NCT01161017

Brief Summary

Mechanism-based choice of therapy for pain: Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

5.8 years

First QC Date

July 10, 2010

Last Update Submit

October 10, 2017

Conditions

Migraine

Keywords

migraine patients

Outcome Measures

Primary Outcomes (1)

  • Therapeutic response to the analgesic drugs

    2 months

Study Arms (2)

1 Amitriptyline.

ACTIVE COMPARATOR

Amitriptyline

Drug: Amitriptyline

2 Topiramate

ACTIVE COMPARATOR

Topiramate

Drug: Topiramate

Interventions

AmitriptylineDRUG

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

1 Amitriptyline.
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

2 Topiramate

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

AmitriptylineTopiramate

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsFructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology Department

Study Record Dates

First Submitted

July 10, 2010

First Posted

July 13, 2010

Study Start

July 1, 2008

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

IL(1)