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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2025

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At a glance

  • Drugs Fremanezumab (Primary)
  • Indications Headache; Migraine
  • Focus Registrational; Therapeutic Use
  • Acronyms SPACE
  • Sponsors Teva Branded Pharmaceutical Products R&D

Most Recent Events

  • 06 Aug 2025 According to a Teva Pharmaceuticals media release, company announced today that the U.S. Food and Drug Administration (FDA) has approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more.
  • 07 Apr 2025 According to a Teva Pharmaceutical Industries media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. The application was based on positive results from the Phase 3 SPACE trial.
  • 04 Dec 2024 Primary endpoint has been met (Mean change in the monthly average number of migraine days after the first dose of study drug) , according to Teva Pharmaceutical Industries media release

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