MigrainePhase 2NCT02472418
Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches
A Phase 2 study testing DFN-15 Dose A (treatment A) and DFN-15 Dose B (treatment B) in people with Migraine, run by Dr. Reddy's Laboratories Limited at 6 sites in United States.
Trial summary
Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- DFN-15 Dose A (treatment A) and DFN-15 Dose B (treatment B)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 6 sitesUnited States
- Study dates
- 5 Jun 2015to 5 May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 episodic migraine (as defined by International Classification of Headache Disorders [ICHD]-228) who experience an average of 2 to 6 migraine attacks a month for the past 12 months with no more than 14 headache days per month, and with at least 48 hours of headache-free time between migraine attacks;
- Patients with onset of migraine with or without aura before age 50;
- Patients who have migraine with or without aura, in which the aura cannot last longer than 60 minutes;
- Patients who report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale.
Who cannot join
- Patients with medication overuse headache (MOH) as defined by ICHD-228:
- Opioids ≥ 10 days a month during the 90 days prior to screening
- Combination medications (eg, Fiorinal® ≥ 10 days a month)
- Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications > 14 days a month during the 90 days prior to screening
- Triptans or ergots ≥ 10 days a month during the 90 days prior to screening
- Patients on chronic warfarin sodium;
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- Patients taking monoamine oxidase-A (MAO-A) inhibitors;
- Patients on unstable dosages of chronic medications during the 3 months prior to and through screening, or who are not willing or able to maintain a stable pre-study dose throughout study participation;
- Patients with more than 6 migraine attacks a month and/or more than 14 headache days a month (based upon patient self-report);
- Patients with hemiplegic migraine or migraine with brain stem aura or other forms of neurologically complicated migraine;
- Patients with atypical aura;
- Patients with prolonged aura (more than 1 hour).
- Patients with a history of stroke or transient ischemic attack;
- 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 or any other non-migraine headache;
- Patients with a history of more than 10 tension-type headaches per month;
- Patients with a history of cluster headache;
- Patients with a diagnosis of ICHD-2 "probable migraine";
- Patients with uncontrolled hypertension (screening blood pressure ≥ 140/90 mmHg despite appropriate pharmacotherapy);
- Patients with severe renal impairment (defined as serum creatinine > 1.9 mg/dL);
- Patients with serum total bilirubin > 1.9 mg/dL;
- Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 3 times the upper limit of normal;
- Patients with positive serology for human immunodeficiency virus (HIV), Hepatitis B surface antigen, Hepatitis C antibody.
- 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 history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection;
- 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);
- Patients who have participated in a clinical trial involving any medication during the past 30 days or 5 half-lives of the study medication, whichever is longer
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
California Medical Clinic for Headache
Santa Monica, California, 90404
Clinvest/ A Division of Banyan Group, Inc.
Springfield, Missouri, 65807
MedVadis Research Corporation
Watertown, Massachusetts, 02472
About this study
Official title: A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study Evaluating Efficacy of DFN-15 in Patients With Migraine Headache With or Without Aura
Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches.
- Conditions
- Migraine
- Being tested
- DFN-15 Dose A (treatment A), DFN-15 Dose B (treatment B), Placebo (treatment C)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFN-15 Dose A (treatment A)Drug
Also called DFN-15 120 mg
DFN-15 Dose A administered
DFN-15 Dose B (treatment B)Drug
Also called DFN-15 240 mg
DFN-15 Dose B administered
Placebo (treatment C)Other
Also called Placebo (no active ingredient)
Placebo administered
| Study group | Role | What they receive |
|---|---|---|
| DFN-15 120 mg (treatment A) | Experimental | DFN-15 120 mg (treatment A) Receives: Drug: DFN-15 Dose A (treatment A) |
| DFN-15 240 mg (treatment B) | Experimental | DFN-15 240 mg (treatment B) Receives: Drug: DFN-15 Dose B (treatment B) |
| Placebo (treatment C) | Placebo comparator | Placebo (treatment C) Receives: Other: Placebo (treatment C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"
Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start5 Jun 2015
- Primary completion1 Dec 2015
- Study completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 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
- NCT02472418
- Sponsor's protocol ID
- DFN-15-CD-002
- Status last verified
- Apr 2018
- First submitted
- 8 Jun 2015
- Last updated
- 22 May 2018
- Results posted
- No
Publications
Munjal S, Bennett A. Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study. Neuropsychiatr Dis Treat. 2017 Nov 7;13:2797-2802. doi: 10.2147/NDT.S151834. eCollection 2017.
PubMed 29158678
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study Evaluating Efficacy of DFN-15 in Patients With Migraine Headache With or Without Aura
- ClinicalTrials.gov ID
- NCT02472418
- Acronym / sponsor ID
- DFN-15-CD-002
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2015 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DFN-15 120 mg (treatment A) | Experimental | Drug: DFN-15 Dose A (treatment A)DFN-15 120 mg (treatment A) |
| DFN-15 240 mg (treatment B) | Experimental | Drug: DFN-15 Dose B (treatment B)DFN-15 240 mg (treatment B) |
| Placebo (treatment C) | Placebo comparator | Other: Placebo (treatment C)Placebo (treatment C) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a history of episodic migraine (as defined by International Classification of Headache Disorders [ICHD]-228) who experience an average of 2 to 6 migraine attacks a month for the past 12 months with no more than 14 headache days per month, and with at least 48 hours of headache-free time between migraine attacks;
- Patients with onset of migraine with or without aura before age 50;
- Patients who have migraine with or without aura, in which the aura cannot last longer than 60 minutes;
- Patients who report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale.
Key exclusion criteria (27 listed)
- Patients with medication overuse headache (MOH) as defined by ICHD-228:
- Patients on chronic warfarin sodium;
- Patients taking monoamine oxidase-A (MAO-A) inhibitors;
- Patients on unstable dosages of chronic medications during the 3 months prior to and through screening, or who are not willing or able to maintain a stable pre-study dose throughout study participation;
- Patients with more than 6 migraine attacks a month and/or more than 14 headache days a month (based upon patient self-report);
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-15 Dose A (treatment A)Also: DFN-15 120 mgDFN-15 Dose A administered | Drug | DFN-15 120 mg (treatment A) |
| DFN-15 Dose B (treatment B)Also: DFN-15 240 mgDFN-15 Dose B administered | Drug | DFN-15 240 mg (treatment B) |
| Placebo (treatment C)Also: Placebo (no active ingredient)Placebo administered | Other | Placebo (treatment C) |
Primary outcome
Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"
Time frame: 2 hour
Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Results publication: PubMed 29158678Munjal S, Bennett A. Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study. Neuropsychiatr Dis Treat. 2017 Nov 7;13:2797-2802. doi: 10.2147/NDT.S151834. eCollection 2017.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFN-15 Dose A (treatment A) and DFN-15 Dose B (treatment B) in people with Migraine, run by Dr. Reddy's Laboratories Limited at 6 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 4 inclusion and 27 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Free, defined as a score of "0" on a numerical scale of "0" to "3" (time frame: 2 hour). 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 NCT02472418, which also lists 1 linked publication.
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 22 May 2018.