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| ID | Type | Description | Link |
|---|---|---|---|
| C5301006 | Other Identifier | Alias Study Number |
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Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
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The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-3500 200mg | Active Comparator | Zavegepant 200mg oral soft gel capsule. |
|
| Placebo 200mg | Placebo Comparator | Matching placebo 200mg oral soft gel capsule. |
|
| BHV-3500 100mg | Active Comparator | Zavegepant 100mg oral soft gel capsule. |
|
| Placebo 100mg | Placebo Comparator | Matching placebo 100mg oral soft gel capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-3500 (zavegepant) | Drug | BHV-3500 (zavegepant) softgel capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12) | A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. >=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. >= 1 of following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28*(total number of migraine days through Month 3[Weeks 1 to 12] in on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3[Weeks 1 to 12] in the on-DBT efficacy analysis period). | Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With >= 50 % Reduction in Number of Moderate to Severe Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12) | A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (>=) 30 minutes, and met at least one of following criteria (A and/or B): A. >=2 of following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. >= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28*(total number of migraine days through Month 3[Weeks 1 to 12] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3[Weeks 1 to 12] in on-DBT efficacy analysis period). |
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Inclusion Criteria:
Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of
Headache Disorders, 3rd Edition, including the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xenoscience, Inc | Phoenix | Arizona | 85004 | United States | ||
| Tucson Neuroscience Research |
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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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The study enrolled 1753 participants, out of which 1219 were not randomized. Only 534 participants were randomized in a 12-week double-blind treatment (DBT) phase. A total of 298 eligible participants then entered in a 52-week open-label extension (OLE) phase. Participants had a follow-up of 8 weeks after discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zavegepant 100 mg (OLE/DBT) | Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg *4 capsules) daily for 12 weeks in DBT phase. Eligible participants continued to receive Zavegepant in similar manner for another 52 weeks in OLE phase. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: DBT 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 | May 16, 2022 | Mar 6, 2025 |
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| Placebo | Drug | Matching placebo softgel capsule. |
|
| Entire DBT Phase: 12 weeks (Week 1 through 12) |
| Mean Change From Observation Phase in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase | A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for greater than or equal to (>=) 30 minutes, and met at least one of the following criteria (A and/or B): A.>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. >= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28* (total number of migraine days in the month[Week 9 to 12])/(total number of eDiary efficacy data days in the month[Week 9 to 12]). | Observation Phase: 28 days prior to randomization and baseline; DBT Phase: last 4 weeks (Week 9 through 12) |
| Mean Change From Observation Phase in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase | A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for greater than or equal to (>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. >=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. >= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in the on-DBT efficacy analysis period as follows: 28* (total number of migraine days in the month[Week 1 to 4])/ (total number of eDiary efficacy data days in the month[Week 1 to 4]). | Observation Phase: 28 days prior to randomization and baseline; DBT Phase: first 4 weeks (Week 1 through 4) |
| Mean Number of Acute Migraine -Specific Medication Days Per Month Over Entire DBT Phase (Weeks 1 to 12) | Acute migraine (AM)-specific medication day was defined as any calendar day on which the participant took an acute migraine-specific medication during aura or to treat a headache. Acute migraine-specific medications were triptans and ergotamine. The number of acute migraine-specific medication days per month were prorated to 28 days and derived as follows: 28 * (total number of acute migraine-specific medication days through Month 3 [Week 1 to 12] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3 [Week 1 to 12] in the on-DBT efficacy analysis period). | Entire DBT Phase: 12 weeks (Week 1 through 12) |
