Epizodik Migren Önlemede Rimegepant'ın Farklı Doz Rejimleriyle Etkinlik ve Güvenlik Çalışması

Sade dilde özet

Bu çalışma, epizodik migren (episodic migraine) ataklarının önlenmesinde Rimegepant ilacının farklı doz rejimlerini (günlük ve gün aşırı) plaseboyla karşılaştırarak etkinliğini ve güvenliğini değerlendirmektedir. Çalışmaya, en az 1 yıldır epizodik migren öyküsü olan ve son 3 ayda ayda 4-14 migren atağı yaşayan kişiler alınmıştır. Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

Pfizer

Müdahale

Rimegepant 75mg daily dosing, Rimegepant 75mg every other day dosing, Placebo comparator dosing

Başlangıç

04.03.2022

Tahmini bitiş

11.12.2024

Ülkeler

United States, Austria, Canada, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom

İlgili genler

Merkezler

• Tempe, United States
• Colton, United States
• Los Angeles, United States
• Newport Beach, United States
• Sherman Oaks, United States
• Boca Raton, United States
• Miami, United States
• Gurnee, United States
• Evansville, United States
• Overland Park, United States
• Springfield, United States
• Las Vegas, United States
• Amherst, United States
• The Bronx, United States
• Williamsville, United States
• Columbus, United States
• Huber Heights, United States
• Medford, United States
• Pittsburgh, United States
• East Greenwich, United States
• Columbia, United States
• Gaffney, United States
• Greenville, United States
• Nashville, United States
• Austin, United States
• Dallas, United States
• Houston, United States
• Magnolia, United States
• Salt Lake City, United States
• Seattle, United States
• Innsbruck, Austria
• Salzburg, Austria
• Calgary, Canada
• Kelowna, Canada
• Vancouver, Canada
• Halifax, Canada
• Brampton, Canada
• Burlington, Canada
• London, Canada
• Sarnia, Canada

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Uygunluk kriterleri

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

Inclusion Criteria:

1\) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4-72 hours if untreated
3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol

Exclusion Criteria:

1. Sex and Reproductive Status:

   1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
   2. Women who are pregnant or breastfeeding
   3. Women with a positive pregnancy test at screening or prior to study drug administration
2. Prohibited Medications:

   1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
   2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
   3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
   4. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
   5. Subjects taking a prohibited medication as defined per protocol