Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

Completed · Phase 3

Conditions studied: Epilepsy, Monotherapy

In brief

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).

Key facts

Study ID

NCT01465997

Run by

UCB BIOSCIENCES GmbH

People needed

551

Starts

2012-05-01

Expected to finish

2017-01-01

Last updated by the study team

2018-07-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 799 — Huntsville, Alabama, United States
• 777 — Little Rock, Arkansas, United States
• 789 — Panama City, Florida, United States
• 776 — Port Charlotte, Florida, United States
• 873 — Raleigh, North Carolina, United States
• 794 — Oklahoma City, Oklahoma, United States
• 881 — Mansfield, Texas, United States
• 790 — Madison, Wisconsin, United States
• 104 — Chatswood, Australia
• 105 — Clayton, Australia
• 106 — East Gosford, Australia
• 101 — Fitzroy, Australia
• 108 — Heidelberg, Australia
• 103 — Herston, Australia
• 109 — Randwick, Australia
• 127 — Bruges, Belgium
• 134 — Bruges, Belgium
• 128 — Hasselt, Belgium
• 126 — Leuven, Belgium
• 805 — Blagoevgrad, Bulgaria
• 807 — Panagyurishte, Bulgaria
• 803 — Pleven, Bulgaria
• 810 — Rousse, Bulgaria
• 811 — Sofia, Bulgaria
• 786 — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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