Abstract Details

Title Efficacy and Safety of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Children and Adolescents: Outcomes from Two Randomized, Double-blind, Placebo-controlled, Phase 3 Studies

Topic Headache

Presentation(s) S37 - Headache Clinical Trials (11:39 AM-11:51 AM)

Poster/Presentation
Number 003

Objective

To evaluate the efficacy and safety of fremanezumab in children and adolescents with episodic (EM; NCT04458857) or chronic migraine (CM; NCT04464707).

Background

Migraine is common in children and adolescents, causing school absences, impaired educational performance, and missed social activities. Fremanezumab, a calcitonin gene-related peptide pathway monoclonal antibody, has demonstrated efficacy and safety in multiple randomized controlled trials in adults with EM and CM. However, efficacy and safety data for fremanezumab in children and adolescents are limited.

Design/Methods

In two multicenter, Phase 3 trials, eligible participants (aged 6–17 years; migraine diagnosis for ≥6 months; history of ≤14 [EM] or ≥15 headache days/month [CM]), were randomized 1:1 to monthly fremanezumab (<45kg, 120 mg; ≥45kg, 225 mg) or placebo for 3 months. Primary endpoint: least squares mean change from baseline in average monthly migraine days (MMD) during the 3-month double-blind period. Secondary endpoints included mean change from baseline in monthly headache days of at least moderate severity (MHD), ≥50% MMD response rates, and safety.

Results In total, 234 and 289 participants from the EM and CM studies, respectively, were included in the efficacy analyses. Fremanezumab significantly reduced MMD versus placebo (–2.5 vs –1.4; p=0.0210) in the EM study; no significant difference was observed between treatment groups in the CM study (–3.8 vs –3.7; p=0.8484). In the EM study, MHD reduction was significantly greater with fremanezumab versus placebo (–2.6 vs –1.5; p=0.0172), as was the ≥50% MMD response rate (47.2% vs 27.0%; p=0.0016). Adverse event frequency was similar for fremanezumab and placebo; serious AEs and AEs leading to discontinuation were infrequent.

Conclusions

Treatment with fremanezumab led to statistically significant reductions in MMD and MHD in children and adolescents with EM, but not in children and adolescents with CM. Safety findings were consistent with those observed in pivotal adult trials.

Authors/Disclosures
Juline Bryson, MD (Teva Pharmaceuticals) PRESENTER	Dr. Bryson has received personal compensation for serving as an employee of Teva Pharmaceuticals. Dr. Bryson has or had stock in Teva .
Andrew D. Hershey, MD, PhD, FAAN, FAHS, FAAN	The institution of Dr. Hershey has received personal compensation in the range of $0-$499 for serving as a Consultant for Amgen. The institution of Dr. Hershey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. The institution of Dr. Hershey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. The institution of Dr. Hershey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Upsher-Smith. The institution of Dr. Hershey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. The institution of Dr. Hershey has received research support from Amgen. The institution of Dr. Hershey has received research support from NIH, NINDS. The institution of Dr. Hershey has received research support from Bioahaven. The institution of Dr. Hershey has received research support from Upsher-Smith. Dr. Hershey has received publishing royalties from a publication relating to health care.
Christina L. Szperka, MD, FAAN (Children's Hospital of Philadelphia)	The institution of Dr. Szperka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. The institution of Dr. Szperka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. The institution of Dr. Szperka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Szperka has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Szperka has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Upsher Smith. The institution of Dr. Szperka has received research support from PCORI. Dr. Szperka has a non-compensated relationship as a Cochair Scientific Committee with American Headache Society that is relevant to AAN interests or activities.
Piero Barbanti, MD	Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli-Lilly. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Fondazione Ricerca e Salute. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Barbanti has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Visufarma. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Assosalute. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli-Lilly. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Organon. Dr. Barbanti has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Barbanti has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TEVA. Dr. Barbanti has received publishing royalties from a publication relating to health care.
Patricia Pozo-Rosich, MD, PhD	Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pozo-Rosich has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Organon. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr. Reddy's. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sociedad Española Neurologia.
lian li, lianli	Hon. li has nothing to disclose.
Suzy-Erin Collins	Miss Collins has received personal compensation for serving as an employee of Veramed Limited.
Yoel Kessler, MD	Dr. Kessler has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Yael Carmeli Schwartz, CPM	Mrs. Carmeli Schwartz has received personal compensation for serving as an employee of Teva Pharmaceutical Ltd..
Verena Ramirez Campos, MD (Teva)	Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
Xiaoping Ning (Teva pharmaceuticals)	Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical . Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical.

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