New Methods for Evaluating Preventive Migraine Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Active drug for chronic migraine treatment.: Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously

Placebo Subcutaneous injection: Inactive placebo (saline) injected subcutaneously in the same volume as the active drug

Study summary

The study aims to test interactions between drug and placebo-responses in acute migraine treatment and to assess variation in adverse events according to treatment information provided. Using a clinical within-subjects, balanced placebo design, patients with chronic migraine will receive four treatment conditions in a randomized order.

Eligibility

Primary outcome measure(s)

• Mean change in headache intensity — Measured every day during the 8 month trial period
  Headache intensity rated on a 11-point Numerical Rating Scale (0=no pain; 10=worst pain intensity) measured 28 days before and after each treatment administration.
• Mean change in moderate/severe headache days — Measured every day during the 8 month trial period
  Total number of moderate/severe headache days will be measured 28 days before and after each treatment administration. Moderate/severe headache days will be recorded by the presence of headache (yes/no), peak pain intensity (mild/moderate/severe), and duration (\< 4h or ≥ 4h), as well as acute medication intake and treatment response.
• Adverse events — 24 hours, 14 and 28 days after each treatment administration
  Occurrence of adverse events in each treatment condition recorded by the presence of adverse events ascribed to the treatment, measured using free recall and prompting. For each prompted symptom, participants respond "yes" or "no" and indicate whether they believe the symptom is related to the medication, the migraine attack, or another cause.

Trial sites (2)

More University of Aarhus trials in Denmark

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