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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Optinose US Inc.
ClinicalTrials.gov Identifier:
NCT01667679
First received: August 6, 2012
Last updated: September 25, 2013
Last verified: December 2012

August 6, 2012
September 25, 2013
August 2012
March 2014   (final data collection date for primary outcome measure)
Pain reduction [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01667679 on ClinicalTrials.gov Archive Site
  • Complete Pain Relief [ Time Frame: 10, 15, 30, 45, 60, 90 and 120 minutes ] [ Designated as safety issue: No ]
    Complete relief pain relief, defined as pain level reduced to none [Grade 0]) at 10, 15, 30, 45,60, 90, and 120 minutes after 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.
Same as current
Not Provided
Not Provided
 
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
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Migraine
  • Headaches
  • Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
  • Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
  • Experimental: OPTINOSE SUMATRIPTAN and Placebo
    20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet
    Intervention: Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
  • Active Comparator: 100mg Sumatriptan and OPTINOSE Placebo
    100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
    Intervention: Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01667679
OPN-SUM-MIG-3302
No
Optinose US Inc.
Optinose US Inc.
Not Provided
Not Provided
Optinose US Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP