Galantamine in the Treatment of Post-Traumatic Headache

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Rapoport, Alan, M.D..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Rapoport, Alan, M.D.
ClinicalTrials.gov Identifier:
NCT00219869
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00219869     History of Changes
Other Study ID Numbers: GAL-EMR-4006
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Craniocerebral Trauma
Head Injuries, Closed
Headache
Memory Disorders
Post-Traumatic Headache
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Neurobehavioral Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Wounds, Nonpenetrating
Galantamine
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents

ClinicalTrials.gov processed this record on July 22, 2014