Study identifier:D7060C00003
ClinicalTrials.gov identifier:NCT06602479
EudraCT identifier:N/A
CTIS identifier:2024-512904-21-00
A Phase 2, Randomised, Multicentre, Parallel-Group Treatment, Double-Blind Study to Investigate the Safety and Efficacy of Subcutaneous MEDI0618 in the Reduction of Migraine Headache Days Compared to Placebo in Adult Participants with Episodic Migraine
migraine
Phase 2
No
MEDI0618, Placebo
All
408
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: CGRP-N_MEDI0618 (Dose A) In the CGRP-N cohort, there will be 1:1 randomisation to the MEDI0618 and placebo arms until 32 participants have been randomised per arm (32 MEDI0618 Dose A and 32 to placebo) triggering the interim analysis. After 32 participants/arm have been randomised, the randomization will continue with 28 participants on active dose arm. | Drug: MEDI0618 MEDI0618 per protocol |
Placebo Comparator: CGRP-N_Placebo In the CGRP-N cohort, there will be 1:1 randomisation to the MEDI0618 Dose A and placebo arms until 32 participants have been randomised per arm (32 to MEDI0618 Dose A and 32 to placebo) triggering the interim analysis. After 32 participants/arm have been randomised, the randomization will continue with 28 participants with corresponding volume matched placebo for all arms. | Drug: Placebo Volume-matched placebo for all arms |
Experimental: CGRP-N_MEDI0618 (Dose B) After 32 participants/arm have been randomized in the Dose A and placebo arms, the randomization will continue with 56 participants on active dose arm. | Drug: MEDI0618 MEDI0618 per protocol |
Experimental: CGRP-N_MEDI0618 (Dose C) After 32 participants/arm have been randomized in the Dose A and placebo arms, the randomization will continue with 56 participants on active dose arm. | Drug: MEDI0618 MEDI0618 per protocol |
Experimental: CGRP-N_MEDI0618 (Dose D) After 32 participants/arm have been randomized in the Dose A and placebo arms, the randomization will continue with 56 participants on active dose arm. | Drug: MEDI0618 MEDI0618 per protocol |
Experimental: CGRP-IR_MEDI0618 (Dose A) In the CGRP-IR cohort there will be 1:1 randomisation of participants to the two arms (60 to MEDI0618 and 60 to placebo) . | Drug: MEDI0618 MEDI0618 per protocol |
Placebo Comparator: CGRP-IR_Placebo In the CGRP-IR cohort there will be 1:1 randomisation of participants to the two arms (60 to MEDI0618 and 60 to placebo). | Drug: Placebo Volume-matched placebo for all arms |