| Mean Change From Baseline in the Migraine-specific Quality of Life Questionnaire (MSQ) v 2.1 Restrictive Role Function Domain Score at Week 12 | MSQ v 2.1 is 14-item questionnaire that assessed impact of treatment on participant-reported quality of life across 3 domains: role function-restrictive, preventive, and emotional function. Restrictive role function domain consists of 7 items that describe how migraine limits one's daily social, work-related activities. Participants respond to items using a 6-point scale ranging from 1 (none of the time) to 6 (all of the time), which are assigned scores of 1 to 6, respectively. Response from each item of restrictive role function domain were added providing a possible raw score range of 7 (no impairment) to 42 (maximum impairment). Raw score range of restrictive role function domain was then transformed to a 0 (no impairment) to 100 (maximum impairment), higher scores = higher impairment. | DBT Phase: Baseline (before dose on Day 1), Week 12 |
| Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 | MIDAS is a retrospective, participant-reported, 5-item questionnaire that measured headache related disability as lost days due to headache from paid work or school, household work and non-work activities over past 3-months. The total score is calculated as the sum of item scores to all 5 questions on a scale of 0 (no disability) to 90 (maximum disability) resulting into overall possible MIDAS total score (range from 0 (no disability) to 450 (maximum disability). Higher scores = more severe disability. | DBT Phase: Baseline (before dose on Day 1), Week 12 |
| Number of Participants With Moderate or Severe Adverse Events (AEs): DBT Phase | AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention. | DBT Phase: During 12 weeks of treatment |
| Number of Participants With Serious Adverse Events (SAEs): DBT Phase | AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. | DBT Phase: During 12 weeks of treatment |
| Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | DBT Phase: During 12 weeks of treatment |
| Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase | Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling. | DBT: During 12 weeks of treatment |
| Number of Participants With Moderate or Severe AEs: OLE Phase | AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention. | OLE: During 52 weeks of treatment |
| Number of Participants With SAEs: OLE Phase | AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. | OLE: During 52 weeks of treatment |
| Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | OLE: During 52 weeks of treatment |
| Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase | Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling. | OLE: During 52 weeks of treatment |
| Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: DBT Phase | Elevations of AST or alanine aminotransferase (ALT) > 3 *upper limit of normal (ULN) concurrent with total bilirubin (TBL) > 2 *ULN (elevations on the same laboratory collection date) were included. | DBT: Over 12 weeks of treatment |
| Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: OLE Phase | Elevations of AST or ALT > 3 * ULN concurrent with TBL > 2 *ULN were defined as elevations on the same collection date. | OLE: Over 52 weeks of treatment |
| Number of Participants With Hepatic-related AEs by Intensity: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention. | DBT Phase: During 12 weeks of treatment |
| Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | DBT Phase: During 12 weeks of treatment |
| Number of Participants With Hepatic-related AEs by Intensity: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention. | OLE: Over 52 weeks of treatment |
| Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | OLE: Over 52 weeks of treatment |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Hope Clinical Research | Canoga Park | California | 91303 | United States |
| Axiom Research, Llc | Colton | California | 92324 | United States |
| Wr-Pri, Llc | Encino | California | 91316 | United States |
| eStudySite | La Mesa | California | 91942 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Collaborative Neuroscience Research, LLC. | Long Beach | California | 90806 | United States |
| Clinical Research Institute | Los Angeles | California | 90048 | United States |
| Wr-Pri, Llc | Newport Beach | California | 92660 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| California Neuroscience Research Medical Group, inc. | Sherman Oaks | California | 91403 | United States |
| CMR of Greater New Haven, LLC | Hamden | Connecticut | 06517 | United States |
| Ki Health Partners, LLc, dba New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Neurology Offices of South Florida | Boca Raton | Florida | 33428 | United States |
| Accel Research Sites Network - Edgewater Clinical Research Unit | Edgewater | Florida | 32132 | United States |
| Complete Health Research | Edgewater | Florida | 32132 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Multi-Specialty Research Associates, Inc. | Lake City | Florida | 32055 | United States |
| AppleMed Research Group, LLC | Miami | Florida | 33126 | United States |
| AppleMed Research Group, LLC | Miami | Florida | 33155 | United States |
| Brainstorm Research | Miami | Florida | 33176 | United States |
| The Neurology Research Group | Miami | Florida | 33176 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Complete Health Research | Ormond Beach | Florida | 32174 | United States |
| Ideal Clinical Research | Pembroke Pines | Florida | 33026 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| Clin-Med Research & Development LLC | South Miami | Florida | 33143 | United States |
| Accel Research Sites Network - St. Petersburg Clinical Research Unit | St. Petersburg | Florida | 33709 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| JSV Clinical Research Study Inc | Tampa | Florida | 33634 | United States |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | United States |
| iResearch Atlanta LLC | Decatur | Georgia | 30030 | United States |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Clinical Investigation Specialists, Inc. | Gurnee | Illinois | 60031 | United States |
| Clinical Investigation Specialists, Inc | Gurnee | Illinois | 60031 | United States |
| MediSphere Medical Research Center, LLC. | Evansville | Indiana | 47714 | United States |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| Meridian Clinical Research, LLC | Sioux City | Iowa | 51106 | United States |
| Alliance for Multispecialty Reseach, LLC | El Dorado | Kansas | 67042 | United States |
| Alliance for Multispecialty Research, LLC | Newton | Kansas | 67114 | United States |
| Collevtive Medical Research | Overland Park | Kansas | 66210 | United States |
| Kansas Institute of Research | Overland Park | Kansas | 66211 | United States |
| The Research Group of Lexington, Llc. | Lexington | Kentucky | 40503 | United States |
| The Research Group of Lexington, Llc | Lexington | Kentucky | 40503 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Crescent City Headache and Neurology Center | Chalmette | Louisiana | 70043 | United States |
| Alliance for Multispecialty Research, LLC. | New Orleans | Louisiana | 70119 | United States |
| DelRicht Research | New Orleans | Louisiana | 70124 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Neurology Center of New England P.C. | Foxborough | Massachusetts | 02035 | United States |
| Community Clinical Research Network Inc | Marlborough | Massachusetts | 01752 | United States |
| MedVadis Research Corporation | Waltham | Massachusetts | 02451 | United States |
| Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Romedica LLC | Rochester | Michigan | 48307 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Alliance for Multispecialty Reseach, LLC | Kansas City | Missouri | 64114 | United States |
| Clinvest Research, LLC | Springfield | Missouri | 65807 | United States |
| Clinvest Research, LLC | Springfield | Missouri | 65810 | United States |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | United States |
| Excel Clinical research | Las Vegas | Nevada | 89109 | United States |
| Wr-Crcn, Llc | Las Vegas | Nevada | 89118 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Dent Neurosciences Research Center, Inc. | Amherst | New York | 14226 | United States |
| Central New York Clinical Research | Manlius | New York | 13104 | United States |
| New York Neurology Associates | New York | New York | 10003 | United States |
| Fieve Clinical Research, Inc | New York | New York | 10017 | United States |
| North Suffolk Neurology, PC | Port Jefferson Station | New York | 11776 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Upstate Clinical Research Associates, LLC | Williamsville | New York | 14221 | United States |
| Headache Wellness Center | Greensboro | North Carolina | 27405 | United States |
| Accellacare | Raleigh | North Carolina | 27609 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| Carolina Research Center, Inc. | Shelby | North Carolina | 28150 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| WellNow Urgent Care and Research | Cincinnati | Ohio | 45215 | United States |
| Wellnow Urgent Care | Cincinnati | Ohio | 45215 | United States |
| Hometown Urgent Care and Research | Columbus | Ohio | 43214 | United States |
| Wellnow Urgent Care and Research | Columbus | Ohio | 43214 | United States |
| Hometown Urgent Care and Research | Dayton | Ohio | 45424 | United States |
| WellNow Urgent Care and Research | Dayton | Ohio | 45424 | United States |
| Neuro-Behavioral Clinical Research, Inc. | North Canton | Ohio | 44720 | United States |
| WellNow Urgent Care and Research | Troy | Ohio | 45373 | United States |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | United States |
| Hightower Clinical | Oklahoma City | Oklahoma | 73134 | United States |
| Summit Headlands LLC, dba Summit Research | Portland | Oregon | 97210 | United States |
| Clinical Research Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| Preferred Primary Care Physicians, Inc. | Pittsburgh | Pennsylvania | 15236 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | United States |
| Reading Hospital Clinical Trials Office | West Reading | Pennsylvania | 19611 | United States |
| Tower Health Medical Group - Neurology | West Reading | Pennsylvania | 19611 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Accellacare (Administrative Only) | Bristol | Tennessee | 37620 | United States |
| Internal Medicine and Pediatric Associates of Bristol, PC | Bristol | Tennessee | 37620 | United States |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| KCA Neurology, PLLC | Franklin | Tennessee | 37067 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| North Texas Institute of Neurology and Headache - NextStage Clinical Research | Frisco | Texas | 75034 | United States |
| North Texas Institute of Neurology and Headache | Frisco | Texas | 75034 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Red Star Research. LLC | Lake Jackson | Texas | 77566 | United States |
| FMC Science | Lampasas | Texas | 76550 | United States |
