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Galantamine in the Treatment of Post-Traumatic Headache

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Rapoport, Alan, M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219869
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
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.
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Rapoport, Alan, M.D.
  Purpose
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 Intervention Phase
Post-Traumatic Headache Head Trauma,Closed Retention Disorders,Cognitive Drug: Galantamine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rapoport, Alan, M.D.:

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.

Estimated Enrollment: 30
Study Start Date: July 2005
Estimated Study Completion Date: August 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
Contact: Lori L Flanagan, RN 203-322-2748 lc@nech.net
Contact: Kathy Diomede, RN 203-322-2748 kd@nech.net

Locations
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
Principal Investigator: Alan Rapoport, MD The New England Center for Headache
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00219869     History of Changes
Other Study ID Numbers: GAL-EMR-4006
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Rapoport, Alan, M.D.:
Post
Traumatic
Headache
Cognitive

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Headache Disorders, Secondary
Headache Disorders
Craniocerebral Trauma
Memory Disorders
Head Injuries, Closed
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
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