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Trial record 1 of 1 for:    NCT02582866
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A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

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ClinicalTrials.gov Identifier: NCT02582866
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Lacosamide

Lacosamide (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks.

Drug: Lacosamide
  • Pharmaceutical Form: Oral tablets
  • Concentration: 50 mg
  • Route of Administration: Oral administration
Other Names:
  • Vimpat
  • SPM927
  • LCM




Primary Outcome Measures :
  1. Number of Adverse Events (AEs) reported spontaneously by the subject and/or caregiver or observed by Investigator [ Time Frame: From V1 (Week 0) to Final Visit (up to Week 158) ]
  2. Percentage of withdrawals due to Adverse Events (AEs) [ Time Frame: From V1 (Week 0) to Final Visit (up to Week 158) ]
  3. Number of Serious Adverse Events (SAEs) reported spontaneously by the subject and/or caregiver or observed by Investigator [ Time Frame: From V1 (Week 0) to Final Visit (up to Week 158) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An Institutional Review Board /Institutional Ethics Committee approved written Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
  • Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator
  • Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been treated with lacosamide monotherapy

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
  • Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during SP0994
  • Subject required another Anti Epileptic Drug (AED) for the treatment of seizures
  • Subject meets a "must" withdrawal criteria for SP0994
  • Subject is experiencing an ongoing Serious Adverse Event from SP0994
  • Female subject 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, unless sexually abstinent, for the duration of 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): NCT02582866


Locations
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Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Parexel
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02582866    
Other Study ID Numbers: SP1042
2015-001549-96 ( EudraCT Number )
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Lacosamide
Vimpat
Epilepsy
Partial onset seizures
Tonic-clonic seizures
Monotherapy
AED
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action