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 (COMPASS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optinose US Inc.
ClinicalTrials.gov Identifier:
NCT01667679
First received: August 6, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Migraine
Headaches
Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Cross-Over Study A Phase III Study Evaluating the Efficacy and Safety of 20 mg SuMatriptan Powder Delivered IntrAnasally With the Bi-directional Device Compared With 100 mg Sumatriptan TabletsS in Adults With Acute Migraine With or Without Aura

Resource links provided by NLM:


Further study details as provided by Optinose US Inc.:

Primary Outcome Measures:
  • Mean SPID-30 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The primary endpoint is the mean SPID-30, defined as the mean area under the curve of the pain intensity differences from dosing to through 30 minutes for headaches with a baseline intensity of mild, moderate, or severe.


Secondary Outcome Measures:
  • SPID-30 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    SPID-30 for attacks treated when pain was mild, and attacks treated when pain was moderate/severe

  • Pain reduction [ Time Frame: 10, 15, 30, 45, 60, 90, and 120 minutes ] [ Designated as safety issue: No ]
    Percent of attacks in which pain reduction (defined as a decrease in pain intensity of at least 1 point) is achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose.

  • Pain freedom [ Time Frame: 10, 15, 30, 45, 60, 90, and 120 minutes ] [ Designated as safety issue: No ]
    Percent of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) is achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks, attacks treated when pain was mild, and attacks treated when pain was moderate/severe.

  • Pain relief [ Time Frame: 10, 15, 30, 45, 60, 90 and 120 minutes ] [ Designated as safety issue: No ]
    Percent of attacks treated at a severity of moderate or severe that achieve pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose

  • Medain time to pain freedom [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Median time to pain freedom within 120 minutes of the initial dose

  • Change in headache severity [ Time Frame: baseline, 10, 15, 30, 45, 60, 90, and 120 minutes ] [ Designated as safety issue: No ]
    Headache severity changes from baseline at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose

  • Change in clinical disability score [ Time Frame: baseline, 10, 15, 30, 45, 60, 90, and 120 minutes ] [ Designated as safety issue: No ]
    Clinical disability changes from baseline at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose, as measured by the Clinical Disability Scale

  • Change in safety profile [ Time Frame: Baseline compared to Vist 2, 3 and 4 ] [ Designated as safety issue: Yes ]
    To provide a descriptive safety profile including summaries of adverse events (AEs).

  • change in safety profile [ Time Frame: Baseline compared to Vist 2, 3 and 4 ] [ Designated as safety issue: Yes ]
    To provide a descriptive safety profile including summaries of clinical laboratory assessments.

  • Change in safety profile [ Time Frame: Baseline compared to Vist 2, 3 and 4 ] [ Designated as safety issue: Yes ]
    To provide a descriptive safety profile including summaries of vital signs measurements.

  • Change in safety profile [ Time Frame: Baseline compared to Vist 2, 3 and 4 ] [ Designated as safety issue: Yes ]
    To provide a descriptive safety profile including summaries of electrocardiogram (ECG) parameters

  • Change in safety profile [ Time Frame: Baseline compared to Vist 2, 3 and 4 ] [ Designated as safety issue: Yes ]
    To provide a descriptive safety profile including summaries of physical examinations.

  • Change in safety profile [ Time Frame: Baseline compared to Vist 2, 3 and 4 ] [ Designated as safety issue: Yes ]
    To provide a descriptive safety profile including summaries of concomitant medication usage.


Enrollment: 275
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPTINOSE SUMATRIPTAN and Placebo
20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet
Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
Active Comparator: 100mg Sumatriptan and OPTINOSE Placebo
100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667679

Locations
United States, California
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
United States, Connecticut
Associated Neurologists of Southern CT, P.C.
Fairfied, Connecticut, United States, 06824
United States, Florida
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
MedVadis
Watertown, Massachusetts, United States, 02472
United States, Michigan
Michigan Head and Pain Institute
Ann Arbor, Michigan, United States, 48104-5199
United States, Missouri
ClinVest
Springfield, Missouri, United States, 65807
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, New York
DENT Neurologic Institute
Amherst, New York, United States, 14226
United States, North Carolina
Headache Welness Center
Greensboro, North Carolina, United States, 27405
PMG Research of Winston Salem, LLC
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Optinose US Inc.
  More Information

No publications provided

Responsible Party: Optinose US Inc.
ClinicalTrials.gov Identifier: NCT01667679     History of Changes
Other Study ID Numbers: OPN-SUM-MIG-3302
Study First Received: August 6, 2012
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Optinose US Inc.:
Migraine
Headaches
Sumatriptan

Additional relevant MeSH terms:
Headache
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Sumatriptan
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 29, 2014