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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine

Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 23 Aug 2023

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At a glance

  • Drugs Fremanezumab (Primary)
  • Indications Migraine; Migraine with aura; Migraine without aura
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical

Most Recent Events

  • 12 Aug 2023 Results of planned exploratory analysis from NCT03303079 and NCT03303092 evaluating quality of life , published in the Headache
  • 29 Jul 2021 Results assessing efficacy and safety of two dosing regimens of fremanezumab in Japanese and Korean patients with episodic migraine published in the Headache
  • 24 Jun 2021 According to a Otsuka Pharmaceutical media release, the company received manufacturing and marketing approval from Ministry of Health, Labour and Welfare (MHLW) in Japan for AJOVY [Fremanezumab] Subcutaneous Injection 225 mg Syringe for the indication of preventive treatment of migraine in adult patients.

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