- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05052008
Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19
Studieoversigt
Detaljeret beskrivelse
Migraine is a debilitating disorder that affects 37 million people in the United States. Recently, three new injectables calcitonin gene-related peptide (CGRP) receptor antagonists-erenumab, fremanezumab, and galcanezumab-were FDA approved for prophylactic treatment of migraine in adults, that plays a key role in migraine pathophysiology. By blocking the receptor function of CGRP, these agents can reduce the total number of headache days per month and limit the need for using multiple medications. In clinical trials, these agents, which have no drug interactions and minimal adverse reactions, reduced headache days per month by as much as 50% in patients experiencing multiple migraine days each month. These new biologics, however, are more expensive for the patient compared with other prophylactic treatments
The rational of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Fayoum, Egypten, 63111
- Marwa Kamal Ahmed Tolba
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Migraine prevention is an area of a large unmet medical need, with existing prophylactic therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Egyptian adults with chronic migraine (CM).
The study consists of a screening period (up to 24 weeks, including at baseline period), a 12-week period and a 24-week period ,.
Beskrivelse
Inclusion Criteria:
- -Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
- Sexes Eligible for Study: All
History of at least 5 attacks of migraine
-≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
- chronic migraineurs with failure to more than 2 preventive treatments
- chronic migraineurs without any preventive treatments
- Naive to anti CGRP monclonal antibodies
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
• unable to understand the study requirements, the informed consent, or complete headache records as required per protocol;
- History of cluster or hemiplegic headache
- Evidence of seizure or major psychiatric disorder Cardiac or active hepatic disease
- pregnant, actively trying to become pregnant, or breast-feeding;
- episodic migraineurs,
- Other headache types
- allergy to latex;
- received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
- prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway;
- a psychiatric condition, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tværsnit
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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mean number of migraine days
Tidsramme: 6 months
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The primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month.
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6 months
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changes on migraine severity during COVID-19 infection
Tidsramme: during the 6 months
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measuring the severity of migraine attacks on a numerical scale
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during the 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
reduction in migraine days
Tidsramme: during the 6 months
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Secondary end points were a 50% or greater reduction in mean migraine days per month
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during the 6 months
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rate of using migraine medications
Tidsramme: during the 6 months
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change in the number of days of use of acute migraine-specific medication
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during the 6 months
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assessment of migraine effect on physical activity
Tidsramme: during the 6 months
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change in scores on the physical-impairment and everyday-activities domains of the Migraine Physical Function Impact Diary (scale transformed to 0 to 100, with higher score
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during the 6 months
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Schoenen J, Manise M, Nonis R, Gérard P, Timmermans G. Monoclonal antibodies blocking CGRP transmission: An update on their added value in migraine prevention. Rev Neurol (Paris). 2020 Dec;176(10):788-803. doi: 10.1016/j.neurol.2020.04.027. Epub 2020 Aug 2. Review.
- Garland SG, Smith SM, Gums JG. Erenumab: A First-in-Class Monoclonal Antibody for Migraine Prevention. Ann Pharmacother. 2019 Sep;53(9):933-939. doi: 10.1177/1060028019835166. Epub 2019 Feb 27. Review.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Hovedpinelidelser, Primær
- Hovedpine lidelser
- Migræne lidelser
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Calcitonin-gen-relaterede peptidreceptorantagonister
- Erenumab
Andre undersøgelses-id-numre
- Erenumab in migraine
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Erenumab
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AmgenNovartisRekrutteringMigræneForenede Stater, Japan, Belgien, Canada, Det Forenede Kongerige, Tyskland, Polen, Ungarn, Italien, Colombia, Den Russiske Føderation, Finland, Puerto Rico
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AmgenNovartisRekrutteringMigræneForenede Stater, Spanien, Japan, Polen, Belgien, Canada, Det Forenede Kongerige, Tyskland, Ungarn, Italien, Colombia, Den Russiske Føderation, Portugal, Schweiz, Finland, Puerto Rico
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AmgenAfsluttetMigræneForenede Stater, Tyskland, Danmark, Canada, Finland, Sverige, Norge
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AmgenAfsluttetMigræne HovedpineForenede Stater, Østrig, Australien, Tjekkiet, Finland, Frankrig, Ungarn, Italien, Polen, Portugal, Spanien, Det Forenede Kongerige
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University of Maryland, BaltimoreAmgenAfsluttet
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Novartis PharmaceuticalsAfsluttet
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Massachusetts General HospitalUnited States Department of Defense; Recordati Rare DiseasesRekrutteringSmerte, kronisk | Schwannomatose | SchwannomasForenede Stater
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David Jang, M.D.AmgenAfsluttet