EUCTR2020-001478-30-ROActive, not recruitingPhase 1
A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment
CB Biopharma SR0 sites100 target enrollmentStarted: May 12, 2022Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Participant is male or female, aged <6 years at the time of signing the Informed Consent Form (ICF)
- •- Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848)
- •- Participant is expected to benefit from participation, in the opinion of the Investigator
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study
- •- Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
- •- Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- •- Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for EP0034 or SP848, or is experiencing an ongoing serious adverse event (SAE)
- •- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study
Investigators
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