Migraine
Conditions
Brief summary
The purpose of this study is to learn how safe and effective zavegepant is compared to placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful headache with other associated symptoms such as nausea, photophobia and phonophobia. A placebo is a harmless treatment that has no medical effect. This study is seeking for participants who: * have at least 1 year of migraine history before entering the study. * have 2 to 8 migraine headache attacks of moderate or severe intensity in each of the 3 months before entering the study. * have less than 15 days with headaches in each of the 3 months before entering the study. The headaches could be either due to migraine or not. The participants in this study will receive zavegepant or placebo through intranasal route. Intranasal means medicine which is given through nose. Zavegepant or placebo will be taken if the participants have a migraine headache of moderate or severe intensity. The study will compare the experiences of people receiving zavegepant to those of the people receiving placebo. This will help see if zavegepant is safe and effective in Asian adults. Participants will be in this study for up to about 16 weeks. Participants will have 3 study visits at the study clinic and 1 through telephone contact.
Interventions
DRUGZavegepant
The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.
DRUGPlacebo
Single dose of matching placebo taken within Treatment Phase.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Asian participants aged 18 years or older at screening. * 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, including the following: 1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age. 2. Migraine attacks, on average, lasting about 4-72 hours if untreated. 3. Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months. 4. Participants must be able to distinguish migraine attacks from tension/cluster headaches. 5. 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). 6. 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). 7. 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 End of Treatment Visit. 8. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion criteria
* History of retinal migraine, basilar migraine or hemiplegic migraine. * History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease. * Major depressive disorder, anxiety disorder, or other significant psychiatric disorder. * Acute or chronic pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that interfere with study assessments. * Conditions that may affect the administration or absorption of the nasal product. * Medication overuse headaches.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pain Freedom at 2 Hours Post-dose | At 2 hours post-dose | Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | At 2 hours post-dose | MBS was selected from nausea, phonophobia or photophobia before dosing by the participants. In this outcome measure, percentage of participants who recorded an MBS (present) before dosing and did not have the MBS (absent) at the time of evaluation (i.e., 2 hours post-dose) were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pain Relief at 15 Minutes Post-dose | At 15 minutes post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). |
| Percentage of Participants With Pain Relief at 30 Minutes Post-dose | At 30 minutes post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | At 2 hours post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). |
| Percentage of Participants Who Returned to Normal Function at 2 Hours Post-dose | At 2 hours post-dose | Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 2 hours post-dose) were reported. |
| Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | From 2 hours post-dose to 24 hours post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 24 hours post-dose with missing data \<=1 time point from 3 to 8 hours post-dose. |
| Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose | From 2 hours post-dose to 48 hours post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 48 hours post-dose with missing data \<=1 time point from 3 to 8 hours post-dose. |
| Percentage of Participants Who Returned to Normal Function at 30 Minutes Post-dose | At 30 minutes post-dose | Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 30 minutes post-dose) were reported. |
| Percentage of Participants Who Returned to Normal Function at 60 Minutes Post-dose | At 60 minutes post-dose | Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 60 minutes post-dose) were reported. |
| Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | At 2 hours post-dose | Freedom from phonophobia was defined as phonophobia absent at specified time point for participants with the phonophobia present at the time of dosing. In this outcome measure, percentage of participants who had phonophobia at the time of dosing and then recorded phonophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported. |
| Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | At 2 hours post-dose | Freedom from photophobia was defined as photophobia absent at specified time point for participants with the photophobia present at the time of dosing. In this outcome measure, percentage of participants who had photophobia at the time of dosing and then recorded photophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported. |
| Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose | At 2 hours post-dose | Freedom from nausea was defined as nausea absent at specified time point for participants with the nausea present at the time of dosing. In this outcome measure, percentage of participants who had nausea at the time of dosing and then recorded nausea absent at time of evaluation (i.e., 2 hours post-dose) were reported. |
| Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose | From 2 hours post-dose to 24 hours post-dose | Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 24 hours post-dose with missing data \<=1 time point from 3 to 8 hours post-dose. |
| Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose | From 2 hours post-dose to 48 hours post-dose | Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 48 hours post-dose with missing data \<=1 time point from 3 to 8 hours post-dose. |
| Percentage of Participants With Pain Relapse at Any Time Point After 2 Hours Post-dose to 48 Hours Post-dose | From after 2 hours post-dose to 48 hours post-dose | Pain relapse was defined as pain intensity of mild, moderate, or severe at any time point after 2 hours to 48 hours post-dose for participants with pain intensity of none at 2 hours post-dose. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). |
| Percentage of Participants Taking Rescue Medication Within 24 Hours Post-dose | Within 24 hours post-dose | Participants who did not experience relief (pain intensity of none or mild) of their migraine headache at the end of 2 hours post-dose, or the migraine was relieved at 2 hours post-dose, but then recurred to a moderate or severe pain intensity level, were permitted to use the following rescue medications: aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug), acetaminophen up to 1000 mg/day (this included Excedrin Migraine), antiemetics (for example, metoclopramide or promethazine), or baclofen. |
| Percentage of Participants With Pain Relief at 60 Minutes Post-dose | At 60 minutes post-dose | Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). |
| Percentage of Participants Who Returned to Normal Function at 15 Minutes Post-dose | At 15 minutes post-dose | Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 15 minutes post-dose) were reported. |
| Number of Participants With Adverse Events (AEs) of Moderate or Severe Intensity: On-Treatment Period | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activity/activities of daily living (ADL), causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention. |
| Number of Participants With AEs of Moderate or Severe Intensity: Follow-up Period | Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual ADL, causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention. |
| Number of Participants With Serious Adverse Events (SAEs): On-Treatment Period | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations. |
| Number of Participants With SAEs: Follow-up Period | Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations. |
| Number of Participants With Local Irritation AEs: On-Treatment Period | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort). |
| Number of Participants With Local Irritation AEs: Follow-up Period | Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort). |
| Number of Participants With Grade 3 to 4 Hematological Test Abnormalities: On-Treatment Period | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | Hematological test abnormalities included: anemia, eosinophilia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophils count decreased, platelet count decreased and white blood cell decreased. Only those hematology test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The hematological test abnormalities grade 3 to 4 were graded according to the common terminology criteria for adverse events (CTCAE) version (v) 5.0. |
| Number of Participants With Grade 3 to 4 Clinical Chemistry Test Abnormalities: On-Treatment Period | On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days | Clinical chemistry test abnormalities included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, creatine phosphokinase (CPK) increased, chronic kidney disease, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia and hyponatremia. Only those clinical chemistry test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The clinical chemistry test abnormalities grade 3 to 4 were graded according to the CTCAE v 5.0. |
Countries
China, South Korea, Taiwan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 39.0 Years STANDARD_DEVIATION 9.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 675 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1353 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 1045 Participants |
| Sex: Female, Male Male | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 678 | 0 / 675 | 0 / 678 | 0 / 675 |
| other Total, other adverse events | 53 / 678 | 23 / 675 | 0 / 678 | 0 / 675 |
| serious Total, serious adverse events | 2 / 678 | 1 / 675 | 3 / 678 | 0 / 675 |
Outcome results
None listed