LCM monotherapy, in the opinion of the treating physician Patient is willing and able to comply with all program requirements Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if applicable to local regulations, has given written informed consent Exclusion Criteria: Patient is receiving any investigational drugs or using any experimental devices in addition to LCM For countries where LCM is reimbursed: Patient requires another anti-epileptic drug (AED) for the treatment of seizures For countries where LCM is not reimbursed (or conditionally reimbursed: Belgium, Australia e.g.): Patient requires another AED for the treatment of seizures and qualifies for commercial LCM (and LCM is being reimbursed) Patient experienced emergence of a seizure type other than partial-onset or generalized tonic-clonic seizures, or occurrence of status epilepticus Patient developed second- or third-degree atrioventricular (AV) block or another clinically relevant change in medical condition (or electrocardiogram (ECG) or laboratory parameter) Patient having liver function test (LFT) results of transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ≥3×ULN to <5×upper limit of normal (ULN) Patient has actual suicidal ideation or behavior Patient is experiencing an ongoing serious adverse event (SAE) and there is no expected benefit for him/her to continue on LCM treatment Female patient who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception (according to ICH guidance defined as those that result in a failure rate of less than 1 % per year when used consistently and correctly), unless sexually abstinent, for the duration of the study Patient was treated with carbamazepine controlled release (CBZ-CR) in SP0994
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Cares
    Organizational Affiliation
    001 844 599 2273 (UCB)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures

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