Acute Migraine With or Without Aura
Conditions
Keywords
acute migraine, aura, sumatriptan nasal powder, AVP-825, adolescents
Brief summary
This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants, 12 through 17 years of age.
Detailed description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating AVP-825 for the acute treatment of migraine with or without aura in adolescent subjects (12 to 17 years old).
Interventions
DRUGsumatriptan nasal powder
nasal powder administered via nosepiece
DRUGPlacebo
lactose monohydrate powder administered via nosepiece
Sponsors
Currax Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male and female participants 12 to 17 years (inclusive) of age at the time of informed consent * Have a diagnosis of episodic migraine with or without aura according to International Classification of Headache Disorders-Third edition, beta version (ICHD-IIIB, 1.2.1 or 1.1) criteria, for at least 1 year prior to the screening/enrollment visit * Experienced migraine attacks of moderate-to-severe intensity and typically lasting ≥ 3 hours untreated, occurring at a frequency of ≥ 2 to ≤ 14 attacks per month for the past 6 months prior to the screening/enrollment visit * Participant's parent or legal guardian must be willing to sign a copy of the informed consent form as well as documentation for Written Authorization for Use and Release of Health and Research Study Information, after the nature and risks of study participation have been fully explained. Participants must be willing to provide informed assent.
Exclusion criteria
* Participants with ≥ 15 headache days per month in total (migraine, probable migraine, or tension-type) * Participants with the following headache types: retinal (ICHD-IIIB, 1.2.4), with brainstem aura (ICHD-IIIB, 1.2.2), hemiplegic (ICHD-IIIB, 1.2.3), status migrainosus (ICHD-IIIB, 1.4.1), other forms of complicated migraine, or secondary headaches * Participants who have not responded to an adequate dose and appropriate duration of treatment with 2 or more triptans * Participants with known nasal obstruction, current uncontrolled nasopharyngeal illness, or known velum insufficiency (i.e., a cleft palate and/or structural abnormalities in the soft palate and nasopharynx) that may interfere with the proper use of study medication * Participants whose conditions in the investigator's opinion may put the participant at significant safety risk or confound the study results. This includes participants who in the investigator's opinion should not be enrolled in the study due to the risks described in the Warnings and Precautions or Contraindications sections of the ONZETRA Xsail Prescribing Information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | 120 minutes | Participants will self-report the severity of their headache. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sumatriptan Nasal Powder Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).
sumatriptan nasal powder: nasal powder administered via nosepiece | 79 |
| Placebo Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.
Placebo: lactose monohydrate powder administered via nosepiece | 80 |
| Total | 159 |
Baseline characteristics
| Characteristic | Sumatriptan Nasal Powder | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 79 Participants | 80 Participants | 159 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.4 years | 14.4 years | 14.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 57 Participants | 63 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 17 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 8 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 64 Participants | 69 Participants | 133 Participants |
| Region of Enrollment United States | 79 participants | 80 participants | 159 participants |
| Sex: Female, Male Female | 48 Participants | 42 Participants | 90 Participants |
| Sex: Female, Male Male | 31 Participants | 38 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 79 | 2 / 80 |
| other Total, other adverse events | 3 / 79 | 2 / 80 |
| serious Total, serious adverse events | 0 / 79 | 0 / 80 |
Outcome results
Primary
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment
Participants will self-report the severity of their headache.
Time frame: 120 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sumatriptan Nasal Powder | Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | 8 Participants |
| Placebo | Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | 9 Participants |