| Radiance Clinical Research | Lampasas | Texas | 76550 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Wasatch Clinical Research , LLC(Administrative Location) | Salt Lake City | Utah | 84107 | United States |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | United States |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | United States |
| Meridian Clinical Research, LLC | Norfolk | Virginia | 23502 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Seattle Clinical Research Center | Seattle | Washington | 98105 | United States |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98105 | United States |
| Zavegepant 200 mg (OLE/DBT) |
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. Eligible participants continued to receive Zavegepant in similar manner for another 52 weeks in OLE phase. |
| FG002 | Placebo (DBT)/ Zavegepant 100 mg (OLE) | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. Eligible participants received Zavegepant 100 mg orally as soft gelatin capsules (25 mg *4 capsules) daily for 52 weeks in OLE phase. |
| FG003 | Placebo (DBT)/ Zavegepant 200 mg (OLE) | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. Eligible participants received Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 52 weeks in OLE phase. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2: OLE Phase |
|
|
| Period 3: Follow-up Phase |
|
|
DBT safety analysis set included participants in the safety analysis set who took greater than or equal to (>=) 1 dose of DB study drug (zavegepant or placebo), i.e., nonmissing DB study drug start date.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zavegepant 100 mg (DBT) | Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg *4 capsules) daily for 12 weeks in DBT phase. |
| BG001 | Zavegepant 200 mg (DBT) | Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. |
| BG002 | Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. |
| BG003 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. |
| BG004 | Total | Total of all reporting groups |
| 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12) | A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. >=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. >= 1 of following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28*(total number of migraine days through Month 3[Weeks 1 to 12] in on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3[Weeks 1 to 12] in the on-DBT efficacy analysis period). | Migraine analysis set included participants in the DBT efficacy analysis set with >= 14 days of e-diary efficacy data in both the observation phase and >= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took >=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ statistical analysis plan (SAP). | Posted | Least Squares Mean | 97.5% Confidence Interval | Migraine Days per Month | Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12) |
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| Secondary | Percentage of Participants With >= 50 % Reduction in Number of Moderate to Severe Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12) | A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (>=) 30 minutes, and met at least one of following criteria (A and/or B): A. >=2 of following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. >= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28*(total number of migraine days through Month 3[Weeks 1 to 12] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3[Weeks 1 to 12] in on-DBT efficacy analysis period). | Migraine analysis set included participants in the DBT efficacy analysis set with >= 14 days of e-diary efficacy data in both the observation phase and >= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took >=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP. | Posted | Number | 97.5% Confidence Interval | Percentage of participants | Entire DBT Phase: 12 weeks (Week 1 through 12) |
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| Secondary | Mean Change From Observation Phase in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase | A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for greater than or equal to (>=) 30 minutes, and met at least one of the following criteria (A and/or B): A.>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. >= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28* (total number of migraine days in the month[Week 9 to 12])/(total number of eDiary efficacy data days in the month[Week 9 to 12]). | Migraine analysis set analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP. | Posted | Least Squares Mean | 97.5% Confidence Interval | Migraine Days per Month | Observation Phase: 28 days prior to randomization and baseline; DBT Phase: last 4 weeks (Week 9 through 12) |
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| Secondary | Mean Change From Observation Phase in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase | A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for greater than or equal to (>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. >=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. >= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in the on-DBT efficacy analysis period as follows: 28* (total number of migraine days in the month[Week 1 to 4])/ (total number of eDiary efficacy data days in the month[Week 1 to 4]). | Migraine analysis set analyzed. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 97.5% Confidence Interval | Migraine Days per Month | Observation Phase: 28 days prior to randomization and baseline; DBT Phase: first 4 weeks (Week 1 through 4) |
