MigraineNCT01161017
Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
A study testing Amitriptyline and Topiramate in people with Migraine, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Mechanism-based choice of therapy for pain: Can successful prevention of migraine be coupled to a psychophysical pain modulation profile? Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- Amitriptyline and Topiramate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to May 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female and male migraine patients with a number of month attacks ≥ 4,
- age 18-75,
- without any other chronic pain.
Who cannot join
- any migraine preventive treatment for last 6 month \& psychiatric,
- language or cognitive dysfunction precluding use of psychophysics.
Trial locations and contacts
1 site in 1 country.
About this study
Mechanism-based choice of therapy for pain:
Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?
- Conditions
- Migraine
- Being tested
- Amitriptyline, Topiramate
- Keywords
- migraine patients
- 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
Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks
TopiramateDrug
For the first 5 days of treatment 25mg is prescribed and should be ingested in one evening dose. For another 5 days, 25g dose should be taken twice a day (morning and evening). For the next 5 days, morning dose will be 25mg; evening dose will be 50mg. For the remaining 6 weeks of treatment, a dose of 50mg twice a day will be advised
| Study group | Role | What they receive |
|---|---|---|
| 1 Amitriptyline. | Active comparator | Amitriptyline Receives: Drug: Amitriptyline |
| 2 Topiramate | Active comparator | Topiramate Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic response to the analgesic drugs
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2008
- Primary completionMay 2014
- Study completionMay 2014
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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, d_yarnitsky, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161017
- Sponsor's protocol ID
- Migraine06CTIL
- Status last verified
- Oct 2017
- First submitted
- 10 Jul 2010
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
- ClinicalTrials.gov ID
- NCT01161017
- Acronym / sponsor ID
- Migraine06CTIL
- Conditions
- Migraine
- Keywords
- migraine patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2008 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Jul 2010 (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.
Mechanism-based choice of therapy for pain:
Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?
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 |
|---|---|---|
| 1 Amitriptyline. | Active comparator | Drug: AmitriptylineAmitriptyline |
| 2 Topiramate | Active comparator | Drug: TopiramateTopiramate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female and male migraine patients with a number of month attacks ≥ 4,
- age 18-75,
- without any other chronic pain.
Key exclusion criteria (2 listed)
- any migraine preventive treatment for last 6 month \& psychiatric,
- language or cognitive dysfunction precluding use of psychophysics.
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 |
|---|---|---|
| AmitriptylineInitial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks | Drug | 1 Amitriptyline. |
| TopiramateFor the first 5 days of treatment 25mg is prescribed and should be ingested in one evening dose. For another 5 days, 25g dose should be taken twice a day (morning and evening). For the next 5 days, morning dose will be 25mg; evening dose will be 50mg. For the remaining 6 weeks of treatment, a dose of 50mg twice a day will be advised | Drug | 2 Topiramate |
Primary outcome
Therapeutic response to the analgesic drugs
Time frame: 2 months
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 11 Oct 2017.
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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 Amitriptyline and Topiramate in people with Migraine, 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 3 inclusion and 2 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 11 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. 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 months). 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 11 Oct 2017.