Phase 3
Completed N=275
Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura
Migraine · Headaches
Source: ClinicalTrials.gov NCT01667679 ↗
Enrolled (actual)
275
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Mean Sum of Migraine Pain Intensity Differences (SPID)-30 — 10.80; 7.41 scores on a scale — p=<0.0001
◆ Published Evidence
Established
54citations · ~5 / year
AVP-825 breath-powered intranasal delivery system containing 22 mg sumatriptan powder vs 100 mg oral sumatriptan in the acute treatment of migraines (The COMPASS study): a comparative randomized clinical trial across multiple attacks.
Summary
This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine headaches in 30 minutes after use.
Linked Publications (2)
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AVP-825 breath-powered intranasal delivery system containing 22 mg sumatriptan powder vs 100 mg oral sumatriptan in the acute treatment of migraines (The COMPASS study): a comparative randomized clinical trial across multiple attacks.
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Faster Improvement in Migraine Pain Intensity and Migraine-Related Disability at Early Time Points with AVP-825 (Sumatriptan Nasal Powder Delivery System) versus Oral Sumatriptan: A Comparative Randomized Clinical Trial Across Multiple Attacks from the COMPASS Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Sum of Migraine Pain Intensity Differences (SPID)-30 |
10.80; 7.41 | <0.0001 sig |
| SECONDARY Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe |
3.90; 0.24; 13.83; 10.07 | 0.0013 sig |
| SECONDARY Percentage of Attacks in Which Pain Reduction Was Achieved |
11.5; 10.2; 26.4; 19.6; 49.0; 35.2 | 0.3549 |
| SECONDARY Percentage of Attacks in Which Pain Freedom Was Achieved |
2.5; 1.3; 7.2; 3.7; 18.2; 10.8 | 0.1771 |
| SECONDARY Percentage of Attacks in Which Pain Relief Was Achieved |
13.8; 11.5; 27.9; 20.9; 53.8; 38.7 | 0.2426 |
| SECONDARY Median Time to Pain Freedom |
91; 121 | — |
| SECONDARY Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose |
-0.11; -0.09; -0.26; -0.18; -0.56; -0.38 | 0.3562 |
| SECONDARY Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose |
-0.08; -0.03; -0.18; -0.09; -0.42; -0.26 | 0.0181 sig |
| SECONDARY Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event |
118; 73; 0; 0 | — |
| SECONDARY Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks) |
-1.3; -1.3; -2.7; -0.8 | — |
| SECONDARY Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks) |
-0.002; -0.005; -0.005; -0.002 | — |
| SECONDARY Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
-0.02; -0.04; -0.05; -0.02 | — |
| SECONDARY Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
-0.10; -0.19; -0.05; -0.09; 0.000; 0.000 | — |
| SECONDARY Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
0.070; 0.079; 0.156; 0.308 | — |
| SECONDARY Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
-1.9; -0.7; -1.3; -0.6 | — |
| SECONDARY Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
-0.5; 0.0; -1.7; -1.0; 0.4; 0.0 | — |
| SECONDARY Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
-0.2; 0.5; 0.6; -1.2; 0.8; 0.0 | — |
| SECONDARY Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
0.2; -0.2; -0.6; 0.2 | — |
| SECONDARY Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
-0.8; -0.9; -0.9; -0.5; -1.0; -1.2 | — |
| SECONDARY Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
-0.3; -0.5; -0.3; -0.2; -0.08; -0.04 | — |
| SECONDARY Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
-0.04; -0.03; 0.01; -0.07 | — |
| SECONDARY Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24) |
112; 105; 16; 19; 5; 3 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
0.1; 1.5; 1.6; 2.0; -0.2; 1.0 | — |
| SECONDARY Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24) |
0.1; 0.1; -2.2; -0.2 | — |
| SECONDARY Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24) |
96; 99; 1; 0; 36; 30 | — |
| SECONDARY Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24) |
1; 0; 132; 129; 1; 2 | — |
| SECONDARY Number of Participants With the Indicated Concomitant Medications |
218; 226; 12; 14; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Man or woman, between the ages of 18 to 65 years, inclusive at screening
- Have a diagnosis of episodic migraine, with or without aura according to InternationalClassification of Headache Disorders (2nd Edition) (ICHD-2) for at least 1 year prior to screening
- Experiences between 2 and 8 migraine attacks per month for the past 12 months
- Women of child bearing potential must be practicing an effective method of birth control
- Women of child-bearing potential must have a negative urine pregnancy test at the screening visit and a negative urine pregnancy test at the randomization visit
- Demonstrate the ability to use the bi-directional delivery device correctly
- Able and willing to read and comprehend written instructions and complete the electronic diary information required by the protocol
- Must be capable, in the opinion of the Investigator, of providing informed consent to participate in the study. Subjects (and their legally acceptable representatives, if applicable) must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria
- Inability to distinguish other headaches from migraine
- Experiences headache of any kind at a frequency greater than or equal to 15 days per month
- History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as subjects who have not responded to an adequate dose and duration of treatment
- Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
- Chronic opioid therapy (>3 consecutive days in the 30 days prior to screening)
- Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks before randomization
- Have hemiplegic or basilar migraine
- History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease, Raynaud syndrome
- Uncontrolled hypertension (screening systolic/diastolic blood pressure >140/95 mmHg)
- Have severe hepatic impairment
- Have history of epilepsy or conditions associated with a lowered seizure threshold
- History (within 2 years) of drug or alcohol abuse as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria
Data sourced from ClinicalTrials.gov (NCT01667679) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.