Rapidly Escalating MigrainePhase 2NCT02571049
Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine
A Phase 2 study testing DFN-11 in people with Rapidly Escalating Migraine, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous DFN-11 in subjects with rapidly escalating migraine headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rapidly Escalating Migraine
- What is being tested?
- DFN-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to May 2016
- Phase
- Phase 2
- 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
- Diagnosis of episodic migraine, with or without aura for at least 1 year prior to screening
- Experience an average of 2 to 8 migraines per month for the past 12 months of which approximately 75% or more rapidly escalate to moderate or severe pain within 2 hours of onset
- Females must:
- be practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], or male partner sterilization) before entry and throughout the study, or
- be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
- be postmenopausal (spontaneous amenorrhea for at least 1 year)
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- Females of child-bearing potential must have a negative urine pregnancy test at screening
- Able and willing to read and comprehend written instructions and complete the electronic diary information required by the protocol
- Must have internet access to complete daily headache diary
Who cannot join
- Inability to distinguish migraine from other primary headaches
- Experiences headache of any kind at a frequency greater than or equal to 15 days per month
- Chronic opioid therapy (> 10 days in the 30 days prior to screening)
- Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks before randomization
- Hemiplegic or basilar migraine
- History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
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- Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg in 2 out of 3 readings)
- History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure
- History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria.
- Systemic disease, which in the opinion of the Investigator, would contraindicate participation
- History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation
- Pregnant or lactating women
- Have taken any investigational medication within 30 days before randomization, or are scheduled to receive an investigational drug
- Subjects with a positive urine drug screen for recreational drugs or marijuana (whether legal or not) or for prescription drugs not explained by stated concomitant medications
- Clinical laboratory or electrocardiogram (ECG) abnormality that in the opinion of the Investigator would endanger the subject or interfere with the study conduct. If the results of the clinical laboratory or ECG are outside of normal reference range the subject may still be enrolled but only if these findings are determined to be not clinically significant by the Investigator. This determination must be recorded in the subject's source document prior to enrolment.
- Fridericia's corrected QT (QTcF) interval greater than 450 msec
- Severe renal impairment (creatinine > 2 mg/dl)
- Serum total bilirubin > 2.0 mg/dL
- Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal
- Subjects who in the opinion of the investigator experience rebound headache from caffeine usage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Crossover, Comparator Pilot Study of DFN-11 Injection (Strength A vs. Strength B) for Rapidly Escalating Migraine
Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous DFN-11 in subjects with rapidly escalating migraine headaches.
Read the detailed description
Pilot study to compare the proportion of subjects experiencing pain freedom at 60 minutes post-treatment between headache treated with Strength A of DFN-11 and Strength B of DFN-11
- Conditions
- Rapidly Escalating Migraine
- Being tested
- DFN-11
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFN-11Drug
Also called Sumatriptan succinate injection
Sumatriptan 3 mg versus 6 mg
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan 3 mg then 6 mg | Experimental | DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections Receives: Drug: DFN-11 |
| Sumatriptan 6 mg then 3 mg | Experimental | Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo Receives: Drug: DFN-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment
Measured: 60 minutes post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionMay 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 (1)Papers the sponsor has linked to this study.
- Other trials for Rapidly Escalating 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
- Model description
- DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT02571049
- Sponsor's protocol ID
- DFN-11-CD-006
- Status last verified
- Feb 2018
- First submitted
- 1 Oct 2015
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cady RK, Munjal S, Cady RJ, Manley HR, Brand-Schieber E. Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraine. J Headache Pain. 2017 Dec;18(1):17. doi: 10.1186/s10194-016-0717-7. Epub 2017 Feb 7.
PubMed 28176235
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Crossover, Comparator Pilot Study of DFN-11 Injection (Strength A vs. Strength B) for Rapidly Escalating Migraine
- ClinicalTrials.gov ID
- NCT02571049
- Acronym / sponsor ID
- DFN-11-CD-006
- Conditions
- Rapidly Escalating Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Posted 24 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous DFN-11 in subjects with rapidly escalating migraine headaches.
Detailed description
Pilot study to compare the proportion of subjects experiencing pain freedom at 60 minutes post-treatment between headache treated with Strength A of DFN-11 and Strength B of DFN-11
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan 3 mg then 6 mg | Experimental | Drug: DFN-11DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections |
| Sumatriptan 6 mg then 3 mg | Experimental | Drug: DFN-11Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of episodic migraine, with or without aura for at least 1 year prior to screening
- Experience an average of 2 to 8 migraines per month for the past 12 months of which approximately 75% or more rapidly escalate to moderate or severe pain within 2 hours of onset
- Females must:
- Females of child-bearing potential must have a negative urine pregnancy test at screening
- Able and willing to read and comprehend written instructions and complete the electronic diary information required by the protocol
Key exclusion criteria (20 listed)
- Inability to distinguish migraine from other primary headaches
- Experiences headache of any kind at a frequency greater than or equal to 15 days per month
- Chronic opioid therapy (> 10 days in the 30 days prior to screening)
- Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks before randomization
- Hemiplegic or basilar migraine
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-11Also: Sumatriptan succinate injectionSumatriptan 3 mg versus 6 mg | Drug | Sumatriptan 3 mg then 6 mg, Sumatriptan 6 mg then 3 mg |
Primary outcome
The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment
Time frame: 60 minutes post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28176235Cady RK, Munjal S, Cady RJ, Manley HR, Brand-Schieber E. Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraine. J Headache Pain. 2017 Dec;18(1):17. doi: 10.1186/s10194-016-0717-7. Epub 2017 Feb 7.
- Individual participant dataSharing planned: No
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.
1 site 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-11 in people with Rapidly Escalating Migraine, run by Dr. Reddy's Laboratories Limited at 1 site 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 9 inclusion and 20 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Yes. Results are posted in the registry (first posted 24 Jul 2018). 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?
The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment (time frame: 60 minutes post-treatment). 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 NCT02571049, 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 26 Feb 2019.