A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine

Conditions

• Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• MEDI0618 — DRUG
  MEDI0618 per protocol
• Placebo — DRUG
  Volume-matched placebo for all arms

Study Details

The purpose of this Phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine.

Key Dates

Start date

Oct 7, 2024

Status verified

May 2026

Primary completion

Dec 18, 2026

Completion

May 7, 2027

Study Design

Enrollment

488 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: aCGRP-N_MEDI0618 (Dose A)
  In the aCGRP-N cohort, 160 participants will be randomised on a 1:1 basis to receive MEDI0618 Dose A or placebo. After 104 participants total have been randomised, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each.
• Placebo Comparator: aCGRP-N_Placebo
  In the aCGRP-N cohort, 160 participants will be randomised on a 1:1 basis to receive MEDI0618 Dose A or placebo. After 104 participants total have been randomised, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each.
• Experimental: aCGRP-N_MEDI0618 (Dose B)
  After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.
• Experimental: aCGRP-N_MEDI0618 (Dose C)
  After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.
• Experimental: aCGRP-N_MEDI0618 (Dose D)
  After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.
• Experimental: aCGRP-IR_MEDI0618 (Dose A)
  In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo).
• Placebo Comparator: aCGRP-IR_Placebo
  In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo).

Primary Outcome Measure

Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine [ Time Frame: Week 9 to Week 12 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (16)

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