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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01667679•Avanir Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (13)

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

Key Dates

Start Date

August 1, 2012

Primary Completion Date

March 1, 2014

Completion Date

June 1, 2014

Last Updated

April 12, 2017

Enrollment

275

ACTUAL participants

Conditions

MigraineHeadaches

Interventions

100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

DRUG

OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

MyVitalC: Sleep and Everyday Headache Management

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine