NCT00432549

Brief Summary

The purpose of this study is to assess the benefits of almotriptan used as a transitional therapy and topiramate in subjects with medication overuse headaches (MOH.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
Last Updated

February 8, 2007

Status Verified

February 1, 2007

First QC Date

February 6, 2007

Last Update Submit

February 7, 2007

Conditions

Analgesic Rebound Headache

Keywords

Medication overuse

Outcome Measures

Primary Outcomes (4)

  • Primary measure for the detoxification period

  • Number of days with mild or no pain in the first two weeks of treatment

  • Primary for the prevention of relapse

  • Pain free days through day ninety

Secondary Outcomes (4)

  • Primary measure for the detoxification period

  • Number of days without any headache in the first two weeks of treatment

  • Primary for the prevention of relapse

  • Headache frequency through day ninety

Interventions

AlmotriptanDRUG
TopiramateDRUG

Eligibility Criteria

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

You may qualify if:

  • Medication overuse headaches 18 years of age and older Must have a diagnosis of probable medication overuse headache Must have greater than fifteen headache days per month Must be in generally good health Female subjects must be postmenopausal or practicing an acceptable method of birth control

You may not qualify if:

  • Not overusing six or more tablets per day of compounds containing barbituates opioids No overuse of triptans Previous failure or side effects with topiramate or almotriptan Cannot be pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New England Center for Headache, P.C.

Stamford, Connecticut, 06902, United States

RECRUITING

MeSH Terms

Conditions

Headache Disorders, SecondaryPrescription Drug Overuse

Interventions

almotriptanTopiramate

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPrescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Fred D Sheftell, M.D.

    The New England Center for Headache, P.C.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfredo DaSilva

CONTACT

203-322-2748adasilva@nech.net

Jo-Ann Epstein

CONTACT

203-322-2748jepstein@nech.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 8, 2007

Study Start

January 1, 2007

Study Completion

February 1, 2007

Last Updated

February 8, 2007

Record last verified: 2007-02

Locations

US(1)