Abstract Details

Title A Randomized, Placebo-Controlled Study of Galcanezumab in Patients with Treatment-Resistant Migraine: Double-Blind Results from the CONQUER Study

Topic Headache

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)

Poster/Presentation
Number 7-008

Objective CONQUER assessed galcanezumab efficacy and safety in patients with migraine who had not benefited from multiple previous migraine preventive treatments.

Background The efficacy and safety of galcanezumab have been previously established in three Phase-3 clinical trials – EVOLVE-1, EVOLVE-2, and REGAIN.

Design/Methods In this phase 3, double-blind study, patients were aged 18-75 years, met criteria for episodic or chronic migraine, had 4-29 migraine headache days per month, and had 2-4 migraine preventive medication category failures in the past 10 years. Eligible patients were randomized 1:1 to receive galcanezumab 120 mg/month (with 240-mg loading dose; N=232) or placebo (N=230). Headache information was captured in a daily electronic diary device. Primary endpoint was overall mean change from baseline in number of monthly migraine headache days across Months 1-3. Key secondary endpoints included ≥50%, ≥75%, or 100% reduction in monthly migraine headache days across Months 1-3 and change from baseline on the Migraine-Specific Quality of Life-Role Function Restrictive domain at Month 3. Efficacy measures were evaluated for both intent-to-treat total population and episodic migraine (EM) subpopulation.

Results Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo. The galcanezumab group averaged 4.1 fewer monthly migraine headache days from a baseline of 13.4, and the placebo group averaged 1.0 fewer from a baseline of 13.0 (between-group difference -3.1; p<0.0001; 95% CI: -3.9, -2.3; effect size=0.72). Galcanezumab was superior to placebo on all key secondary endpoints. There were no statistically significant differences in treatment-emergent adverse events except for those reported more frequently in the placebo group. One galcanezumab-treated patient discontinued early due to an adverse event (rash). Efficacy results for EM subpopulation were consistent with those of the total population.

Conclusions Galcanezumab was superior to placebo in preventive treatment of migraine and was safe and well tolerated in patients who had previous failures to standard-of-care preventive treatments.

Authors/Disclosures
Michel Lanteri-Minet, MD (CHU De Nice) PRESENTER	Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Perfood. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UPSA. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IPSEN. Dr. Lanteri-Minet has received publishing royalties from a publication relating to health care.
W. M. Mulleners, MD	No disclosure on file
Byung-kun Kim, MD (Eulji Hospital, Dept of Neurology)	Dr. Kim has nothing to disclose.
Miguel J. Lainez, MD, PhD, FAAN (Hospital Clinico Univeristario. Universidad Catolica. Valencia)	No disclosure on file
	No disclosure on file
Russell Nichols	Russell Nichols has received personal compensation for serving as an employee of Eli Lilly and Company. Russell Nichols has received stock or an ownership interest from Eli Lilly and Company.
Shufang Wang	No disclosure on file
Antje Tockhorn-Heidenreich	Antje Tockhorn-Heidenreich has received personal compensation for serving as an employee of Eli Lilly and Company. An immediate family member of Antje Tockhorn-Heidenreich has received personal compensation for serving as an employee of Evidera. Antje Tockhorn-Heidenreich has received stock or an ownership interest from Eli Lilly and Company . An immediate family member of Antje Tockhorn-Heidenreich has received stock or an ownership interest from PPD.
Holland Detke	Holland Detke has received personal compensation for serving as an employee of Eli Lilly and Company. Holland Detke has received stock or an ownership interest from Eli Lilly and Company.