Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT02856802
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)
Sponsor:
Upsher-Smith Laboratories
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of DFN-02 in Episodic Migraine With or Without Aura
Status:
COMPLETED
Status Verified Date:
2020-12
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:
A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.
Detailed Description:
This was a randomized, two double-blind (DB) treatment period dosing study.
Previously diagnosed subjects with a history of episodic migraine (as defined by International Classification of Headache Disorders (ICHD), 3rd edition \[beta version\] \[ICHD 3\]) who experienced an average of 2 to 8 migraine attacks per month for at least the prior 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine, were randomized in a 1:1 ratio in both DB periods to receive either DFN-02 (sumatriptan nasal spray 10 mg) or a matching placebo.
Subjects treated one moderate to severe migraine attack in the first double-blind treatment period (DB1) and, if eligible, were re-randomized into the second double-blind treatment period (DB2) to treat another migraine attack at any pain level.
There was a screening period of up to 21 days to evaluate whether subjects fit the migraine inclusion criteria pursuant to ICHD-3, and did not have medication overuse. Subjects with at least a 12 month medical history of acute migraine were eligible for enrollment in the treatment period. Subjects continued to take their normal migraine medication during this screening period.
If eligible and randomized, subjects in the DB1 treatment period were instructed to use the study medication in one migraine attack as soon as (and no more than within one hour after) experiencing moderate to severe migraine pain (defined as headache pain rating of Grade 2 \[moderate\] or Grade 3 \[severe\] on a pain severity scale of 0 to 3). If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. Those subjects who did not experience a migraine attack, and/or did not treat any migraine attack with study medication or record diary data, were not allowed to continue into the DB2 treatment period, and were discontinued.
After treating a migraine attack with study medication, subjects were instructed to contact the site within 24 hours of the treated migraine (or the next working day) to schedule their next visit.
Subjects returned to the study site within 2 to 7 days in the DB1 treatment period and, if continuing to be eligible, were re-randomized into a DB2 treatment period to treat one migraine attack at any pain level, and return to the study site within 2 to 7 days of the second treatment.
Once randomized, the total duration of each subject's participation in the study was up to 10 weeks.
Previously diagnosed subjects with a history of episodic migraine (as defined by International Classification of Headache Disorders (ICHD), 3rd edition \[beta version\] \[ICHD 3\]) who experienced an average of 2 to 8 migraine attacks per month for at least the prior 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine, were randomized in a 1:1 ratio in both DB periods to receive either DFN-02 (sumatriptan nasal spray 10 mg) or a matching placebo.
Subjects treated one moderate to severe migraine attack in the first double-blind treatment period (DB1) and, if eligible, were re-randomized into the second double-blind treatment period (DB2) to treat another migraine attack at any pain level.
There was a screening period of up to 21 days to evaluate whether subjects fit the migraine inclusion criteria pursuant to ICHD-3, and did not have medication overuse. Subjects with at least a 12 month medical history of acute migraine were eligible for enrollment in the treatment period. Subjects continued to take their normal migraine medication during this screening period.
If eligible and randomized, subjects in the DB1 treatment period were instructed to use the study medication in one migraine attack as soon as (and no more than within one hour after) experiencing moderate to severe migraine pain (defined as headache pain rating of Grade 2 \[moderate\] or Grade 3 \[severe\] on a pain severity scale of 0 to 3). If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. Those subjects who did not experience a migraine attack, and/or did not treat any migraine attack with study medication or record diary data, were not allowed to continue into the DB2 treatment period, and were discontinued.
After treating a migraine attack with study medication, subjects were instructed to contact the site within 24 hours of the treated migraine (or the next working day) to schedule their next visit.
Subjects returned to the study site within 2 to 7 days in the DB1 treatment period and, if continuing to be eligible, were re-randomized into a DB2 treatment period to treat one migraine attack at any pain level, and return to the study site within 2 to 7 days of the second treatment.
Once randomized, the total duration of each subject's participation in the study was up to 10 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: