A Phase 2 interventional study of Sumatriptan 10 mg Nasal Spray and Sumatriptan Placebo Nasal Spray in Migraine Headaches, sponsored by Upsher-Smith Laboratories. Completed at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by Upsher-Smith Laboratories · Phase 2, Interventional, and Treatment
A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 107 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Upsher-Smith Laboratories is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Patients who are willing and able to:
Exclusion Criteria:
Medication overuse:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants self-administered a single-dose of DFN-02 (sumatriptan 10-mg/100 μL nasal spray) intranasally within one hour of an acute migraine pain episode.
Drug: Sumatriptan 10 mg Nasal Spray
Participants self-administered a single-dose of DFN-02 placebo nasal spray matching DFN-02 intranasally within one hour of an acute migraine pain episode.
Other: Sumatriptan Placebo Nasal Spray
100 μL nasal spray once
Also known as: Sumatriptan
100 μL nasal spray once
Number of Participants Free From Headache Pain at 2 Hours After the First Dose of Study Medication Taken for a Migraine Attack With Moderate to Severe Headache Pain During the Double-blind Treatment Period 1 (DB1).
Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \[Grade 2\] or severe \[Grade 3\] predose and reduced to none \[Grade 0\] postdose). Mild headache pain was recorded as Grade 1. 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. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours.
Time frame: 2 hours after study medication administration
Number of Participants With Absence of Most Bothersome Symptom (MBS) Among Nausea, Photophobia and Phonophobia at 2 Hours (DB1)
Number of participants with their MBS among nausea, photophobia and phonophobia absent at 10, 15, 20, 30, 60, 90, and 120 minutes after the first dose of study medication taken for a migraine attack during DB1 treatment period are summarized by treatment group and time point for the full analysis set (FAS1). The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups. Subjects who reported a MBS predose and reported the status of the MBS at the particular postdose time point were analyzed.
Time frame: 2 hours after study medication administration
Number of Participants With Headache Pain Freedom at 2 Hours Postdose in the Double-blind Treatment Period 2 (DB2)
In Double-blind Treatment Period 2 (DB2), freedom from headache pain 2 hours after the first dose of study medication taken within one hour of experiencing a migraine attack for any headache pain level, e.g., mild \[Grade 1\], moderate \[Grade 2\], or severe \[Grade 3\] and reduced to none \[Grade 0\] after study medication administration. 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.
Time frame: 2 hours after study medication administration
The study was conducted in the United States. At least 1 subject was enrolled at 9 study centers.
| Milestone | DFN-02 | Placebo |
|---|---|---|
| Started | 50 | 43 |
| Completed | 48 | 38 |
| Not completed | 2 | 5 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Sponsor terminated | 1 | 0 |
| Withdrew: Lack of diary compliance | 0 | 2 |
| Milestone | DFN-02 | Placebo |
|---|---|---|
| Started | 37 | 38 |
| Completed | 36 | 38 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \[Grade 2\] or severe \[Grade 3\] predose and reduced to none \[Grade 0\] postdose). Mild headache pain was recorded as Grade 1. 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. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours.
| Participants | DFN-02 (DB1) | Placebo (DB1) |
|---|---|---|
| Number of Participants Free From Headache Pain at 2 Hours After the First Dose of Study Medication Taken for a Migraine Attack With Moderate to Severe Headache Pain During the Double-blind Treatment Period 1 (DB1). | 21 | 9 |
Number of participants with their MBS among nausea, photophobia and phonophobia absent at 10, 15, 20, 30, 60, 90, and 120 minutes after the first dose of study medication taken for a migraine attack during DB1 treatment period are summarized by treatment group and time point for the full analysis set (FAS1). The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups. Subjects who reported a MBS predose and reported the status of the MBS at the particular postdose time point were analyzed.
