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

NCT ID: NCT01667679

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-06-30

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

Conditions

Migraine; Headaches

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OPTINOSE SUMATRIPTAN and Placebo

20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet

Group Type: EXPERIMENTAL

OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet

Intervention Type: DRUG

100mg Sumatriptan and OPTINOSE Placebo

100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

Group Type: ACTIVE_COMPARATOR

100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

Intervention Type: DRUG

Interventions

100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

Intervention Type: DRUG

OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avanir Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

San Francisco Clinical Research Center

San Francisco, California, United States

California Medical Clinic for Headache

Santa Monica, California, United States

Associated Neurologists of Southern CT, P.C.

Fairfied, Connecticut, United States

Premiere Research Institute

West Palm Beach, Florida, United States

MedVadis

Watertown, Massachusetts, United States

Michigan Head and Pain Institute

Ann Arbor, Michigan, United States

ClinVest

Springfield, Missouri, United States

Mercy Health Research

St Louis, Missouri, United States

DENT Neurologic Institute

Amherst, New York, United States

Headache Welness Center

Greensboro, North Carolina, United States

PMG Research of Winston Salem, LLC

Winston-Salem, North Carolina, United States

Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28880380 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25941016 (View on PubMed)

Other Identifiers

OPN-SUM-MIG-3302

Identifier Type: -

Identifier Source: org_study_id