Migraine With AuraPhase 4NCT01319825
Preventive Treatment of Episodic and Chronic Migraine
A Phase 4 study testing milnacipran in people with Migraine With Aura and Migraine Without Aura, run by California Medical Clinic for Headache at 1 site in United States.
Trial summary
This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura, Chronic Migraine
- What is being tested?
- milnacipran
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2012
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine with or without aura or chronic migraine.
- Subject age 18 to 70.
- At least 2 migraine attacks per month.
- Willing ang able to give written informed consent.
- Willing and able to complete the entire course of the study and to comply with study instructions.
- Willing to taper and discontinue their current preventive medications.
Who cannot join
- Subject is pregnant, lactating or planning a pregnancy in the next year.
- Subject is female of child-bearing potential and not taking adequate forms of birth control.
- Significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.
- Previous failure of four or more adequate trials of preventive medication.
- Currently on any form of antidepressant for depression and not able to discontinue.
- Currently demonstrating medication overuse headache.
Show all 10Show fewer
- Currently has uncontrolled narrow angle glaucoma.
- Currently taking monoamine oxidase inhibitors.
- Subject has a history of seizures.
- Participation in an investigational drug study within the last 30 days or 5 half-lives, whichever is longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Medical Clinic for Headache
Santa Monica, California, 90404
Tatyana Neyman, MD, 310-315-1456, tneyman@drkudrow.com
Alan Rapoport, MD
About this study
Official title: Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine.
This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers.
Read the detailed description
Patients with episodic migraine with and/or without aura and chronic migraine will be treated with 100 or 200 mg of milnacipran for a total of 4 months including a one month titration phase and a 3 month maintenance phase. Baseline (pre-treatment) and end-of-maintenance phase headache frequencies will be recorded. There is no placebo treatment in this study. In addition to headache frequencies, other parameters being measured include safety and tolerability.
- Conditions
- Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Being tested
- milnacipran
- Medical subject headings
- Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milnacipranDrug
100 mg and 200 mg orally daily for a total of 4 months including a one month titration period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline
Measured: 4 months
Secondary outcomes (6)
Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.
Measured: 4 months
Improvement in headache index score
Headache index is defined by headache severity x headache duration.
Measured: 4 months
Reduction in the number of days of headache related disability/impairment
Measured: 4 months
Tolerability
Assessment of adverse events
Measured: 4 months
Use of rescue medications
To assess the continued need for acute headache treatments during the study period.
Measured: 4 months
Quality of life measures
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2012 (estimated)
- Study completionJul 2012 (estimated)
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 Migraine With AuraStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Medical Clinic for Headache
- Sponsor type
- University, hospital or other
- Investigators
- David B Kudrow, MD, Principal investigator, California Medical Clinic for Headache
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319825
- Sponsor's protocol ID
- SAV-MD-26
- Status last verified
- Mar 2011
- First submitted
- 18 Mar 2011
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Engel ER, Kudrow D, Rapoport AM. A prospective, open-label study of milnacipran in the prevention of headache in patients with episodic or chronic migraine. Neurol Sci. 2014 Mar;35(3):429-35. doi: 10.1007/s10072-013-1536-0. Epub 2013 Sep 13.
PubMed 24030685
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine.
- ClinicalTrials.gov ID
- NCT01319825
- Acronym / sponsor ID
- SAV-MD-26
- Conditions
- Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- California Medical Clinic for HeadacheUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 22 Mar 2011 (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.
This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers.
Detailed description
Patients with episodic migraine with and/or without aura and chronic migraine will be treated with 100 or 200 mg of milnacipran for a total of 4 months including a one month titration phase and a 3 month maintenance phase. Baseline (pre-treatment) and end-of-maintenance phase headache frequencies will be recorded. There is no placebo treatment in this study. In addition to headache frequencies, other parameters being measured include safety and tolerability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Migraine with or without aura or chronic migraine.
- Subject age 18 to 70.
- At least 2 migraine attacks per month.
- Willing ang able to give written informed consent.
- Willing and able to complete the entire course of the study and to comply with study instructions.
Key exclusion criteria (10 listed)
- Subject is pregnant, lactating or planning a pregnancy in the next year.
- Subject is female of child-bearing potential and not taking adequate forms of birth control.
- Significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.
- Previous failure of four or more adequate trials of preventive medication.
- Currently on any form of antidepressant for depression and not able to discontinue.
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 |
|---|---|---|
| milnacipran100 mg and 200 mg orally daily for a total of 4 months including a one month titration period. | Drug | – |
Primary outcome
Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline
Time frame: 4 months
6 secondary outcomes
Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.
Time frame: 4 months
Improvement in headache index score
Time frame: 4 months
Reduction in the number of days of headache related disability/impairment
Time frame: 4 months
Tolerability
Time frame: 4 months
Use of rescue medications
Time frame: 4 months
Quality of life measures
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
- Derived from this study: PubMed 24030685Engel ER, Kudrow D, Rapoport AM. A prospective, open-label study of milnacipran in the prevention of headache in patients with episodic or chronic migraine. Neurol Sci. 2014 Mar;35(3):429-35. doi: 10.1007/s10072-013-1536-0. Epub 2013 Sep 13.
- California Medical Clinic for HeadacheLink provided by the sponsor.
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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.
David B Kudrow, MD principal investigator
California Medical Clinic for Headache
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 milnacipran in people with Migraine With Aura and Migraine Without Aura, run by California Medical Clinic for Headache 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David B Kudrow, MD (310-315-1456, dbkudrow@earthlink.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline (time frame: 4 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 NCT01319825, 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 Mar 2011.