Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?

NCT ID: NCT01161017

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2014-05-31

Brief Summary

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Mechanism-based choice of therapy for pain:

Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?

Detailed Description

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Conditions

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Migraine

Keywords

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migraine patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1 Amitriptyline.

Amitriptyline

Group Type ACTIVE_COMPARATOR

Amitriptyline

Intervention Type DRUG

Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks

2 Topiramate

Topiramate

Group Type ACTIVE_COMPARATOR

Topiramate

Intervention Type DRUG

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

Interventions

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Amitriptyline

Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks

Intervention Type DRUG

Topiramate

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female and male migraine patients with a number of month attacks ≥ 4,
* age 18-75,
* without any other chronic pain.

Exclusion Criteria

* any migraine preventive treatment for last 6 month \& psychiatric,
* language or cognitive dysfunction precluding use of psychophysics.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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d_yarnitsky

Head of Neurology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Migraine06CTIL

Identifier Type: -

Identifier Source: org_study_id