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A pilot, double-blind, randomized, placebo-controlled, dose finding, proof of concept study to evaluate efficacy, safety and tolerability of self- administered subcutaneous diclofenac sodium 25-50-75mg/1ml in the treatment of an acute migraine attack with headache.

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A pilot, double-blind, randomized, placebo-controlled, dose finding, proof of concept study to evaluate efficacy, safety and tolerability of self- administered subcutaneous diclofenac sodium 25-50-75mg/1ml in the treatment of an acute migraine attack with headache.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Apr 2022

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At a glance

  • Drugs Diclofenac (Primary)
  • Indications Headache; Migraine
  • Focus Proof of concept; Therapeutic Use
  • Sponsors IBSA

    • Most Recent Events

    • 26 Apr 2022 Primary endpoint (Percentage of subjects pain free (pain score = zero) at 2 hours after the study drug injection, 50 mg group) has been met, as per results published in the Cephalalgia
    • 26 Apr 2022 Results published in the Cephalalgia
    • 12 Nov 2020 New trial record

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