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Galantamine in the Treatment of Post-Traumatic Headache

NCT ID: NCT00219869

Last Updated: 2005-09-22

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-08-31

Brief Summary

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Most patients with CPTH present with additional major cognitive, behavioral and somatic problems. Most drugs used currently have a negative influence on cognition. Therefore, treatment strategies addressing both the headache and cognitive disturbances in patients with CPTH are necessary. (CPTH; Chronic Post Traumatic Headache).

Detailed Description

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Headache is the most common symptom after a closed head injury, persisting for more then 2 months in 60% of the patients. CPTH is an important cause of consultations in neurology offices and headache clinics, posing a severe burden and affecting the quality of life of sufferers.

Conditions

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Post-Traumatic Headache Head Trauma,Closed Retention Disorders,Cognitive

Keywords

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Post Traumatic Headache Cognitive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Galantamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Age range 18-75 CPTH according to ICHD-2 Fertile woman using adequate birth control Willing and able to give informed consent Willing and able to complete the entire course of the study to comply with study instructions Stable does of preventive medication

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Exclusion Criteria

Subject is pregnant or lactating Significant medical or psychiatric disease Previous failure to 4 or more adequate trials of preventive medication Patient on non-stable dose of medication used to prevent CPTH

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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role collaborator

Rapoport, Alan, M.D.

INDIV

Sponsor Role lead

Principal Investigators

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Alan Rapoport, MD

Role: PRINCIPAL_INVESTIGATOR

The New England Center for Headache

Locations

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The New England Center for Headache

Stamford, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lori L Flanagan, RN

Role: CONTACT

Phone: 203-322-2748

Email: [email protected]

Kathy Diomede, RN

Role: CONTACT

Phone: 203-322-2748

Email: [email protected]

Facility Contacts

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Lori Flanagan, RN

Role: primary

Kathy Diomede

Role: backup

Related Links

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http://www.headachenech.com

The New England Center for Headache page

Other Identifiers

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GAL-EMR-4006

Identifier Type: -

Identifier Source: org_study_id