Clinical Trials List
Protocol NumberC5301008
NCT Number(ClinicalTrials.gov Identfier)NCT05989048
Completed
2023-09-28 - 2025-10-30
Phase III
Not yet recruiting3
Study ended1
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ZAVEGEPANT INTRANASAL (IN) FOR THE ACUTE TREATMENT OF MIGRAINE IN ASIAN ADULTS
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Sponsor
PFIZER LIMITED
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳世彬 無
- YEN-FENG WANG 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Long-Sun Ro
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Migraine
Objectives
To compare the efficacy of zavegepant with placebo in the acute treatment of migraine.
Test Drug
Zavegepant
Active Ingredient
Zavegepant
Dosage Form
Nasal spray
Dosage
100mg/mL
Endpoints
● Percentage of participants with a pain intensity of none (pain freedom) at 2 hours postdose.
● Percentage of participants with an MBS reported before dosing that is absent at 2 hours postdose.
● Percentage of participants with an MBS reported before dosing that is absent at 2 hours postdose.
Inclution Criteria
1. Asian (based on country of participation and ethnicity status) participants aged 18 years or older at screening.
2. Participants with minimum 1 year history of migraine (with or without aura) prior to
the Screening Visit, consistent with a diagnosis according to the International
Classification of Headache Disorders, 3rd Edition,9
including the following:
‧Migraine attacks present for more than 1 year with the age of onset prior to50 years of age.
‧Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
‧Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months.
‧Participants must be able to distinguish migraine attacks from tension/clusterhead aches.
‧At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
‧Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
‧Participants on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to Screening Visit, and if the dose is not expected to change through the EOT Visit.
‧Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
2. Participants with minimum 1 year history of migraine (with or without aura) prior to
the Screening Visit, consistent with a diagnosis according to the International
Classification of Headache Disorders, 3rd Edition,9
including the following:
‧Migraine attacks present for more than 1 year with the age of onset prior to50 years of age.
‧Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
‧Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months.
‧Participants must be able to distinguish migraine attacks from tension/clusterhead aches.
‧At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
‧Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
‧Participants on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to Screening Visit, and if the dose is not expected to change through the EOT Visit.
‧Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion Criteria
1. History of retinal migraine, basilar migraine or hemiplegic migraine.
2. History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease including:
● Diagnosis of ischemic heart disease, coronary artery vasospasm, and cerebral ischemia during the 6 months prior to Screening Visit.
● Events of MI, ACS, PCI, cardiac surgery, stroke or TIA during the 6 months prior to Screening Visit.
● ECG findings at the Screening Visit including:
o QTcF interval >470 msec. o Left Bundle Branch Block.
o Right Bundle Branch Block with a QRS duration ≥150 msec.
o Intraventricular Conduction Defect with a QRS duration ≥150 msec.
● Uncontrolled hypertension (high blood pressure); a single blood pressure measurement of greater than 150 mmHg systolic or 100 mmHg diastolic after 10 minutes of rest at the Screening Visit is exclusionary.
● Uncontrolled diabetes, defined as HbA1c ≥7.5% at the Screening Visit.
3. Major depressive disorder, anxiety disorder, or other significant psychiatric disorder including:
● Major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit provided the medication is not otherwise prohibited.
● Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics.
● Schizophrenia, bipolar disorder, or borderline personality disorder.
● Response of “yes” to Question 4 or 5 for suicidal ideation, or on any suicidal behavioral question on the C-SSRS for the period of 1 year prior to Screening Visit and during the study, or participants present a serious risk of suicide in the opinion of the investigator.
4. Acute or chronic pain syndromes (such as fibromyalgia, chronic pelvic pain, CRPS). Other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the investigator’s opinion, interfere with study assessments.
5. Conditions that may affect the administration or absorption of the nasal product:
● History of nasal surgery in the 6 months preceding the Screening Visit.
● Evidence at Screening Visit of significant nasal conditions (eg, severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosalerosion or ulceration, polyposis, nasal trauma) as evaluated by the investigator or medically qualified delegate.
● Presence of piercings in the nose that, in the opinion of the investigator, would be likely to interfere with positioning of the unidose nasal spray device and successful completion of the dosing procedure.
6. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or participants who have met DSM-V criteria11 for any significant substance use disorder within the past 12 months from the date of the Screening Visit, or a positive drug screen for drugs of abuse that in the investigator’s judgment is medically significant, in that it would impact the safety of the participant or the interpretation of the study results. In addition:
● Detectable levels of cocaine, amphetamine, and PCP in the drug screen are exclusionary. Participants who are positive for amphetamines, and who are on a prescribed amphetamine medication for an approved indication (ie, ADHD) will be allowed into the study at the investigator’s discretion. This determination by the investigator must be well documented in the participant’s source medical records. The stimulant dose must be stable from 3 months prior to the Baseline Visit and through the EOT Visit.
● Detectable levels of marijuana in the drug screen are not exclusionary, if in the investigator’s documented opinion the participant does not meet DSM-V criteria11 for substance use disorder, and the positive test does not signal a clinical condition that would impact the safety of the participant or interpretation of the study results.
7. Hematologic or solid malignancy diagnosis within 5 years prior to the Screening Visit. Participants with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the Screening Visit in this study.
8. Other social, medical (including drug or other allergy), or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
2. History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease including:
● Diagnosis of ischemic heart disease, coronary artery vasospasm, and cerebral ischemia during the 6 months prior to Screening Visit.
● Events of MI, ACS, PCI, cardiac surgery, stroke or TIA during the 6 months prior to Screening Visit.
● ECG findings at the Screening Visit including:
o QTcF interval >470 msec. o Left Bundle Branch Block.
o Right Bundle Branch Block with a QRS duration ≥150 msec.
o Intraventricular Conduction Defect with a QRS duration ≥150 msec.
● Uncontrolled hypertension (high blood pressure); a single blood pressure measurement of greater than 150 mmHg systolic or 100 mmHg diastolic after 10 minutes of rest at the Screening Visit is exclusionary.
● Uncontrolled diabetes, defined as HbA1c ≥7.5% at the Screening Visit.
3. Major depressive disorder, anxiety disorder, or other significant psychiatric disorder including:
● Major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit provided the medication is not otherwise prohibited.
● Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics.
● Schizophrenia, bipolar disorder, or borderline personality disorder.
● Response of “yes” to Question 4 or 5 for suicidal ideation, or on any suicidal behavioral question on the C-SSRS for the period of 1 year prior to Screening Visit and during the study, or participants present a serious risk of suicide in the opinion of the investigator.
4. Acute or chronic pain syndromes (such as fibromyalgia, chronic pelvic pain, CRPS). Other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the investigator’s opinion, interfere with study assessments.
5. Conditions that may affect the administration or absorption of the nasal product:
● History of nasal surgery in the 6 months preceding the Screening Visit.
● Evidence at Screening Visit of significant nasal conditions (eg, severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosalerosion or ulceration, polyposis, nasal trauma) as evaluated by the investigator or medically qualified delegate.
● Presence of piercings in the nose that, in the opinion of the investigator, would be likely to interfere with positioning of the unidose nasal spray device and successful completion of the dosing procedure.
6. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or participants who have met DSM-V criteria11 for any significant substance use disorder within the past 12 months from the date of the Screening Visit, or a positive drug screen for drugs of abuse that in the investigator’s judgment is medically significant, in that it would impact the safety of the participant or the interpretation of the study results. In addition:
● Detectable levels of cocaine, amphetamine, and PCP in the drug screen are exclusionary. Participants who are positive for amphetamines, and who are on a prescribed amphetamine medication for an approved indication (ie, ADHD) will be allowed into the study at the investigator’s discretion. This determination by the investigator must be well documented in the participant’s source medical records. The stimulant dose must be stable from 3 months prior to the Baseline Visit and through the EOT Visit.
● Detectable levels of marijuana in the drug screen are not exclusionary, if in the investigator’s documented opinion the participant does not meet DSM-V criteria11 for substance use disorder, and the positive test does not signal a clinical condition that would impact the safety of the participant or interpretation of the study results.
7. Hematologic or solid malignancy diagnosis within 5 years prior to the Screening Visit. Participants with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the Screening Visit in this study.
8. Other social, medical (including drug or other allergy), or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
The Estimated Number of Participants
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Taiwan
70 participants
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Global
1400 participants