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| Secondary | Mean Number of Acute Migraine -Specific Medication Days Per Month Over Entire DBT Phase (Weeks 1 to 12) | Acute migraine (AM)-specific medication day was defined as any calendar day on which the participant took an acute migraine-specific medication during aura or to treat a headache. Acute migraine-specific medications were triptans and ergotamine. The number of acute migraine-specific medication days per month were prorated to 28 days and derived as follows: 28 * (total number of acute migraine-specific medication days through Month 3 [Week 1 to 12] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3 [Week 1 to 12] in the on-DBT efficacy analysis period). | Migraine analysis set included participants in the DBT efficacy analysis set with >= 14 days of e-diary efficacy data in both the observation phase and >= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took >=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP. | Posted | Least Squares Mean | 97.5% Confidence Interval | AM-specific Medication Days per Month | Entire DBT Phase: 12 weeks (Week 1 through 12) |
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| Secondary | Mean Change From Baseline in the Migraine-specific Quality of Life Questionnaire (MSQ) v 2.1 Restrictive Role Function Domain Score at Week 12 | MSQ v 2.1 is 14-item questionnaire that assessed impact of treatment on participant-reported quality of life across 3 domains: role function-restrictive, preventive, and emotional function. Restrictive role function domain consists of 7 items that describe how migraine limits one's daily social, work-related activities. Participants respond to items using a 6-point scale ranging from 1 (none of the time) to 6 (all of the time), which are assigned scores of 1 to 6, respectively. Response from each item of restrictive role function domain were added providing a possible raw score range of 7 (no impairment) to 42 (maximum impairment). Raw score range of restrictive role function domain was then transformed to a 0 (no impairment) to 100 (maximum impairment), higher scores = higher impairment. | DBT efficacy analysis set included participants in the full analysis set who were randomized only once and took >= 1 dose of DB study drug (zavegepant or placebo). Here, " Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP. | Posted | Least Squares Mean | 97.5% Confidence Interval | Scores on a scale | DBT Phase: Baseline (before dose on Day 1), Week 12 |
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| Secondary | Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 | MIDAS is a retrospective, participant-reported, 5-item questionnaire that measured headache related disability as lost days due to headache from paid work or school, household work and non-work activities over past 3-months. The total score is calculated as the sum of item scores to all 5 questions on a scale of 0 (no disability) to 90 (maximum disability) resulting into overall possible MIDAS total score (range from 0 (no disability) to 450 (maximum disability). Higher scores = more severe disability. | DBT efficacy analysis set included participants in the full analysis set who were randomized only once and took >= 1 dose of DB study drug (zavegepant or placebo). Here, " Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP. | Posted | Least Squares Mean | 97.5% Confidence Interval | Scores on a scale | DBT Phase: Baseline (before dose on Day 1), Week 12 |
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| Secondary | Number of Participants With Moderate or Severe Adverse Events (AEs): DBT Phase | AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention. | DBT safety analysis set included the participants who were enrolled and took >= 1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. | Posted | Count of Participants | Participants | DBT Phase: During 12 weeks of treatment |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs): DBT Phase | AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. | DBT safety analysis set included the participants who were enrolled and took >= 1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. | Posted | Count of Participants | Participants | DBT Phase: During 12 weeks of treatment |
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| Secondary | Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | DBT safety analysis set included the participants in the who were enrolled and who took >=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. | Posted | Count of Participants | Participants | DBT Phase: During 12 weeks of treatment |
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| Secondary | Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase | Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling. | DBT safety analysis set included the participants in the who were enrolled and who took >=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. Participants reported under "Overall Number of Participants Analyzed" contributed data but may not be evaluable for every row and "Number Analyzed" signifies participants evaluable for the specified rows. | Posted | Count of Participants | Participants | DBT: During 12 weeks of treatment |
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| Secondary | Number of Participants With Moderate or Severe AEs: OLE Phase | AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention. | OL safety analysis set included the participants who took >= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. | Posted | Count of Participants | Participants | OLE: During 52 weeks of treatment |
