A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache

Lilly

Status and phase: Completed; Phase 2

Conditions: Migraine Headache

Treatments: Drug: Placebo; Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02163993

15414

I5Q-MC-CGAB (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.

Enrollment: 414 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a history of migraine of at least 1 year prior to enrollment.
• Migraine onset prior to age 50.

Exclusion criteria

• Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
• Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
• History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.
• Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.
• Failure to respond to more than two adequately dosed effective migraine prevention treatments.
• Evidence of significant active psychiatric disease, in the opinion of the investigator.
• Women who are pregnant or nursing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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414 participants in 5 patient groups, including a placebo group

5mg Galcanezumab

Experimental group

Description:

5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.

Treatment:

Drug: Galcanezumab

50mg Galcanezumab

Experimental group

Description:

50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.

Treatment:

Drug: Galcanezumab

120mg Galcanezumab

Experimental group

Description:

120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.

Treatment:

Drug: Galcanezumab

300mg Galcanezumab

Experimental group

Description:

300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.

Treatment:

Drug: Galcanezumab

Placebo

Placebo Comparator group

Description:

Placebo given as SQ injections once every 28 days during a 12 week treatment period.

Treatment:

Drug: Placebo