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

Migraine Clinical Trial

— COMPASS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667679
• Other study ID #: OPN-SUM-MIG-3302
• Status: Completed
• Phase: Phase 3
• First received: August 6, 2012
• Last updated: October 20, 2014
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Optinose US Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headaches
• Migraine
• Migraine Disorders

Intervention

Drug:
• 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

• OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet

Locations

Country	Name	City	State
United States	DENT Neurologic Institute	Amherst	New York
United States	Michigan Head and Pain Institute	Ann Arbor	Michigan
United States	Associated Neurologists of Southern CT, P.C.	Fairfied	Connecticut
United States	Headache Welness Center	Greensboro	North Carolina
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Jefferson Headache Center	Philadelphia	Pennsylvania
United States	San Francisco Clinical Research Center	San Francisco	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	ClinVest	Springfield	Missouri
United States	Mercy Health Research	St. Louis	Missouri
United States	MedVadis	Watertown	Massachusetts
United States	Premiere Research Institute	West Palm Beach	Florida
United States	PMG Research of Winston Salem, LLC	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Optinose US Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean SPID-30	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.	30 minutes	No
Secondary	SPID-30	SPID-30 for attacks treated when pain was mild, and attacks treated when pain was moderate/severe	30 minutes	No
Secondary	Pain reduction	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.	10, 15, 30, 45, 60, 90, and 120 minutes	No
Secondary	Pain freedom	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.	10, 15, 30, 45, 60, 90, and 120 minutes	No
Secondary	Pain relief	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	10, 15, 30, 45, 60, 90 and 120 minutes	No
Secondary	Medain time to pain freedom	Median time to pain freedom within 120 minutes of the initial dose	120 minutes	No
Secondary	Change in headache severity	Headache severity changes from baseline at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose	baseline, 10, 15, 30, 45, 60, 90, and 120 minutes	No
Secondary	Change in clinical disability score	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	baseline, 10, 15, 30, 45, 60, 90, and 120 minutes	No
Secondary	Change in safety profile	To provide a descriptive safety profile including summaries of adverse events (AEs).	Baseline compared to Vist 2, 3 and 4	Yes
Secondary	change in safety profile	To provide a descriptive safety profile including summaries of clinical laboratory assessments.	Baseline compared to Vist 2, 3 and 4	Yes
Secondary	Change in safety profile	To provide a descriptive safety profile including summaries of vital signs measurements.	Baseline compared to Vist 2, 3 and 4	Yes
Secondary	Change in safety profile	To provide a descriptive safety profile including summaries of electrocardiogram (ECG) parameters	Baseline compared to Vist 2, 3 and 4	Yes
Secondary	Change in safety profile	To provide a descriptive safety profile including summaries of physical examinations.	Baseline compared to Vist 2, 3 and 4	Yes
Secondary	Change in safety profile	To provide a descriptive safety profile including summaries of concomitant medication usage.	Baseline compared to Vist 2, 3 and 4	Yes