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

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ClinicalTrials.gov Identifier: NCT03559673
Expanded Access Status : Available
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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.

Condition or disease Intervention/treatment
Epilepsies, Partial Drug: Lacosamide

Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
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



Intervention Details:
  • Drug: Lacosamide
    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.
    Other Name: Vimpat

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT03559673


Contacts
Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares 001 844 599 2273 (UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03559673     History of Changes
Other Study ID Numbers: EP0072
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Seizures
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants