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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.
To evaluate the safety and tolerability of rimegepant 75 mg ODT when redosed due to residual pain or headache relapse
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | Rimegepant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 months | |
| 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 |
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Inclusion:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Clinical Research | Recruiting | Canoga Park | California | 91303 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| Up to 6 months |
| Neurology Offices of South Florida |
| Recruiting |
| Boca Raton |
| Florida |
| 33428 |
| United States |
| Brainstorm Research | Recruiting | Miami | Florida | 33176 | United States |
| Clinical Neuroscience Solutions | Recruiting | Orlando | Florida | 32801 | United States |
| New England Regional Headache Center | Recruiting | Worcester | Massachusetts | 01609 | United States |
| Michigan Headache & Neurological Institute | Not yet recruiting | Ann Arbor | Michigan | 48104 | United States |
| FutureSearch Trials of Dallas | Not yet recruiting | Dallas | Texas | 75251 | United States |
| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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