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

NCT01667679 | Completed Phase 3 Results

• 1 other identifier: OPN-SUM-MIG-3302
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 13

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.

Conditions

Migraine; Headaches

Keywords

Migraine; Headaches; Sumatriptan

Outcome Measures

Primary Outcomes (1)

• Mean Sum of Migraine Pain Intensity Differences (SPID)-30

  SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.

  Baseline and 30 minutes post-dose (up to 24 weeks)

Secondary Outcomes (26)

• Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe

  Baseline and 30 minutes post-dose (up to 24 weeks)

• Percentage of Attacks in Which Pain Reduction Was Achieved

  10, 15, 30, 45, 60, 90, and 120 minutes

• Percentage of Attacks in Which Pain Freedom Was Achieved

  Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)

• Percentage of Attacks in Which Pain Relief Was Achieved

  Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)

• Median Time to Pain Freedom

  120 minutes post-dose (up to 24 weeks)

Study Arms (2)

OPTINOSE SUMATRIPTAN and Placebo

EXPERIMENTAL

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

Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet

100mg Sumatriptan and OPTINOSE Placebo

ACTIVE COMPARATOR

100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

Interventions

100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally DRUG

100mg Sumatriptan and OPTINOSE Placebo

OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet DRUG

OPTINOSE SUMATRIPTAN and Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avanir Pharmaceuticals: lead

Study Sites (13)

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Associated Neurologists of Southern CT, P.C.

Fairfied, Connecticut, 06824, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

MedVadis

Watertown, Massachusetts, 02472, United States

Location

Michigan Head and Pain Institute

Ann Arbor, Michigan, 48104-5199, United States

Location

ClinVest

Springfield, Missouri, 65807, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

DENT Neurologic Institute

Amherst, New York, 14226, United States

Location

Headache Welness Center

Greensboro, North Carolina, 27405, United States

Location

PMG Research of Winston Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Related Publications (2)

• 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.

  PMID: 28880380 DERIVED

• 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.

  PMID: 25941016 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Nadine Knowles; Executive Director, Research & Development Operations
• Organization: Avanir Pharmaceuticals

nknowles@avanir.com

1-949-268-8972

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 17, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 12, 2017
• Results First Posted: March 14, 2017

Record last verified: 2017-03

Locations

US (13)