Kronik Migrenin Önlenmesinde Galcanezumab'ın Değerlendirilmesi

Sade dilde özet

Bu çalışma, kronik migreni (chronic migraine) olan hastalarda migren ataklarının önlenmesinde Galcanezumab ilacını plaseboyla karşılaştırarak değerlendirmektedir. Çalışmaya, en az bir yıldır migren öyküsü olan ve 50 yaşından önce migreni başlamış kronik migren hastaları katılabilmektedir. Çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Eli Lilly and Company

Müdahale

Galcanezumab, Placebo

Başlangıç

30.11.2015

Tahmini bitiş

14.07.2021

Ülkeler

United States, Argentina, Canada, Czechia, Germany, Israel, Italy, Mexico, Netherlands, Puerto Rico, Spain, Taiwan, United Kingdom

İlgili genler

Merkezler

• Phoenix, United States
• Phoenix, United States
• Encino, United States
• Fullerton, United States
• Los Alamitos, United States
• Newport Beach, United States
• Rancho Mirage, United States
• Redlands, United States
• San Diego, United States
• San Diego, United States
• San Francisco, United States
• Englewood, United States
• Fort Collins, United States
• Fairfield, United States
• DeLand, United States
• Jacksonville, United States
• Ocala, United States
• Orlando, United States
• Oviedo, United States
• West Palm Beach, United States
• Boise, United States
• Champaign, United States
• Riverwoods, United States
• Indianapolis, United States
• Prairie Village, United States
• Wichita, United States
• Baltimore, United States
• Boston, United States
• Ann Arbor, United States
• Minneapolis, United States
• Hazelwood, United States
• Springfield, United States
• Albuquerque, United States
• Amherst, United States
• Plainview, United States
• Cincinnati, United States
• Tulsa, United States
• Pleasant Hills, United States
• Willow Grove, United States
• Charleston, United States

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Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

Main Study:

* Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

Israel addendum:

* Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.
* Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.

Exclusion Criteria:

* Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
* Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
* History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.