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| Secondary | Number of Participants With SAEs: OLE Phase | AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. | OL safety analysis set included the participants who took >= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. | Posted | Count of Participants | Participants | OLE: During 52 weeks of treatment |
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| Secondary | Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | OL safety analysis set included the participants who took >= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. | Posted | Count of Participants | Participants | OLE: During 52 weeks of treatment |
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| Secondary | Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase | Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling. | OL safety analysis set included the participants who took >= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. Here, "Number Analyzed" signifies participants evaluable for the specified rows. "Overall Number of Participants Analyzed" contributed data to table but may not have evaluable data for every row. | Posted | Count of Participants | Participants | OLE: During 52 weeks of treatment |
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| Secondary | Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: DBT Phase | Elevations of AST or alanine aminotransferase (ALT) > 3 *upper limit of normal (ULN) concurrent with total bilirubin (TBL) > 2 *ULN (elevations on the same laboratory collection date) were included. | DBT safety analysis set included the participants in the who were enrolled and who took >=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. | Posted | Number | 97.5% Confidence Interval | Percentage of participants | DBT: Over 12 weeks of treatment |
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| Secondary | Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: OLE Phase | Elevations of AST or ALT > 3 * ULN concurrent with TBL > 2 *ULN were defined as elevations on the same collection date. | OL safety analysis set included the participants who took >= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. | Posted | Number | 97.5% Confidence Interval | Percentage of participants | OLE: Over 52 weeks of treatment |
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| Secondary | Number of Participants With Hepatic-related AEs by Intensity: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention. | DBT safety analysis set included the participants in the who were enrolled and who took >=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. | Posted | Count of Participants | Participants | DBT Phase: During 12 weeks of treatment |
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| Secondary | Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | DBT safety analysis set included the participants in the who were enrolled and who took >=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. | Posted | Count of Participants | Participants | DBT Phase: During 12 weeks of treatment |
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| Secondary | Number of Participants With Hepatic-related AEs by Intensity: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention. | OL safety analysis set included the participants who took >= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. | Posted | Count of Participants | Participants | OLE: Over 52 weeks of treatment |
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| Secondary | Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | OL safety analysis set included the participants who took >= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. | Posted | Count of Participants | Participants | OLE: Over 52 weeks of treatment |
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DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zavegepant 100 mg (DBT) | Participants were randomized to receive Zavegepant 100 mg orally as soft gelatin capsules (25 mg *4 capsules) daily for 12 weeks in DBT phase. | 1 | 173 | 1 | 173 | 14 | 173 |
| EG001 | Zavegepant 200 mg (DBT) | Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. | 0 | 175 | 1 | 175 | 8 | 175 |
| EG002 | Zavegepant Pooled (DBT) | Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. | 0 | 348 | 2 | 348 | 22 | 348 |
| EG003 | Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. | 0 | 86 | 0 | 86 | 13 | 86 |
| EG004 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. | 0 | 88 | 1 | 88 | 11 | 88 |
| EG005 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. | 0 | 174 | 1 | 174 | 24 | 174 |
| EG006 | Zavegepant 100 mg (OLE) | Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg *4 capsules) daily for 52 weeks in OLE phase. | 0 | 155 | 1 | 155 | 12 | 155 |
| EG007 | Zavegepant 200 mg (OLE) | Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 52 weeks in OLE phase. | 0 | 143 | 3 | 143 | 12 | 143 |
| EG008 | Zavegepant 100 mg DBT/Zavegepant 100 mg OLE: Follow-up | Participants who received Zavegepant 100 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase. | 0 | 154 | 0 | 154 | 0 | 154 |
| EG009 | Zavegepant 200 mg DBT/ Zavegepant 200 mg OLE: Follow-up | Participants who received Zavegepant 200 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase. | 0 | 162 | 1 | 162 | 0 | 162 |
