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
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.
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). 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.