Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Lacosamide

• Registration Number: NCT00530855
• Lead Sponsor: UCB Pharma

Brief Summary

This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-14
• Study First Submitted QC: 2007-09-14
• Study First Posted: 2007-09-18
• Study Start: 2008-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-05-18
• Results First Submitted QC: 2015-05-18
• Results First Posted: 2015-06-03
• Status Verified: 2017-07
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

• Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)

Exclusion Criteria

• Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	Lacosamide tablets for dosing 100 -800 mg/day

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study	From Visit 1 to End of Study (approximately 2 years)	Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study	From Visit 1 to End of Study (approximately 2 years)	Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.

Secondary Outcome Measures

Name	Time	Method
Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study	From Visit 1 to End of Study (approximately 2 years)	A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.; An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study	From Visit 1 to End of Study (approximately 2 years)

Trial Locations

Locations (108)

048; 🇺🇸 Alabaster, Alabama, United States

010; 🇺🇸 Birmingham, Alabama, United States

042; 🇺🇸 Northport, Alabama, United States

009; 🇺🇸 Phoenix, Arizona, United States

014; 🇺🇸 Phoenix, Arizona, United States

151; 🇺🇸 Phoenix, Arizona, United States

103; 🇺🇸 Tucson, Arizona, United States

102; 🇺🇸 Jonesboro, Arkansas, United States

007; 🇺🇸 Little Rock, Arkansas, United States

086; 🇺🇸 Little Rock, Arkansas, United States

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