NCT00136019

Brief Summary

Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in a research study at approximately 85 different locations in the United States. The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide \[SPM 927\]) taken orally twice a day for about five months. Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide up to the target dose of 400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks. The study clinic visits will include a medical history and physical exam, electrocardiogram (ECG), blood and urine sample collection, and completion of a seizure diary. Patients who complete the study may enroll in an extension trial and receive active study drug.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

September 22, 2014

Status Verified

July 1, 2010

Enrollment Period

2.4 years

First QC Date

August 24, 2005

Last Update Submit

September 19, 2014

Conditions

Epilepsy

Keywords

Epilepsy with partial seizures

Outcome Measures

Primary Outcomes (1)

  • Efficacy is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status.

Secondary Outcomes (1)

  • Safety of lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data.

Interventions

SPM 927DRUG

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Epilepsy with partial seizures

You may not qualify if:

  • Subject received SPM 927 in a previous trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P; SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010 Jun;51(6):958-67. doi: 10.1111/j.1528-1167.2009.02496.x. Epub 2010 Jan 27.

    PMID: 20132285RESULT

  • Sake JK, Hebert D, Isojarvi J, Doty P, De Backer M, Davies K, Eggert-Formella A, Zackheim J. A pooled analysis of lacosamide clinical trial data grouped by mechanism of action of concomitant antiepileptic drugs. CNS Drugs. 2010 Dec;24(12):1055-68. doi: 10.2165/11587550-000000000-00000.

    PMID: 21090839RESULT

  • Borghs S, de la Loge C, Cramer JA. Defining minimally important change in QOLIE-31 scores: estimates from three placebo-controlled lacosamide trials in patients with partial-onset seizures. Epilepsy Behav. 2012 Mar;23(3):230-4. doi: 10.1016/j.yebeh.2011.12.023. Epub 2012 Feb 15.

    PMID: 22341962RESULT

  • Biton V, Gil-Nagel A, Isojarvi J, Doty P, Hebert D, Fountain NB. Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: Analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials. Epilepsy Behav. 2015 Nov;52(Pt A):119-27. doi: 10.1016/j.yebeh.2015.09.006. Epub 2015 Sep 27.

    PMID: 26414341DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

March 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

September 22, 2014

Record last verified: 2010-07