We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Galantamine in the Treatment of Post-Traumatic Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Head Trauma,Closed Retention Disorders,Cognitive Drug: Galantamine Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache
Study Start Date : July 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Primary Headache Efficacy Measure; number of pain free days after 3 months

Secondary Outcome Measures :
  1. Consumption of rescue medication
  2. Number of days with moderate or severe headache after 3 months.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219869


Contacts
Layout table for location contacts
Contact: Lori L Flanagan, RN 203-322-2748 lc@nech.net
Contact: Kathy Diomede, RN 203-322-2748 kd@nech.net

Locations
Layout table for location information
United States, Connecticut
The New England Center for Headache Recruiting
Stamford, Connecticut, United States, 06902
Contact: Lori Flanagan, RN    203-322-2748    lc@nech.net   
Contact: Kathy Diomede    203-322-2748    kd@nech.net   
Principal Investigator: Alan Rapoport, MD         
Sub-Investigator: Stewart Tepper, MD         
Sub-Investigator: Fred Sheftell, MD         
Sub-Investigator: Marcelo Bigal, MD, PhD         
Sponsors and Collaborators
Rapoport, Alan, M.D.
Ortho-McNeil Neurologics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Alan Rapoport, MD The New England Center for Headache
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00219869    
Other Study ID Numbers: GAL-EMR-4006
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005
Keywords provided by Rapoport, Alan, M.D.:
Post
Traumatic
Headache
Cognitive
Additional relevant MeSH terms:
Layout table for MeSH terms
Craniocerebral Trauma
Post-Traumatic Headache
Memory Disorders
Head Injuries, Closed
Headache
Pain
Neurologic Manifestations
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
 Neurobehavioral Manifestations
Wounds, Nonpenetrating
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents