A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine
A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE
Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack.
The primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
To evaluate the safety and tolerability of rimegepant 75 mg ODT when redosed due to residual pain or headache relapse
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Studieorter
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California
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Canoga Park, California, Förenta staterna, 91303
- Rekrytering
- Hope Clinical Research
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Fresno, California, Förenta staterna, 93710
- Rekrytering
- Neuro-Pain Research Center
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Los Angeles, California, Förenta staterna, 90048
- Rekrytering
- Clinical Research Institute
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Florida
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Boca Raton, Florida, Förenta staterna, 33428
- Rekrytering
- Neurology Offices of South Florida
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Miami, Florida, Förenta staterna, 33176
- Rekrytering
- Brainstorm Research
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Miami, Florida, Förenta staterna, 33126
- Rekrytering
- AppleMedical Research Group, Inc.
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Orlando, Florida, Förenta staterna, 32801
- Rekrytering
- Clinical Neuroscience Solutions
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Illinois
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Chicago, Illinois, Förenta staterna, 60607
- Har inte rekryterat ännu
- Cedar Crosse Research Center
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46256
- Har inte rekryterat ännu
- Josephson Wallack Munshower Neurology
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Massachusetts
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Worcester, Massachusetts, Förenta staterna, 01609
- Rekrytering
- New England Regional Headache Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48104
- Rekrytering
- Michigan Headache & Neurological Institute
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Minnesota
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Burnsville, Minnesota, Förenta staterna, 55337
- Rekrytering
- Minneapolis Clinic of Neurology - Burnsville Office
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Mississippi
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Ridgeland, Mississippi, Förenta staterna, 39157
- Rekrytering
- Proven Endpoints, LLC
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89109
- Har inte rekryterat ännu
- Alliance Clinical Research Las Vegas (Excel Clinical Research)
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Las Vegas, Nevada, Förenta staterna, 89118
- Rekrytering
- M3 Wake Research - Las Vegas Rainbow
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North Carolina
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Greensboro, North Carolina, Förenta staterna, 27405
- Rekrytering
- Headache Wellness Center
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Pennsylvania
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Abington, Pennsylvania, Förenta staterna, 19001
- Har inte rekryterat ännu
- Abington Neurological Associates
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Texas
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Austin, Texas, Förenta staterna, 78731
- Rekrytering
- FutureSearch Trials of Neurology
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Dallas, Texas, Förenta staterna, 75251
- Rekrytering
- FutureSearch Trials of Dallas
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Lake Jackson, Texas, Förenta staterna, 77566
- Rekrytering
- Red Star Research, LLC
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Virginia
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McLean, Virginia, Förenta staterna, 22101
- Rekrytering
- Medstar Health - Department of Neurology
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Tel Aviv, Israel, 6423906
- Rekrytering
- Sourasky Medical Center
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Central District
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Ramat Gan, Central District, Israel, 5265601
- Har inte rekryterat ännu
- Sheba Medical Center
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Jerusalem
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Jerusalem, Jerusalem, Israel, 9103102
- Rekrytering
- Shaare Zedek Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion:
- Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition
- Eligible participants must be currently using acute migraine treatment in accordance with the local label and have all of the following on average across the 12 weeks prior to the Screening Visit and, during the first 28 days of the observation phase (OP): (1) 6-14 monthly migraine days (MMDs); (2) <15 monthly headache days (MHDs) (migraine or non-migraine); and (3) <7 monthly non-migraine headache days.
Exclusion:
- Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Rimegepant
Participants will receive rimegepant 75 mg ODT to administer for the acute treatment of migraine attacks of moderate or severe headache pain intensity. A second rimegepant 75 mg ODT should be taken in the event that participants are not pain free at approximately 2 hours post initial dose OR upon headache relapse after initial pain freedom. The second dose should be taken within 24 hours of the initial dose. Participants will receive rimegepant over a 24 week period during the OLT phase. Participants may redose with rimegepant up to a maximum of 10 times per month (28 days) during the OLT phase. |
Rimegepant |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs), serious TEAEs, and TEAEs leading to study intervention discontinuation on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall
Tidsram: Up to 6 months
|
Up to 6 months
|
|
Incidence of LFT elevations, AST >3x ULN, alanine aminotransferase ALT >3x ULN, and total bilirubin >2x ULN on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall
Tidsram: Up to 6 months
|
Up to 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentage of rimegepant-redosed headache days with satisfaction with headache pain reduction over the entire OLT phase, based on a rating of 'Extremely satisfied' or 'Satisfied' for satisfaction with study intervention to reduce headache pain
Tidsram: Up to 6 months
|
Up to 6 months
|
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Percentage of rimegepant-redosed headache days with reduced impact on daily activities over the entire OLT phase, based on a rating of 'Very good' or 'Good' for the ability of study intervention to reduce the impact of headaches on daily activities
Tidsram: Up to 6 months
|
Up to 6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Pfizer CT.gov Call Center, Pfizer
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C4951086
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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