MigraineNCT02101892
Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation
A study testing Amitriptyline in people with Migraine and Preventive Treatment, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
A major reason for the substantial underuse of pharmacological prevention of migraine is its inadequate efficacy, since only ~50% of patients respond to a specific agent. There is currently no evidence-based way to identify the patients that will respond to a specific preventive treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Migraine, Preventive Treatment
- What is being tested?
- Amitriptyline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Feb 2016
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18
- premenopausal
- meeting the international headache society criteria for migraine
- having >4 attacks or days of migraine/month
Who cannot join
- baseline month diary indicating lower frequency of migraine
- chronic migraine (>15 days of headache per month)
- use of migraine preventive treatment during previous 3 month
- language barrier or cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Migraine Prevention Efficacy: Individualization of Treatment by Coupling Drug's Mode of Action With Patient's Mechanism of Pain Modulation
A major reason for the substantial underuse of pharmacological prevention of migraine is its inadequate efficacy, since only ~50% of patients respond to a specific agent. There is currently no evidence-based way to identify the patients that will respond to a specific preventive treatment. Amitriptyline is one of the commonest agents used for migraine prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of analgesics according to pain inhibitory capacity has been shown effective by our group for painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition capacity gained more from a drug that augment pain inhibition as compared to those with efficient inhibitory capacity. The investigators now propose to assess migraineurs for their pain inhibition capacity, and examine whether, along similar reasoning, those with reduced inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs, who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized two arms parallel double blind design, and followed up for attacks reduction. The investigators expect to identify the best predictors for efficacy of migraine prevention by the study drug. This approach will promote individualization of migraine therapy.
- Conditions
- Migraine, Preventive Treatment
- Being tested
- Amitriptyline, placebo
- Keywords
- migraine, Amitriptyline, pain modulation, pain psychophysics, pain neurophysiology, preventive treatment
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Also called Elatrol
per os, daily, evening
placeboDrug
Also called sugar pills
per os, daily, evening
| Study group | Role | What they receive |
|---|---|---|
| Amitriptyline | Active comparator | Amitriptyline, 25 mg per os, daily, evening, for 8 weeks; starting dose is 12.5 mg for 2 days Receives: Drug: placebo |
| placebo | Placebo comparator | sugar pills Receives: Drug: Amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment
ANCOVA will be utilized, based on factors treatment (amitriptyline or placebo), conditioned pain modulation capabilities (responder or non-responder), their interaction, a number of covariates, to predict reduction attacks.
Measured: one year
Secondary outcomes (1)
predictive value of pain-related psychological parameters for benefit from amitriptyline treatment
The scores for Spielberger's anxiety state and trait questionnaire, and for pain catastrophising questionnaire will be used.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
- Study completionFeb 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Migraine Research Foundation
- Responsible party
- Sponsor
- Investigators
- David Yarnitsky, MD, Professor, Principal investigator, Rambam Health Care Campus and Technion Medical SchoolYelena Granovsky, PhD, Principal investigator, Rambam Health Care Campus and Technion Medical SchoolMichal Granot, Professor, Principal investigator, Nursing School, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101892
- Sponsor's protocol ID
- 0102-14
- Status last verified
- Oct 2017
- First submitted
- 18 Mar 2014
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Migraine Prevention Efficacy: Individualization of Treatment by Coupling Drug's Mode of Action With Patient's Mechanism of Pain Modulation
- ClinicalTrials.gov ID
- NCT02101892
- Acronym / sponsor ID
- 0102-14
- Conditions
- Migraine, Preventive Treatment
- Keywords
- migraine, Amitriptyline, pain modulation, pain psychophysics, pain neurophysiology, preventive treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Migraine Research Foundation
- Study start
- Apr 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Apr 2014 (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.
A major reason for the substantial underuse of pharmacological prevention of migraine is its inadequate efficacy, since only ~50% of patients respond to a specific agent. There is currently no evidence-based way to identify the patients that will respond to a specific preventive treatment. Amitriptyline is one of the commonest agents used for migraine prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of analgesics according to pain inhibitory capacity has been shown effective by our group for painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition capacity gained more from a drug that augment pain inhibition as compared to those with efficient inhibitory capacity. The investigators now propose to assess migraineurs for their pain inhibition capacity, and examine whether, along similar reasoning, those with reduced inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs, who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized two arms parallel double blind design, and followed up for attacks reduction. The investigators expect to identify the best predictors for efficacy of migraine prevention by the study drug. This approach will promote individualization of migraine therapy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amitriptyline | Active comparator | Drug: placeboAmitriptyline, 25 mg per os, daily, evening, for 8 weeks; starting dose is 12.5 mg for 2 days |
| placebo | Placebo comparator | Drug: Amitriptylinesugar pills |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >18
- premenopausal
- meeting the international headache society criteria for migraine
- having >4 attacks or days of migraine/month
Key exclusion criteria (4 listed)
- baseline month diary indicating lower frequency of migraine
- chronic migraine (>15 days of headache per month)
- use of migraine preventive treatment during previous 3 month
- 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 |
|---|---|---|
| AmitriptylineAlso: Elatrolper os, daily, evening | Drug | placebo |
| placeboAlso: sugar pillsper os, daily, evening | Drug | Amitriptyline |
Primary outcome
predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment
Time frame: one year
ANCOVA will be utilized, based on factors treatment (amitriptyline or placebo), conditioned pain modulation capabilities (responder or non-responder), their interaction, a number of covariates, to predict reduction attacks.
1 secondary outcome
predictive value of pain-related psychological parameters for benefit from amitriptyline treatment
Time frame: one year
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 3 Oct 2017.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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 Yarnitsky, MD, Professor principal investigator
Rambam Health Care Campus and Technion Medical School
Yelena Granovsky, PhD principal investigator
Rambam Health Care Campus and Technion Medical School
Michal Granot, Professor principal investigator
Nursing School, University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amitriptyline in people with Migraine and Preventive Treatment, run by Rambam Health Care Campus 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 4 inclusion and 4 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 3 Oct 2017. 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?
predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment (time frame: one year). 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 Oct 2017.