MigrainePhase 4NCT00443352
A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache
A Phase 4 study testing duloxetine in people with Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2012
- Phase
- Phase 4
- 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
- Subject is male or female between the ages of 18 and 65, inclusive
- Subject has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
- Subject has experienced between 4 and 10 migraine headaches per month (inclusive) over the past six months, with at least 24 hours separating attacks
- Subject has less than 15 total headache days per month
- Subject is able to differentiate migraine attacks from other headache types, if applicable
- Subjects daily medications (for any indication) have remained at a stable dose for the 60 days preceding screening
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- Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator and mutually agreed upon with patient), if female of child-bearing potential
- Subjects currently taking a single agent for the prevention of migraine must be on a stable dose (unchanged for 2 months) prior to study entry
- Subject has negative urine pregnancy test prior to study entry, if female of child-bearing potential
- Subject is able to understand and comply with all study requirements
- Subject provides written informed consent prior to any screening procedures being conducted
Who cannot join
- Subjects with onset of migraine after 50 years of age
- Subjects who have been previously treated or are currently being treated with duloxetine
- Subjects who have failed greater than 3 adequate trials of other medications the prevention of migraine, as determined by investigator
- Subjects who have a known hypersensitivity to duloxetine or any of the inactive ingredients
- Subject has taken any medication which has been shown to be effective for migraine prophylaxis, on a daily basis within the 4 weeks prior to screening or at any time during participation in the study, for any indication.
- Subjects with a history of significant drug or alcohol abuse within the past year
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- Subjects with major depressive disorder or who have had a suicidal ideation in the 3 months prior to screening or have a history of attempted suicide
- Subjects who have a Beck Depression Inventory score of > 18 at screening
- Subjects who have > 0 on question number 9 of Beck Depression Inventory (Suicidal Thoughts or Wishes question)
- Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
- Subjects with a current or history of a hepatic or renal disorder
- Subjects with uncontrolled narrow angle glaucoma
- Subjects who have experienced significant side effects from two different SSRI and/or SNRI therapies, as determined by investigator
- Subjects with uncontrolled restless legs syndrome, as determined by investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.
Read the detailed description
Pharmacologic therapy of migraine headaches can be divided into two types: acute treatment and prophylactic treatment. Acute headache medication is intended to relieve the pain and disability of an acute attack and stop its progression. Prophylactic (preventive) headache therapy is generally given daily, even in the absence of headache, to reduce the frequency and perhaps the severity of anticipated attacks. Subjects who experience recurring migraine attacks which significantly interfere with the subject's daily routine despite acute treatment, may warrant chronic prophylactic treatment.
Duloxetine may be an important treatment option for millions of unsuccessfully treated migraine patients and therefore warrants further study. Considering this, we propose a single-center, open-label pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects with episodic migraine headaches. The results of this pilot trial will provide preliminary insight into the clinical role duloxetine may play in the treatment of headache, as well as provide a basis for future well-controlled trials of this medication.
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.
- Conditions
- Migraine
- Being tested
- duloxetine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called Cymbalta
Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Duloxetine 120mg daily for 12 weeks. Receives: Drug: duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.
Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).
Measured: Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2012
- Study completionNov 2012
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 MigraineStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William B. Young, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443352
- Sponsor's protocol ID
- Protocol #: F1J-MC-I
- Status last verified
- Apr 2014
- First submitted
- 5 Mar 2007
- Last updated
- 26 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine
- ClinicalTrials.gov ID
- NCT00443352
- Acronym / sponsor ID
- Protocol #: F1J-MC-I
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.
Detailed description
Pharmacologic therapy of migraine headaches can be divided into two types: acute treatment and prophylactic treatment. Acute headache medication is intended to relieve the pain and disability of an acute attack and stop its progression. Prophylactic (preventive) headache therapy is generally given daily, even in the absence of headache, to reduce the frequency and perhaps the severity of anticipated attacks. Subjects who experience recurring migraine attacks which significantly interfere with the subject's daily routine despite acute treatment, may warrant chronic prophylactic treatment.
Duloxetine may be an important treatment option for millions of unsuccessfully treated migraine patients and therefore warrants further study. Considering this, we propose a single-center, open-label pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects with episodic migraine headaches. The results of this pilot trial will provide preliminary insight into the clinical role duloxetine may play in the treatment of headache, as well as provide a basis for future well-controlled trials of this medication.
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: duloxetineDuloxetine 120mg daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is male or female between the ages of 18 and 65, inclusive
- Subject has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
- Subject has experienced between 4 and 10 migraine headaches per month (inclusive) over the past six months, with at least 24 hours separating attacks
- Subject has less than 15 total headache days per month
- Subject is able to differentiate migraine attacks from other headache types, if applicable
Key exclusion criteria (14 listed)
- Subjects with onset of migraine after 50 years of age
- Subjects who have been previously treated or are currently being treated with duloxetine
- Subjects who have failed greater than 3 adequate trials of other medications the prevention of migraine, as determined by investigator
- Subjects who have a known hypersensitivity to duloxetine or any of the inactive ingredients
- Subject has taken any medication which has been shown to be effective for migraine prophylaxis, on a daily basis within the 4 weeks prior to screening or at any time during participation in the study, for any indication.
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 |
|---|---|---|
| duloxetineAlso: CymbaltaDuloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day) | Drug | Duloxetine |
Primary outcome
Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.
Time frame: Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).
Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- 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.
William B. Young, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing duloxetine in people with Migraine, run by Thomas Jefferson University 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 11 inclusion and 14 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 May 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 26 May 2014). 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?
Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period. (time frame: Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).). 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 26 May 2014.