Medication Overuse HeadachePhase 2NCT02583425
Pilot Study of DFN-11 Injection in Medication Overuse Headache
A Phase 2 study testing DFN-11 Injection in people with Medication Overuse Headache, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Medication Overuse Headache
- What is being tested?
- DFN-11 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Nov 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 medication overuse headache within the past year in the following categories
- Diagnosis of migraine, with or without aura for at least 12 months
- Experience an average of > 10 headache days per month for the past 12 months
- 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 willing to continue throughout the study, or ii. be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or iii. be postmenopausal (spontaneous amenorrhea for at least 1 year)
- Females of child-bearing potential must have a negative urine pregnancy test at all visits.
- Able and willing to read and comprehend written instructions and complete the electronic diary.
- Must have internet access to complete daily headache diary.
Who cannot join
- Current use of medication for headache/migraine prophylaxis that has not been stable for 30 days prior to screening. Stable is defined as no recent dosing change within 30 days of screening.
- Hemiplegic or basilar migraine
- History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
- Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg in 2 out of 3 readings)
- Clinically significant hepatic impairment
- History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure
Show all 19Show fewer
- 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 screening, 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 with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) > 7.0%, or with diabetes mellitus requiring insulin
- 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
Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache
- Conditions
- Medication Overuse Headache
- Being tested
- DFN-11 Injection
- Medical subject headings
- Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFN-11 InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| DFN-11 | Experimental | DFN-11 Injection upon occurrence of migraine Receives: Drug: DFN-11 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)
Measured: 28 days Baseline period and 28 days of Treatment period (Total 56 days)
Secondary outcomes (1)
The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)
Measured: 28 days Baseline period and 28 days of Treatment period (Total 56 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionNov 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.
- Other trials for Medication Overuse HeadacheStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT02583425
- Sponsor's protocol ID
- DFN-11-CD-007
- Status last verified
- Feb 2018
- First submitted
- 1 Oct 2015
- Last updated
- 3 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of DFN-11 Injection in Medication Overuse Headache
- ClinicalTrials.gov ID
- NCT02583425
- Acronym / sponsor ID
- DFN-11-CD-007
- Conditions
- Medication Overuse Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Posted 3 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFN-11 | Experimental | Drug: DFN-11 InjectionDFN-11 Injection upon occurrence of migraine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of medication overuse headache within the past year in the following categories
- Diagnosis of migraine, with or without aura for at least 12 months
- Experience an average of > 10 headache days per month for the past 12 months
- Females must:
- Females of child-bearing potential must have a negative urine pregnancy test at all visits.
Key exclusion criteria (19 listed)
- Current use of medication for headache/migraine prophylaxis that has not been stable for 30 days prior to screening. Stable is defined as no recent dosing change within 30 days of screening.
- Hemiplegic or basilar migraine
- History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
- Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg in 2 out of 3 readings)
- Clinically significant hepatic impairment
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-11 Injection | Drug | DFN-11 |
Primary outcome
The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)
Time frame: 28 days Baseline period and 28 days of Treatment period (Total 56 days)
1 secondary outcome
The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)
Time frame: 28 days Baseline period and 28 days of Treatment period (Total 56 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 Injection in people with Medication Overuse Headache, 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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 3 Apr 2018. 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 3 Apr 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 Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) (time frame: 28 days Baseline period and 28 days of Treatment period (Total 56 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2018.