Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-10-06
Brief Title:
A Study to Learn About Zavegepant as a Treatment for Multiple Migraine Attacks in Adult Participants
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN INTERVENTIONAL EFFICACY AND SAFETY PHASE 3 DOUBLE-BLIND 3-ARM STUDY TO INVESTIGATE PAIN RESPONSE WITH INTRANASAL ZAVEGEPANT COMPARED WITH PLACEBO IN THE ACUTE TREATMENT OF MULTIPLE MIGRAINE ATTACKS IN ADULT PARTICIPANTS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study to show that zavegepant 10 milligrams given through the nose provides
freedom from pain 2 hours after taking the medicine for the first migraine attack
consistent freedom from pain 2 hours after taking the medicine across 4 separate migraine attacks
This study is seeking participants who
are 18 years of age or older
have migraine attacks present for at least 1 year with age onset before 50 years old
have migraine attacks on average lasting about 4 to 72 hours if not treated
have 3 to 8 attacks per month but less than15 headache days per month
If the participant is fit to take part in the study the participant will receive either the study medicine zavegepant or placebo A placebo looks like zavegepant but does not contain active ingredients The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo
The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity The participants are expected to treat up to 4 migraines of moderate to severe intensity
After taking the study medicine the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo Participant can take other medicines after the 2 hours if the migraine is still present The participant is expected to record on a paper log all medications taken throughout the study
The study duration is around 26 weeks This includes a 28-day screening window up to 20 weeks of treatment period and a follow up visit at about 4 weeks after taking the study medicine the last time
The participant is expected to come into the study center up to 4 times There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first at Month 3 if the participant is still in the study and a safety follow-up
During the study the participant is expected to complete two sets of questions in an app on a smartphone This step is done before and after taking the study medicine The participants must rate
Pain
Pain symptoms
How the participants are feeling
General well-being
freedom from pain 2 hours after taking the medicine for the first migraine attack
consistent freedom from pain 2 hours after taking the medicine across 4 separate migraine attacks
This study is seeking participants who
are 18 years of age or older
have migraine attacks present for at least 1 year with age onset before 50 years old
have migraine attacks on average lasting about 4 to 72 hours if not treated
have 3 to 8 attacks per month but less than15 headache days per month
If the participant is fit to take part in the study the participant will receive either the study medicine zavegepant or placebo A placebo looks like zavegepant but does not contain active ingredients The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo
The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity The participants are expected to treat up to 4 migraines of moderate to severe intensity
After taking the study medicine the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo Participant can take other medicines after the 2 hours if the migraine is still present The participant is expected to record on a paper log all medications taken throughout the study
The study duration is around 26 weeks This includes a 28-day screening window up to 20 weeks of treatment period and a follow up visit at about 4 weeks after taking the study medicine the last time
The participant is expected to come into the study center up to 4 times There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first at Month 3 if the participant is still in the study and a safety follow-up
During the study the participant is expected to complete two sets of questions in an app on a smartphone This step is done before and after taking the study medicine The participants must rate
Pain
Pain symptoms
How the participants are feeling
General well-being
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505209-17-00 | REGISTRY | CTIS EU | None |