Back to resultsGalantamine in the Treatment of Post-Traumatic Headache
Primary Purpose
Post-Traumatic Headache, Head Trauma,Closed, Retention Disorders,Cognitive
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Galantamine
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Headache focused on measuring Post, Traumatic, Headache, Cognitive
Eligibility Criteria
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 - 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 -
Sites / Locations
- The New England Center for HeadacheRecruiting
Outcomes
Primary Outcome Measures
Primary Headache Efficacy Measure; number of pain free days after 3 months
Secondary Outcome Measures
Consumption of rescue medication
Number of days with moderate or severe headache after 3 months.
Full Information
NCT ID
NCT00219869
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Rapoport, Alan, M.D.
Collaborators
Ortho-McNeil Neurologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00219869
Brief Title
Galantamine in the Treatment of Post-Traumatic Headache
Official Title
Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rapoport, Alan, M.D.
Collaborators
Ortho-McNeil Neurologics, Inc.
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Headache, Head Trauma,Closed, Retention Disorders,Cognitive
Keywords
Post, Traumatic, Headache, Cognitive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Galantamine
Primary Outcome Measure Information:
Title
Primary Headache Efficacy Measure; number of pain free days after 3 months
Secondary Outcome Measure Information:
Title
Consumption of rescue medication
Title
Number of days with moderate or severe headache after 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
-
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lori L Flanagan, RN
Phone
203-322-2748
Email
lc@nech.net
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Diomede, RN
Phone
203-322-2748
Email
kd@nech.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Rapoport, MD
Organizational Affiliation
The New England Center for Headache
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New England Center for Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Flanagan, RN
Phone
203-322-2748
Email
lc@nech.net
First Name & Middle Initial & Last Name & Degree
Kathy Diomede
Phone
203-322-2748
Email
kd@nech.net
First Name & Middle Initial & Last Name & Degree
Alan Rapoport, MD
First Name & Middle Initial & Last Name & Degree
Stewart Tepper, MD
First Name & Middle Initial & Last Name & Degree
Fred Sheftell, MD
First Name & Middle Initial & Last Name & Degree
Marcelo Bigal, MD, PhD
12. IPD Sharing Statement
Links:
URL
http://www.headachenech.com
Description
The New England Center for Headache page
Learn more about this trial
Galantamine in the Treatment of Post-Traumatic Headache
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