MigraineNCT01470352
Multiparametric MRI Study of Endogenous Analgesia and Prediction the Efficacy of Migraine Pharmacological Prevention
A study testing Doluxetine in people with Migraine, run by d_yarnitsky at 1 site in Israel.
Trial summary
To delineate brain mechanisms that subserve EA in the healthy state and to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. Individuals with migraine will be examined between episodes in order to assess basal alterations in the efficiency of spatial and temporal… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Doluxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Nov 2011to 6 Nov 2017
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients diagnosed with migraine based on the International Headache Society (IHS) criteria 1 that have >4 attacks/month, both with and without aura
Who cannot join
- patients receiving any migraine preventive treatment during last 3 months or prior treatment with amytriptiline
- other chronic pain conditions
- psychiatric, other neurological diseases, language barrier or cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
To delineate brain mechanisms that subserve EA in the healthy state and to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. Individuals with migraine will be examined between episodes in order to assess basal alterations in the efficiency of spatial and temporal filtering of noxious information. This population provides the unique opportunity to examine such processes without confounds arising from ongoing pain.
Read the detailed description
Pain is a uniquely individual experience that is powerfully shaped by the action of descending control mechanisms. These systems may play crucial roles in the moment-to-moment tuning of the sensitivity, spatial, and temporal response characteristics of nociceptive processing mechanisms during both acute and pathological pain states. However, these systems remain poorly understood in human subjects. The proposed research will use psychophysics and multiparametric MRI to (i) delineate the brain mechanisms that subserve and regulate endogenous analgesia (EA) in the healthy state and (ii) to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. In both healthy subjects and chronic pain patients, EA will be probed using the DNIC (diffuse noxious inhibitory controls) and offset analgesia paradigms. Functional MRI will examine activation of brainstem mechanisms important in EA, while both functional and structural connectivity analyses will assess the regulation of these brainstem mechanisms by cerebral cortical regions involved in attention and affect. One pathological painful condition, migraine, will be examined since it allows changes in EA associated with chronic pain to be investigated between episodes of pain. Finally, EA and EA associated structural and functional parameters will be used to predict the efficacy of one compound, amitriptyline, to treat migraine in individual patients. Taken together, the proposed research will provide substantial insights into basic mechanisms supporting and regulating EA and can provide a foundation for mechanism-based individualized choice of therapy that may benefit all chronic pain patients.
- Conditions
- Migraine
- Being tested
- Doluxetine, Placebo
- Keywords
- migraine, pain, CPM, offset analgesia, fMRI
- Medical subject headings
- Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoluxetineDrug
Also called duloxetine
30 mg/d
PlaceboDrug
Also called sugar
suger pill 30mg/d
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Doluxetine; Drug: Placebo |
| treatment | Active comparator | Duloxetine will be given in a daily dose of 30 mg for 5 weeks Receives: Drug: Doluxetine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic response to the analgesic drugs
The level of pain relief
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study start16 Nov 2011
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- d_yarnitsky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, d_yarnitsky, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470352
- Sponsor's protocol ID
- Migrain-0265-11CTIL
- Status last verified
- Mar 2019
- First submitted
- 9 Nov 2011
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI Study of Endogenous Analgesia and Prediction the Efficacy of Migraine Pharmacological Prevention
- ClinicalTrials.gov ID
- NCT01470352
- Acronym / sponsor ID
- Migrain-0265-11CTIL
- Conditions
- Migraine
- Keywords
- migraine, pain, CPM, offset analgesia, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- d_yarnitskyUniversity, hospital or other
- Study start
- 16 Nov 2011 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 11 Nov 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.
To delineate brain mechanisms that subserve EA in the healthy state and to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. Individuals with migraine will be examined between episodes in order to assess basal alterations in the efficiency of spatial and temporal filtering of noxious information. This population provides the unique opportunity to examine such processes without confounds arising from ongoing pain.
Detailed description
Pain is a uniquely individual experience that is powerfully shaped by the action of descending control mechanisms. These systems may play crucial roles in the moment-to-moment tuning of the sensitivity, spatial, and temporal response characteristics of nociceptive processing mechanisms during both acute and pathological pain states. However, these systems remain poorly understood in human subjects. The proposed research will use psychophysics and multiparametric MRI to (i) delineate the brain mechanisms that subserve and regulate endogenous analgesia (EA) in the healthy state and (ii) to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. In both healthy subjects and chronic pain patients, EA will be probed using the DNIC (diffuse noxious inhibitory controls) and offset analgesia paradigms. Functional MRI will examine activation of brainstem mechanisms important in EA, while both functional and structural connectivity analyses will assess the regulation of these brainstem mechanisms by cerebral cortical regions involved in attention and affect. One pathological painful condition, migraine, will be examined since it allows changes in EA associated with chronic pain to be investigated between episodes of pain. Finally, EA and EA associated structural and functional parameters will be used to predict the efficacy of one compound, amitriptyline, to treat migraine in individual patients. Taken together, the proposed research will provide substantial insights into basic mechanisms supporting and regulating EA and can provide a foundation for mechanism-based individualized choice of therapy that may benefit all chronic pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Doluxetine, Drug: Placebo |
| treatment | Active comparator | Drug: Doluxetine, Drug: PlaceboDuloxetine will be given in a daily dose of 30 mg for 5 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients diagnosed with migraine based on the International Headache Society (IHS) criteria 1 that have >4 attacks/month, both with and without aura
Key exclusion criteria (3 listed)
- patients receiving any migraine preventive treatment during last 3 months or prior treatment with amytriptiline
- other chronic pain conditions
- psychiatric, other neurological diseases, language barrier or cognitive dysfunction
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 |
|---|---|---|
| DoluxetineAlso: duloxetine30 mg/d | Drug | Placebo, treatment |
| PlaceboAlso: sugarsuger pill 30mg/d | Drug | Placebo, treatment |
Primary outcome
Therapeutic response to the analgesic drugs
Time frame: 2 month
The level of pain relief
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 27 Mar 2019.
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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 study testing Doluxetine in people with Migraine, run by d_yarnitsky at 1 site in Israel.
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 1 inclusion and 3 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 27 Mar 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 Israel. 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.
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?
Therapeutic response to the analgesic drugs (time frame: 2 month). 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 27 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.