Prophylactic treatment of hemiplegic migraine with Lamotrigine

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003223-30-DE

Enrollment

Registered

2017-02-20

Start date

2017-08-14

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familiar hemplegic migraine

Interventions

Trade Name: Lamotrigin Heumann 25 Product Name: Lamotrigin Pharmaceutical Form: Tablet INN or Proposed INN: LAMOTRIGINE Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Absolute difference in number of hemiplegic migraine attacks be-tween an observational phase (12 months without any prophylactic medication) and an interventional phase (12 months with 200 mg lamotrigine qd [+/- further flexible dose increase up to a maximum of 600mg qd]); Secondary Objective: Proportion of patients without any attacks (attack free patients) during a follow-up of 12 months, starting after the end of dose titration Reduction in the frequency of attacks of migraine with non-hemiplegic aura ;Primary end point(s): Absolute difference in number of hemiplegic migraine attacks between an observational phase (12 months without any prophylactic medication) and an interventional phase (12 months with 200 mg lamotrigine qd [+/- further flexible dose increase up to a maximum of 600mg qd]);Timepoint(s) of evaluation of this end point: Week 114	—

Measure

Time frame

Main Objective: Absolute difference in number of hemiplegic migraine attacks be-tween an observational phase (12 months without any prophylactic medication) and an interventional phase (12 months with 200 mg lamotrigine qd [+/- further flexible dose increase up to a maximum of 600mg qd]); Secondary Objective: Proportion of patients without any attacks (attack free patients) during a follow-up of 12 months, starting after the end of dose titration Reduction in the frequency of attacks of migraine with non-hemiplegic aura ;Primary end point(s): Absolute difference in number of hemiplegic migraine attacks between an observational phase (12 months without any prophylactic medication) and an interventional phase (12 months with 200 mg lamotrigine qd [+/- further flexible dose increase up to a maximum of 600mg qd]);Timepoint(s) of evaluation of this end point: Week 114

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients without any attacks (attack free patients) during a follow-up of 12 months, starting after the end of dose titration Reduction in the frequency of attacks of migraine with non-hemiplegic aura ;Timepoint(s) of evaluation of this end point: Week 114	—

Countries

Germany

Contacts

Public ContactProf Dr. Holger Lerche

University Hospital Tübingen

holger.lerche@med.uni-tuebingen.de+4970712980466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026