Phase 3
N=548
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Epilepsy · Monotherapy
Bottom Line
View on ClinicalTrials.gov: NCT01465997 ↗Enrolled (actual)
548
Serious AEs
9.9%
Results posted
Aug 2017
Primary outcome: Primary: Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) — 181; 182 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lacosamide (Drug); Carbamazepine-Controlled Release (CBZ-CR) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- UCB BIOSCIENCES GmbH
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) |
181; 182 | — |
| PRIMARY Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) |
12; 21 | — |
| PRIMARY Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) |
32; 22 | — |
Summary
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).
Eligibility Criteria
Inclusion Criteria
- Subject/legal representative is considered reliable and capable of adhering to the protocol
- Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase
- Subject is expected to benefit from participation in SP0994 in the opinion of the investigator
Exclusion Criteria
- Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR
- Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study
- Subject is taking benzodiazepines for a non-epilepsy indication
- Subject meets a withdrawal criterion from the previous study SP0993
- Subject is experiencing an ongoing SAE from the previous study SP0993
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the "Since Last Visit" version
Data sourced from ClinicalTrials.gov (NCT01465997). 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.