Add on Lacosamide Versus High Dose Monotherapy

Epilepsy Clinical Trial

Official title:

Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01345058
• Other study ID #: 2010-P-001630
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 28, 2011
• Last updated: July 20, 2014
• Start date: March 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults age 18 or older

2. Determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk

3. Monotherapy on levetiracetam less than or equal to 1500mg/day for at least two weeks

4. Breakthrough seizure while on stable dose (>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications)

Exclusion Criteria:

1. Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy

2. Pregnant, child-bearing age not using contraception, or breast feeding

3. Medical contraindication to adding lacosamide

4. History of AED polytherapy

5. Presence of a vagus nerve stimulator

6. Creatinine clearance of less than 50mL/min

7. Blood pressure instability: pulse<50 or >100, SBP<50 or >180, clinically significant EKG abnormality

8. History of significant drug rash or anaphylactic reaction with antiepileptic drug

9. Patients with progressive lesions (e.g. brain tumors)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• lacosamide, levetiracetam
Lacosamide will be added to levetiracetam: minimum of 200mg/day, to be titrated as follows: Week 1: 50mg twice a day Week 2: 100mg twice a day.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving six month seizure freedom		6 months	No
Secondary	Number of seizure-free months		6 months	No
Secondary	Time to seizure after therapeutic dose is reached		6 months	No
Secondary	Retention rate		6 months	No
Secondary	Number of reported side effects		6 months	Yes