Detoxification and Treatment of Subjects With Medication... | NCT00432549

Studies
Detoxification and Treatment of Subjects With Medication Overuse Headache

NCT00432549

Sponsor

The New England Center for Headache, P.C.

Status

Unknown status

Last Update Posted

Feb 8, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Analgesic Rebound Headache

Interventions

Almotriptan
Topiramate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Feb 2007

First Submitted Date

Feb 6, 2007

First Submission Date that Met QC Criteria

Feb 7, 2007

First Posted Date

Feb 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2007

Last Update Posted Date

Feb 8, 2007Estimated

Name	Class
Ortho-McNeil Neurologics, Inc.	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alfredo DaSilva	Contact	203-322-2748		adasilva@nech.net
Jo-Ann Epstein	Contact	203-322-2748		jepstein@nech.net

Overall Officials

Name	Affiliation	Role
Fred D Sheftell, M.D.	The New England Center for Headache, P.C.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The New England Center for Headache, P.C.	Recruiting	Stamford	Connecticut	06902	United States

Condition Browse Module

MeSH Terms

ID	Term
D051271	Headache Disorders, Secondary
D000067490	Prescription Drug Overuse

Ancestor Terms

ID	Term
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C409045	almotriptan
D000077236	Topiramate

Ancestor Terms

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241

Browse Leaves

Not provided

Browse Branches

Not provided