NCT05492695

Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Diamond Headache Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Galcanezumab	Galcanezumab is a calcitonin-gene related peptide antagonist indicated in adults for the preventive treatment of migraine and the treatment of episodic cluster headache.
OTHER	Placebo	Galcanezumab' placebo. This is the same vehicle as the study intervention formulation but does not contain active galcanezumab-gnlm.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-09-28
• Completion: 2023-09-28
• First posted: 2022-08-08
• Last updated: 2023-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study