Efficacy and safety of lacosamide in patients with erythromelalgia due to SCN9A gene mutation

JRCT ID: jRCTs071180055

Registered date:18/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Familial erythromelalgia
• Date of first enrollment: 21/08/2017
• Target sample size: 6
• Study type: Interventional

Intervention(s)

The administration of lacosamide is maintained on 200 mg/ day, if the symptom do not improve, the dose is increased by 50 mg/day each week until 400 mg/day. In a case of Ccr under 30 ml/min, the dose can be increased up to 300 mg/cay.
If the PI-NSR score is not decrease from the baseline score, the case is judged as valid, lacosamide is administered until the end of this study.

Outcome(s)

Primary Outcome

Amount of change in scoring below 16 weeks after starting lacosamide administration
PI-NRS Pain Intensity Numerical Rating Scale

Secondary Outcome

Amount of change in scoring of PI-NRS and DSIS.
Change over time of blood test ( WBC, Hb, PLT, AST, ALT, BUN, Crea, LDH)

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Older than 15 years
2.A case of erythromelalgia due to SCN9A gene mutation
3.A case who consent to informed consent

Exclude criteria

1.A case with severe liver dysfunction(greater than Child-Pug Score C)2.A case with significant ECG abnormality(second-degree atrioventricular block,Brugada symdrome)
3.A case who is considered by a doctor to be inappropriate for administration of lacosamide.

Related Information

• Primary Sponsor: Takahashi Kenzo
• Secondary ID(s): 000028778