Prophylactic treatment of hemiplegic migraine with Lamotrigine

Phase 1

• Conditions: Familiar hemplegic migraine; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-003223-30-DE
• Lead Sponsor: niversity Hospital Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-20
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

Diagnosis of hemiplegic migraine according to the International Classification of Headache Disorders 3rd edition (beta version) (ICHD-IIIß)
At least three hemiplegic migraine attacks during the observational phase (i.e. within the 12 months before initiation of lamotrigine ther-apy)
Age > 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Co-existing primary headache disorders
Patients on prophylactic migraine medication within six months before beginning of the trial
Pregnancy, breast feeding and ineffective contraception is present
Cardiac, hepatic or renal disease
Skin disease
Suicidal ideation in the last two years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified