MigrainePhase 3COMPASSNCT01667679
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 Phase 3 study of Migraine and Headaches, run by Avanir Pharmaceuticals at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2012to Jun 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
DENT Neurologic Institute
Amherst, New York, 14226
Michigan Head and Pain Institute
Ann Arbor, Michigan, 48104-5199
Associated Neurologists of Southern CT, P.C.
Fairfied, Connecticut, 06824
Headache Welness Center
Greensboro, North Carolina, 27405
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
San Francisco Clinical Research Center
San Francisco, California, 94109
California Medical Clinic for Headache
Santa Monica, California, 90404
ClinVest
Springfield, Missouri, 65807
Mercy Health Research
St Louis, Missouri, 63141
MedVadis
Watertown, Massachusetts, 02472
Premiere Research Institute
West Palm Beach, Florida, 33407
PMG Research of Winston Salem, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
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.
Read the 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
- Being tested
- 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally, OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
- Keywords
- Migraine, Headaches, Sumatriptan
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasallyDrug
OPTINOSE SUMATRIPTAN delivered nasally and placebo tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| OPTINOSE SUMATRIPTAN and Placebo | Experimental | 20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet Receives: Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet |
| 100mg Sumatriptan and OPTINOSE Placebo | Active comparator | 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally Receives: Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 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 ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.
Measured: Baseline and 30 minutes post-dose (up to 24 weeks)
Percentage of Attacks in Which Pain Reduction Was Achieved
Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Measured: 10, 15, 30, 45, 60, 90, and 120 minutes
Percentage of Attacks in Which Pain Freedom Was Achieved
Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Measured: 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
Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Measured: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Median Time to Pain Freedom
Pain freedom is defined as a pain level reduced to none (Grade 0).
Measured: 120 minutes post-dose (up to 24 weeks)
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event
An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.
Measured: Baseline compared to Vist 2, 3 and 4
Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with "1+," "2+," and "3+" indicating increasing amounts of metabolites in urine.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of "normal" or "abnormal" was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.
Measured: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Number of Participants With the Indicated Concomitant Medications
Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667679
- Sponsor's protocol ID
- OPN-SUM-MIG-3302
- Acronym
- COMPASS
- Status last verified
- Mar 2017
- First submitted
- 6 Aug 2012
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28880380Tepper 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.
PubMed 25941016
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01667679
- Acronym / sponsor ID
- COMPASS / OPN-SUM-MIG-3302
- Keywords
- Migraine, Headaches, Sumatriptan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Avanir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Posted 14 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTINOSE SUMATRIPTAN and Placebo | Experimental | Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet |
| 100mg Sumatriptan and OPTINOSE Placebo | Active comparator | Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Mean Sum of Migraine Pain Intensity Differences (SPID)-30
Time frame: Baseline and 30 minutes post-dose (up to 24 weeks)
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.
26 secondary outcomes
Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe
Time frame: Baseline and 30 minutes post-dose (up to 24 weeks)
Percentage of Attacks in Which Pain Reduction Was Achieved
Time frame: 10, 15, 30, 45, 60, 90, and 120 minutes
Percentage of Attacks in Which Pain Freedom Was Achieved
Time frame: 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
Time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Median Time to Pain Freedom
Time frame: 120 minutes post-dose (up to 24 weeks)
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
Time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
Time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event
Time frame: Baseline compared to Vist 2, 3 and 4
Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Number of Participants With the Indicated Concomitant Medications
Time frame: up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28880380Lipton 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.
- Derived from this study: PubMed 25941016Tepper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Migraine and Headaches, run by Avanir Pharmaceuticals at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Sum of Migraine Pain Intensity Differences (SPID)-30 (time frame: Baseline and 30 minutes post-dose (up to 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01667679, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.