325 Participants Needed

Galcanezumab for Pediatric Migraine

(REBUILD-1 Trial)

Recruiting at 138 trial locations
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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take certain therapeutic antibodies during the study.

What data supports the effectiveness of the drug Galcanezumab for treating migraines?

Research shows that Galcanezumab is effective in reducing the frequency and impact of migraines in adults, as it has been approved for preventing migraines and has shown to improve quality of life and reduce disability in patients with episodic and chronic migraines.12345

Is galcanezumab safe for humans?

Galcanezumab has been studied in adults for migraine prevention and is generally considered safe, with most side effects being mild to moderate. Some serious side effects were reported, such as appendicitis and Crohn's disease, but these were rare. Common side effects included injection-site pain and upper respiratory infections.14678

How is the drug Galcanezumab unique for treating pediatric migraine?

Galcanezumab is unique because it is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP), which plays a key role in migraine development. It is administered as a once-monthly subcutaneous injection, offering a preventive approach for migraines, which is different from many other treatments that are taken more frequently or only during migraine attacks.1491011

Research Team

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for kids and teens aged 6 to 17 with episodic migraines, as defined by IHS ICHD-3 guidelines. They must have had migraines for at least six months before screening. Those who've used certain therapeutic antibodies in the past year or are allergic to monoclonal antibodies can't join.

Exclusion Criteria

I haven't had a major head or neck injury in the last 6 months that worsened my headaches.
I have a history of brain tumors or specific brain malformations.
I have used or been exposed to CGRP antibodies or receptor antibodies.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either galcanezumab or placebo for the prevention of episodic migraine

3 months

Open-label Extension

All participants receive galcanezumab for further evaluation of safety and efficacy

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Galcanezumab
  • Placebo
Trial OverviewThe study tests if Galcanezumab (LY2951742) is better than a placebo at preventing migraine headaches over three months. Participants will be randomly assigned to receive either Galcanezumab or a placebo without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GalcanezumabExperimental Treatment1 Intervention
Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.

Galcanezumab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Emgality for:
  • Prophylaxis of migraine in adults who have at least four migraine days per month
🇺🇸
Approved in United States as Emgality for:
  • Preventive treatment of migraine in adults
  • Treatment of episodic cluster headache

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

In a study involving 1739 adult patients with episodic migraine, those treated with galcanezumab (120 mg or 240 mg) achieved a 100% response rate (no migraine headache days) significantly more often than those receiving a placebo, with rates of 13.5% and 14.3% compared to 5.9% for placebo.
The likelihood of achieving a 100% response increased over the 6-month treatment period, particularly in the last 3 months, with patients experiencing an average of 29 days between migraine headache days for those with at least 1 month of 100% response, and nearly 2 months for those with 3 or more months of 100% response.
100% Response Rate to Galcanezumab in Patients With Episodic Migraine: A Post Hoc Analysis of the Results From Phase 3, Randomized, Double-Blind, Placebo-Controlled EVOLVE-1 and EVOLVE-2 Studies.Rosen, N., Pearlman, E., Ruff, D., et al.[2019]
In a post hoc analysis of patients with episodic (N=879) and chronic (N=555) migraine who did not show significant improvement after 1 month of galcanezumab treatment, a notable percentage still achieved 'good' responses with continued treatment, especially those with 'modest' early improvement (62% for episodic and 38% for chronic).
Even patients with minimal or no early improvement had some chance of achieving a 'good' response with ongoing treatment, although the likelihood was lower, indicating that continued treatment may still be beneficial for certain patients despite initial lack of response.
Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies.Nichols, R., Doty, E., Sacco, S., et al.[2020]
In a 3-month study involving 462 patients with episodic or chronic migraine, galcanezumab significantly reduced interictal burden compared to placebo, as measured by the Migraine Interictal Burden Scale (MIBS-4).
The percentage of patients experiencing severe interictal burden dropped from 59% at baseline to 27% at Month 6 for those treated with galcanezumab, indicating a substantial improvement in quality of life between migraine attacks.
Changes in migraine interictal burden following treatment with galcanezumab: Results from a phase III randomized, placebo-controlled study.Lipton, RB., Buse, DC., Sandoe, CH., et al.[2023]

References

100% Response Rate to Galcanezumab in Patients With Episodic Migraine: A Post Hoc Analysis of the Results From Phase 3, Randomized, Double-Blind, Placebo-Controlled EVOLVE-1 and EVOLVE-2 Studies. [2019]
Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. [2020]
Changes in migraine interictal burden following treatment with galcanezumab: Results from a phase III randomized, placebo-controlled study. [2023]
Galcanezumab: First Global Approval. [2019]
Annual indirect costs savings in patients with episodic or chronic migraine: a post-hoc analysis of phase 3 galcanezumab clinical trials in the United States. [2023]
Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study. [2022]
Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. [2022]
Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. [2021]
Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review. [2021]
Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. [2020]