{
  "abstract": "Introduction There are limited well-tolerated preventive migraine treatments approved for children and adolescents. The multicentre, parallel-group, Phase 3 SPACE study ( NCT04458857) evaluated the efficacy and safety of fremanezumab, a calcitonin gene-related peptide monoclonal antibody, in children and adolescents with episodic migraine (EM).Methods Eligible participants (aged 6–17 years, migraine diagnosis ≥6 months and history of ≤14 headache days/month) were randomised 1:1 to monthly fremanezumab (120 mg for <45kg, 225 mg for ≥45kg) or placebo. Primary endpoint: least-squares (LS) mean change from baseline in monthly average number of migraine days (MMD) during the 3-month double-blind period. Safety was assessed through adverse events (AE), laboratory tests and electrocardiogram findings.Results In total, 235 randomised participants were included in the safety analysis set (fremanezumab, n=123 [120 mg, n=36; 225 mg, n=87]; placebo, n=112). The proportion of participants reporting any AE was consistent across treatment groups. Injection site reactions were the most common AEs reported more frequently with fremanezumab versus placebo. The proportion of participants with serious AEs and AEs leading to discontinuation were low. No deaths were reported.Conclusions These findings suggest fremanezumab provides a well-tolerated preventive migraine treatment option in children and adolescents with EM, with no new safety signals observed.mark.fredericks@tevauk.com",
  "authors": [
    {
      "affiliations": [
        "Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, OH, USA"
      ],
      "name": "Hershey Andrew D"
    },
    {
      "affiliations": [
        "Children’s Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, USA"
      ],
      "name": "Szperka Christina L"
    },
    {
      "affiliations": [
        "Teva UK Limited, Castleford, UK"
      ],
      "name": "Fredericks Mark"
    },
    {
      "affiliations": [
        "Teva Branded Pharmaceutical Products RandD, Inc., West Chester, PA, USA"
      ],
      "name": "Barash Steve"
    },
    {
      "affiliations": [
        "Teva Branded Pharmaceutical Products RandD, Inc., West Chester, PA, USA"
      ],
      "name": "Garnett Sally"
    },
    {
      "affiliations": [
        "Teva Branded Pharmaceutical Products RandD, Inc., West Chester, PA, USA"
      ],
      "name": "Bryson Juline"
    },
    {
      "affiliations": [
        "Teva Pharmaceutical Industries Ltd, Tel Aviv, Israel"
      ],
      "name": "Kessler Yoel"
    },
    {
      "affiliations": [
        "Teva Pharmaceutical Industries Ltd, Tel Aviv, Israel"
      ],
      "name": "Erez Tamar"
    },
    {
      "affiliations": [
        "Teva Pharmaceutical Industries Ltd, Tel Aviv, Israel"
      ],
      "name": "Carmeli Schwartz Yael"
    }
  ],
  "title": "114 Fremanezumab for episodic migraine prevention in children and adolescents: safety outcomes from a randomised trial",
  "uid": "c7dcfc65-6752-500e-92da-a9f99ccd5b7a"
}