Clinical trial NCT01667679: 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
Official title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Cross-Over Study Evaluating the 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Headaches
Keywords: Migraine
Headaches
Sumatriptan
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objective for this study is to compare the proportion of attacks in which pain reduction (defined as a decrease in pain intensity of at least 1 point) is achieved at 30 minutes following 20 mg OPTINOSE SUMATRIPTAN treatment with 100 mg Sumatriptan Tablets

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

Primary outcomes:
measure: Mean Sum of Migraine Pain Intensity Differences (SPID)-30
timeFrame: Baseline and 30 minutes post-dose (up to 24 weeks)
Secondary outcomes:
measure: Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe
timeFrame: Baseline and 30 minutes post-dose (up to 24 weeks)
measure: Percentage of Attacks in Which Pain Reduction Was Achieved
timeFrame: 10, 15, 30, 45, 60, 90, and 120 minutes
measure: Percentage of Attacks in Which Pain Freedom Was Achieved
timeFrame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
measure: Percentage of Attacks in Which Pain Relief Was Achieved
timeFrame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
measure: Median Time to Pain Freedom
timeFrame: 120 minutes post-dose (up to 24 weeks)
measure: Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
timeFrame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
measure: Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
timeFrame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
measure: Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event
timeFrame: Baseline compared to Vist 2, 3 and 4
measure: Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: 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)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: 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)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: 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)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: 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)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: 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)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: 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)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
timeFrame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
measure: Number of Participants With the Indicated Concomitant Medications
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Fairfied
country: United States
facility: Associated Neurologists of Southern CT, P.C.
state: Connecticut
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Watertown
country: United States
facility: MedVadis
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head and Pain Institute
state: Michigan
city: Springfield
country: United States
facility: ClinVest
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Amherst
country: United States
facility: DENT Neurologic Institute
state: New York
city: Greensboro
country: United States
facility: Headache Welness Center
state: North Carolina
city: Winston Salem
country: United States
facility: PMG Research of Winston Salem, LLC
state: North Carolina
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
Study officials:
References:
citation: Lipton RB, McGinley JS, Shulman KJ, Wirth RJ, Buse DC. 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. Headache. 2017 Nov;57(10):1570-1582. doi: 10.1111/head.13165. Epub 2017 Sep 7.
citation: Tepper SJ, Cady RK, Silberstein S, Messina J, Mahmoud RA, Djupesland PG, Shin P, Siffert J. 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. Headache. 2015 May;55(5):621-35. doi: 10.1111/head.12583. Epub 2015 May 4.