Fremanezumab for preventive treatment of migraine: Functional status on headache-free days

Neurology. 2018 Sep 18;91(12):e1152-e1165. doi: 10.1212/01.wnl.0000544321.19316.40. Epub 2018 Aug 17.


Objective: To evaluate the effect of fremanezumab on the functional status on headache-free days in phase 2 episodic migraine (EM) and chronic migraine (CM) studies.

Methods: Functional status data were collected prospectively via the electronic headache diary on all headache-free days by patients answering questions regarding work/school/household chore performance, speed of work completion, concentration, and feeling of fatigue. Individuals with EM receiving monthly doses of fremanezumab 225 mg (n = 96) or 675 mg (n = 97) or placebo (n = 104) were compared. Individuals with CM receiving fremanezumab 675 mg followed by monthly 225 mg (n = 88) and 900 mg (n = 86) were also independently compared to those receiving placebo (n = 89).

Results: In patients with EM, compared to patients receiving placebo, those receiving fremanezumab experienced an increased number of headache-free days with normal function in work/school/household chore performance and concentration/mental fatigue measures compared to their baseline over the entire treatment period (all p < 0.005). An increased number of headache-free days with normal functional performance for some measures was also found in the CM group in those treated with fremanezumab.

Conclusion: There was an increased number of headache-free days with normal functional performance on all measures for the patients with EM and some measures for patients with CM in the fremanezumab-treated groups. Further research is required to confirm these findings in a prospective study and to clarify the underlying mechanism(s).

Clinicaltrialsgov identifier: NCT02025556 and NCT02021773.

Classification of evidence: This study provides Class II evidence that for patients with migraine, fremanezumab increases normal functional performance on headache-free days.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Academic Performance*
  • Adolescent
  • Adult
  • Aged
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Clinical Trials, Phase II as Topic / statistics & numerical data*
  • Drug Administration Schedule
  • Fatigue / complications
  • Fatigue / drug therapy
  • Female
  • Humans
  • Male
  • Medical Records
  • Middle Aged
  • Migraine Disorders / complications
  • Migraine Disorders / drug therapy
  • Migraine Disorders / prevention & control*
  • Physical Functional Performance*
  • Prospective Studies
  • Work Performance*
  • Young Adult


  • Antibodies, Monoclonal
  • fremanezumab

Associated data