| EG010 | Placebo Matched to Zavegepant 100 mg (DBT)/ Zavegepant 100 mg OLE: Follow-up | Participants who received Placebo matched to Zavegepant 100 mg in DBT phase or Placebo matched to Zavegepant 100 mg in DBT phase and Zavegepant 100 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase. | 0 | 47 | 1 | 47 | 0 | 47 |
| EG011 | Placebo Matched to Zavegepant 200 mg (DBT)/ Zavegepant 200 mg OLE: Follow-up | Participants who received Placebo matched to Zavegepant 200 mg in DBT phase or Placebo matched to Zavegepant 200 mg in DBT phase and Zavegepant 200 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase. | 0 | 48 | 0 | 48 | 0 | 48 |
| EG012 | Placebo Pooled (DBT)/No Zavegepant OLE: Follow-up | Participants who received Placebo matched to Zavegepant 100 mg or 200 mg in DBT phase and no Zavegepant in OLE phase were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT phase. | 0 | 70 | 0 | 70 | 0 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA27.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA27.0 | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA27.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA27.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA27.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA27.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA27.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA27.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA27.0 | Non-systematic Assessment |
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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 | May 30, 2024 | Mar 6, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D012001 | Hyperacusis |
| D020795 | Photophobia |
| D009325 | Nausea |
| 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 |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
| Lost to Follow-up |
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| Non-compliance |
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| Other |
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| Physician Decision |
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| Pregnancy |
|
| Study terminated by sponsor |
|
| Withdrawal by Subject |
|
| Not reported |
|
| Failure to meet continuation criteria |
|
| Other |
|
| Withdrawal by Subject |
|
| Not reported |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Difference in LSM |
| -0.7 |
| 2-Sided |
| 97.5 |
| -2.07 |
| 0.69 |
Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set. |
| Other |
Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg *4 capsules) daily for 12 weeks in DBT phase. |
| OG001 | Zavegepant 200 mg (DBT) | Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. |
| OG002 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
|
| OG001 | Zavegepant 200 mg (DBT) | Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. |
| OG002 | Placebo Pooled | Participants received 100 mg and 200 mg daily dose of 4 oral soft gel capsules for up to 52-weeks. |
|
|
|
| OG001 | Zavegepant 200 mg (DBT) | Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. |
| OG002 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
|
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. |
| OG002 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
|
| OG001 | Zavegepant 200 mg (DBT) | Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. |
| OG002 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
|
| OG002 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
|
| Zavegepant Pooled (DBT) |
Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
| OG003 | Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. |
| OG004 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. |
| OG005 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
| OG002 | Zavegepant Pooled (DBT) | Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
| OG003 | Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. |
| OG004 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. |
| OG005 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
| OG003 | Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. |
| OG004 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. |
| OG005 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
| OG001 |
| Zavegepant 200 mg (DBT) |
Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 12 weeks in DBT phase. |
| OG002 | Zavegepant Pooled (DBT) | Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
| OG003 | Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. |
| OG004 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. |
| OG005 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg *8 capsules) daily for 52 weeks in OLE phase. |
|
|
| OG003 |
| Placebo (DBT) Matched to Zavegepant 100 mg |
Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. |
| OG004 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. |
| OG005 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
|
| OG002 | Zavegepant Pooled (DBT) | Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
| OG003 | Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. |
| OG004 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. |
| OG005 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
|
|
| OG003 | Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. |
| OG004 | Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. |
| OG005 | Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. |
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