Migreni Olan Japon Katılımcılarda LY2951742 (Galcanezumab) Çalışması

Sade dilde özet

Bu çalışma, migreni (migraine) olan (kronik migren dahil) Japon hastalarda Galcanezumab ilacını değerlendirmektedir. Çalışmaya, en az bir yıllık migren öyküsü olan ve kronik migren tanısı bulunan ya da önceki epizodik migren çalışmasını tamamlamış yetişkinler alınmıştır. 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

Başlangıç

07.02.2017

Tahmini bitiş

10.08.2019

Ülkeler

Japan

İlgili genler

Merkezler

• Chofu-shi, Japan
• Fukui, Japan
• Fukuoka, Japan
• Higashiosaka, Japan
• Hiroshima, Japan
• Ibaraki, Japan
• Iruma-Gun, Japan
• Kagawa, Japan
• Kagoshima, Japan
• Kagoshima, Japan
• Kaisho, Japan
• Kanoya, Japan
• Kasaoka-shi, Japan
• Kasuga-shi, Japan
• Kobe, Japan
• Kochi, Japan
• Kochi, Japan
• Kyoto, Japan
• Kyoto, Japan
• Minatoku, Japan
• Morioka, Japan
• Morioka, Japan
• Narashino-shi, Japan
• Nishinomiya, Japan
• Nishinomiya, Japan
• Okayama, Japan
• Osaka, Japan
• Ota-shi, Japan
• Ōita, Japan
• Ōsaka, Japan
• Ōta-ku, Japan
• Saijo-shi, Japan
• Saitama, Japan
• Sapporo, Japan
• Sapporo, Japan
• Sendai, Japan
• Shibuya-ku, Japan
• Shinjuku-ku, Japan
• Shizuoka, Japan
• Tachikawa-shi, Japan

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Uygunluk kriterleri

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

Inclusion Criteria:

* For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
* 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.

Exclusion Criteria:

* For Chronic Migraine participants:

  * 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 other antibodies of calcitonin gene-related peptide (CGRP) or its receptor.
  * Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
  * 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.
  * Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).