Acute MigrainePhase 3NCT02279082
DFN-02 Open Label Safety Study in Patients With Acute Migraine
A Phase 3 study testing DFN-02 in people with Acute Migraine, run by Dr. Reddy's Laboratories Limited at 24 sites in United States.
Trial summary
A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Migraine
- What is being tested?
- DFN-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 24 sitesUnited States
- Study dates
- Sep 2014to Mar 2016
- 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
- Patients with a history of acute migraine (using International Classification of Headache Disorders [ICHD] criteria, second edition);
- Patients who, in the opinion of the investigator, are willing and able to:
- Return to the study site within 72 hours of the first use of study medication,
- Record each migraine and each instance of the use of study medication and rescue medication in a patient diary for the duration of the study;
- Patients who can use the nasal spray device correctly after instruction.
Who cannot join
- Patients on onabotulinumtoxinA (Botox®) or other botulinum toxin treatment; or history of receiving such treatment 180 days prior to screening;
- Patients with a history of stroke or transient ischemic attack (TIA);
- Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;
- Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache;
- Patients with ischemic coronary artery disease (CAD; ie, angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetal's angina);
- Patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders;
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- Patients with uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg);
- Patients with peripheral vascular disease or ischemic bowel disease;
- Patients taking any medications or with illnesses likely to affect the physiology of the nasal mucosa (ie, patients with nasal septum surgery, chronic sinusitis, or chronic nasal rhinitis). (Note: Patients who have acute conditions such as acute sinusitis may be rescreened 14 days after resolution of acute sinusitis.);
- Patients with any abnormal nasal physiology or pathology which, in the opinion of the investigator, would not allow the objectives of the study to be accomplished;
- Patients with known intolerance to nasal sprays;
- Patients with severe renal impairment (defined as serum creatinine > 2 mg/dL);
- Patients with serum total bilirubin > 2.0 mg/dL;
- Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal (ULN);
- Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection;
- Patients with a positive urine drug screen for illicit drugs or for prescription drugs not explained by stated concomitant medications. (Positive drug screen for marijuana is exclusionary.):
- Patients consuming opioids for the treatment of migraine or using opioids or barbiturates temporarily for a legitimate medical cause may participate as long as they do not meet the MOH criteria.
- Benzodiazepines are allowed if used for legitimate medical use.
- Chronic use of amphetamines to treat attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) and related disorders is allowed as long as the regimen has been stable for at least 3 months prior to screening and is expected to remain stable throughout the study.
- Note: For the above-mentioned conditions, the site must obtain medical monitor approval.
- Patients with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection;
- Patients who have received treatment with an investigational drug or device within 4 weeks of the screening visit or participated in a central nervous system clinical trial in the 3 months prior to screening;
- Patients who test positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody serology testing.
- Patients with any other medical condition that, in the judgment of the investigator or medical monitor, would confound the objectives of the study (eg, cancer history [except basal cell carcinoma], systemic lupus erythematosus)
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Dent Neurologic Institute
Amherst, New York, 14226
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
FutureSearch Trials of Neurology, LP
Austin, Texas, 78731
Protenium Clinical Research, LLC
Bedford, Texas, 76022
Florida Clinical Research Center
Bradenton, Florida, 34201
Community Research
Cincinnati, Ohio, 45255
Future Search Trials of Dallas, LP
Dallas, Texas, 75231
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, 06824
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
Novex Clinical Research
New Bedford, Massachusetts, 02740
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Arizona Research Center
Phoenix, Arizona, 85023
Northern California Clinical Research Center
Redding, California, 96001
Breakthrough Clinical Trials
San Bernardino, California, 92408
San Francisco Clinical Research Center
San Francisco, California, 94109
California Medical Clinic for Headache
Santa Monica, California, 90404
Carman Research
Smyrna, Georgia, 30080
Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri, 65807
Stanford University Medical Center
Stanford, California, 94305
Neurology Clinical Research, Inc
Sunrise, Florida, 33351
MedVadis Research Corporation
Watertown, Massachusetts, 02472
Upstate Clinical Research Associates LLC
Williamsville, New York, 14221
About this study
A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines
- Conditions
- Acute Migraine
- Being tested
- DFN-02
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFN-02Drug
Active Experimental Drug
| Study group | Role | What they receive |
|---|---|---|
| DFN-02 | Experimental | DFN-02 to be taken during migraine attack Receives: Drug: DFN-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionMar 2016
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 Acute 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279082
- Sponsor's protocol ID
- DFN-02-CD-010
- Status last verified
- Feb 2018
- First submitted
- 23 Oct 2014
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Munjal S, Gautam A, Offman E, Brand-Schieber E, Allenby K, Fisher DM. A Randomized Trial Comparing the Pharmacokinetics, Safety, and Tolerability of DFN-02, an Intranasal Sumatriptan Spray Containing a Permeation Enhancer, With Intranasal and Subcutaneous Sumatriptan in Healthy Adults. Headache. 2016 Oct;56(9):1455-1465. doi: 10.1111/head.12905. Epub 2016 Sep 10.
PubMed 27613076Munjal S, Brand-Schieber E, Allenby K, Spierings ELH, Cady RK, Rapoport AM. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine. J Headache Pain. 2017 Dec;18(1):31. doi: 10.1186/s10194-017-0740-3. Epub 2017 Mar 1.
PubMed 28251391
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DFN-02 Open Label Safety Study in Patients With Acute Migraine
- ClinicalTrials.gov ID
- NCT02279082
- Acronym / sponsor ID
- DFN-02-CD-010
- Conditions
- Acute Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Posted 28 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFN-02 | Experimental | Drug: DFN-02DFN-02 to be taken during migraine attack |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a history of acute migraine (using International Classification of Headache Disorders [ICHD] criteria, second edition);
- Patients who, in the opinion of the investigator, are willing and able to:
- Patients who can use the nasal spray device correctly after instruction.
Key exclusion criteria (24 listed)
- Patients on onabotulinumtoxinA (Botox®) or other botulinum toxin treatment; or history of receiving such treatment 180 days prior to screening;
- Patients with a history of stroke or transient ischemic attack (TIA);
- Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;
- Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache;
- Patients with ischemic coronary artery disease (CAD; ie, angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetal's angina);
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 |
|---|---|---|
| DFN-02Active Experimental Drug | Drug | DFN-02 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27613076Munjal S, Gautam A, Offman E, Brand-Schieber E, Allenby K, Fisher DM. A Randomized Trial Comparing the Pharmacokinetics, Safety, and Tolerability of DFN-02, an Intranasal Sumatriptan Spray Containing a Permeation Enhancer, With Intranasal and Subcutaneous Sumatriptan in Healthy Adults. Headache. 2016 Oct;56(9):1455-1465. doi: 10.1111/head.12905. Epub 2016 Sep 10.
- Results publication: PubMed 28251391Munjal S, Brand-Schieber E, Allenby K, Spierings ELH, Cady RK, Rapoport AM. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine. J Headache Pain. 2017 Dec;18(1):31. doi: 10.1186/s10194-017-0740-3. Epub 2017 Mar 1.
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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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DFN-02 in people with Acute Migraine, run by Dr. Reddy's Laboratories Limited at 24 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 5 inclusion and 24 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 28 Aug 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?
Number of Participants With Treatment Emergent Adverse Events (time frame: 6 months). 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 NCT02279082, 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 9 Mar 2018.