Cabergoline for Episodic Migraine

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

March 1, 2028

Study Completion Date

September 1, 2028

Conditions
Migraine
Interventions
DRUG

Cabergoline 0.5 MG

Participants will receive cabergoline 0.5 mg as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. Participants who received cabergoline 0.5 mg during the double-blind phase will continue with the same 0.5 mg dose in the open-label phase.

DRUG

Placebo

Participants will receive placebo as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. In the open-label phase, these participants will transition to active cabergoline treatment, receiving either 0.5 mg or 1.0 mg once weekly, depending on their randomized allocation at the start of the open-label phase. The placebo tablets will be formulated to match the cabergoline tablets in size, shape, and color, and should be taken under the same conditions.

DRUG

Cabergoline 1 MG

Participants will receive cabergoline 1.0 mg as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. Participants who received cabergoline 1.0 mg during the double-blind phase will continue with the same 1.0 mg dose in the open-label phase.

All Listed Sponsors
lead

University of Aarhus

OTHER