| Participants | DFN-02 (DB1) | Placebo (DB1) |
|---|---|---|
| Number of Participants With Absence of Most Bothersome Symptom (MBS) Among Nausea, Photophobia and Phonophobia at 2 Hours (DB1) | 29 | 15 |
In Double-blind Treatment Period 2 (DB2), freedom from headache pain 2 hours after the first dose of study medication taken within one hour of experiencing a migraine attack for any headache pain level, e.g., mild \[Grade 1\], moderate \[Grade 2\], or severe \[Grade 3\] and reduced to none \[Grade 0\] after study medication administration. 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.
| Participants | DFN-02 (DB2) | Placebo (DB2) |
|---|---|---|
| Number of Participants With Headache Pain Freedom at 2 Hours Postdose in the Double-blind Treatment Period 2 (DB2) | 19 | 17 |
Collected over Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DFN-02 (DB1) | 0/50 (0%) | 0/50 (0%) | 5/50 (10%) |
| Placebo (DB1) | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| DFN-02 (DB2) | 0/37 (0%) | 0/37 (0%) | 5/37 (13.5%) |
| Placebo (DB2) | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Event | DFN-02 (DB1) | Placebo (DB1) | DFN-02 (DB2) | Placebo (DB2) |
|---|---|---|---|---|
| DysgeusiaNervous system disorders | 1/50 | 0/43 | 3/37 | 0/38 |
| Application site painGeneral disorders | 1/50 | 0/43 | 1/37 | 0/38 |
| MalaiseGeneral disorders | 0/50 | 0/43 | 1/37 | 0/38 |
| Ear InfectionInfections and infestations | 0/50 | 0/43 | 1/37 | 0/38 |
| Chest DiscomfortGeneral disorders | 1/50 | 0/43 | 0/37 | 0/38 |
| LacerationInjury, poisoning and procedural complications | 1/50 | 0/43 | 0/37 | 0/38 |
| Burning sensationNervous system disorders | 1/50 | 0/43 | 0/37 | 0/38 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 1/50 | 0/43 | 0/37 | 0/38 |
A maximum 21 day screening period was conducted to evaluate whether a subject met the migraine inclusion criteria pursuant to ICHD-3, and did not exhibit medication overuse. If eligible and randomized, subjects in the DB1 treatment period were instructed to use the study medication for their first migraine attack as soon as (and no more than 1 hour after) experiencing moderate to severe migraine pain. If the subject was missed dosing the first migraine, they were to dose the next attack.
| Age, Continuous(years) | DFN-02 (Double-Blind Treatment Period 1) | Placebo (Double-Blind Treatment Period 1) | Total |
|---|---|---|---|
| Mean | 43.4 (20 to 68) | 41.0 (19 to 63) | 42.3 (19 to 68) |
| Sex: Female, Male(Participants) | DFN-02 (Double-Blind Treatment Period 1) | Placebo (Double-Blind Treatment Period 1) | Total |
|---|---|---|---|
| Female | 38 | 37 | 75 |
| Male | 12 | 6 | 18 |
| Race/Ethnicity, Customized(participants) | DFN-02 (Double-Blind Treatment Period 1) | Placebo (Double-Blind Treatment Period 1) | Total |
|---|---|---|---|
| Asian | 0 | 1 | 1 |
| Black or African American | 5 | 2 | 7 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| White | 42 | 40 | 82 |
| Other | 2 | 0 | 2 |
| Region of Enrollment(participants) | DFN-02 (Double-Blind Treatment Period 1) | Placebo (Double-Blind Treatment Period 1) | Total |
|---|---|---|---|
| United States | 50 | 43 | 93 |
| BMI(kg/m^2) | DFN-02 (Double-Blind Treatment Period 1) | Placebo (Double-Blind Treatment Period 1) | Total |
|---|---|---|---|
| Mean | 27.70 ± 6.441 | 28.80 ± 7.500 | 28.21 ± 6.933 |
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Studies of the drug tested here: Sumatriptan
Upsher-Smith Laboratories