Forskning
Udskriv Udskriv
Switch language
Rigshospitalet - en del af Københavns Universitetshospital
Udgivet

Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1)

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Prevalence of pre-cluster symptoms in episodic cluster headache: Is it possible to predict an upcoming bout?

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Hypersensitivity to calcitonin gene-related peptide in chronic migraine

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Neurovascular contact plays no role in trigeminal neuralgia secondary to multiple sclerosis

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Real-life treatment of cluster headache in a tertiary headache center - results from the Danish Cluster Headache Survey

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. No additive effect of combining sumatriptan and olcegepant in the GTN mouse model of migraine

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Amylin Analog Pramlintide Induces Migraine-like Attacks in Patients

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Cerebrovascular effects of glibenclamide investigated using high-resolution magnetic resonance imaging in healthy volunteers

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Effect of Adrenomedullin on Migraine-like Attacks in Patients With Migraine: A Randomized Crossover Study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Hypersensitivity to calcitonin gene-related peptide in chronic migraine

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. Reference programme: diagnosis and treatment of headache disorders and facial pain. Danish Headache Society, 3rd edition, 2020

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • Messoud Ashina
  • Joel Saper
  • Roger Cady
  • Barbara A Schaeffler
  • David M Biondi
  • Joe Hirman
  • Susan Pederson
  • Brent Allan
  • Jeff Smith
Vis graf over relationer

OBJECTIVE: To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of episodic migraine.

METHODS: The PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-1 (PROMISE-1) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with episodic migraine were randomized to eptinezumab 30 mg, 100 mg, 300 mg, or placebo for up to four intravenous (IV) doses administered every 12 weeks. The primary endpoint was change from baseline in monthly migraine days (MMDs) over weeks 1-12.

RESULTS: A total of 888 patients received treatment across 84 study sites. Mean MMDs at baseline was ∼8.6 across treatment groups. Eptinezumab 100 mg and 300 mg met the primary endpoint, significantly reducing MMDs across weeks 1-12 compared with placebo (30 mg, -4.0; 100 mg, -3.9, p = 0.0182; 300 mg, -4.3; placebo, -3.2, p = 0.0001). Treatment-emergent adverse events were reported by 58.4% (30 mg), 63.2% (100 mg), 57.6% (300 mg), and 59.5% (placebo) of patients. Treatment-emergent adverse events reported by ≥2% of eptinezumab-treated patients at an incidence greater than placebo included: upper respiratory tract infection (30 mg, 11.4%; 100 mg, 9.9%; 300 mg, 10.3%; placebo, 7.2%), and fatigue (30 mg, 2.3%; 100 mg, 3.6%; 300 mg, 3.6%; placebo, <1%).

CONCLUSION: Eptinezumab (100 mg or 300 mg) significantly reduced migraine frequency, was well tolerated, and had an acceptable safety profile when used for the preventive treatment of migraine in adults with episodic migraine. ClinicalTrials.gov identifier: NCT02559895.

OriginalsprogEngelsk
TidsskriftCephalalgia : an international journal of headache
Vol/bind40
Udgave nummer3
Sider (fra-til)241-254
ISSN0333-1024
DOI
StatusUdgivet - mar. 2020

ID: 59482695