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Galantamine in the Treatment of Post-Traumatic Headache

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ClinicalTrials.gov Identifier: NCT00219869
Recruitment Status : Unknown
Verified September 2005 by Rapoport, Alan, M.D..
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Rapoport, Alan, M.D.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date September 22, 2005
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Primary Headache Efficacy Measure; number of pain free days after 3 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Consumption of rescue medication
  • Number of days with moderate or severe headache after 3 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Galantamine in the Treatment of Post-Traumatic Headache
Official Title  ICMJE Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Post-Traumatic Headache
  • Head Trauma,Closed
  • Retention Disorders,Cognitive
Intervention  ICMJE Drug: Galantamine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 13, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00219869
Other Study ID Numbers  ICMJE GAL-EMR-4006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rapoport, Alan, M.D.
Collaborators  ICMJE Ortho-McNeil Neurologics, Inc.
Investigators  ICMJE
Principal Investigator: Alan Rapoport, MD The New England Center for Headache
PRS Account Rapoport, Alan, M.D.
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP