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| ID | Type | Description | Link |
|---|---|---|---|
| C4951011 | Other Identifier | Alias Study Number |
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The purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.
This is a post marketing required study being conducted to further evaluate the long-term safety and tolerability of a more frequent daily dosing regimen of rimegepant for the prevention of episodic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant | Experimental | rimegepant 75 mg ODT daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | rimegepant ODT 75mg daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in >=5% participants are reported in this OM. | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
| Number of Participants With On-Treatment Serious Adverse Events (SAEs) | An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
| Number of Participants With AEs Leading to Study Drug Discontinuation | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure. | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elite Clinical Studies, LLC | Phoenix | Arizona | 85018 | United States | ||
| Advanced Investigative Medicine, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41366286 | Derived | Antinew J, Fountaine RJ, Loprinzo V, Straghan E, Dubrovin S, DeBesi P, Vatakis N, Fullerton T. A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention. J Headache Pain. 2025 Dec 9;27(1):17. doi: 10.1186/s10194-025-02225-7. |
| 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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Out of the 441 enrolled participants, only 250 received study treatment; 184 participants failed screening, 6 participants were lost to follow-up and 1 participant withdrew consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rimegepant | Participants received a single dose of Rimegepant 75 milligrams (mg) orally disintegrating tablet (ODT) daily for 24 weeks during the open-label treatment phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Treatment Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 17, 2023 | Jul 2, 2025 |
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| Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening). | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
| Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening). | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
| Hawthorne |
| California |
| 90250 |
| United States |
| Velocity Clinical Research - North Hollywood | North Hollywood | California | 91606 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Phoenix Medical Research, LLC | Miami | Florida | 33165 | United States |
| The Headache Clinic | Alexandria | Louisiana | 71301 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| CVS HealthHub - East Brunswick | East Brunswick | New Jersey | 08816 | United States |
| CVS HealthHub - Lawrenceville | Lawrenceville | New Jersey | 08648 | United States |
| CVS HealthHUB - Runnemede | Runnemede | New Jersey | 08078 | United States |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | United States |
| Velocity Clinical Research | Cincinnati | Ohio | 45242 | United States |
| OK Clinical Research, LLC | Edmond | Oklahoma | 73034 | United States |
| Clinical Research Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| VIP Trails | San Antonio | Texas | 78230 | United States |
| VIP Trials | San Antonio | Texas | 78230 | United States |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rimegepant | Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in >=5% participants are reported in this OM. | Safety analysis set included participants in the enrolled analysis set who took greater than or equal to (>=) 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
|
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| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With On-Treatment Serious Adverse Events (SAEs) | An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. | Safety analysis set included participants in the enrolled analysis set who took >= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
|
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| Primary | Number of Participants With AEs Leading to Study Drug Discontinuation | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure. | Safety analysis set included participants in the enrolled analysis set who took >= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening). | Safety analysis set included participants in the enrolled analysis set who took >= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row and "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening). | Safety analysis set included participants in the enrolled analysis set who took >= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row and "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) |
|
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For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment
Safety analysis set included participants in the enrolled analysis set who took >= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rimegepant (On-treatment Period) | Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase. | 0 | 250 | 0 | 250 | 48 | 250 |
| EG001 | Rimegepant (Follow-up Period) | Participants were followed up from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment. | 0 | 235 | 2 | 235 | 2 | 235 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA v27.0MedDRA | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.0MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 13, 2025 | Jul 2, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D012001 | Hyperacusis |
| D020795 | Photophobia |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014786 | Vision Disorders |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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| Not collected |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Participants |
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