Phase 3
Completed N=106
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
Source: ClinicalTrials.gov NCT02582866 ↗Enrolled (actual)
106
Serious AEs
14.1%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator — 59.4 percentage of participants
◆ Published Evidence
Established
24citations · ~5 / year
Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial.
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.
Linked Publications (2)
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Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial.
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Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator |
59.4 | — |
| PRIMARY Percentage of Participants That Withdrew Due to Adverse Events (AEs) |
0.9 | — |
| PRIMARY Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator |
14.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02582866) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.