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
Ortho-McNeil Neurologics, Inc.
Information provided by:
Rapoport, Alan, M.D. Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00219869

Contact: Lori L Flanagan, RN 203-322-2748
Contact: Kathy Diomede, RN 203-322-2748

United States, Connecticut
The New England Center for Headache Recruiting
Stamford, Connecticut, United States, 06902
Contact: Lori Flanagan, RN    203-322-2748   
Contact: Kathy Diomede    203-322-2748   
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.
Principal Investigator: Alan Rapoport, MD The New England Center for Headache
  More Information 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.:

Additional relevant MeSH terms:
Post-Traumatic Headache
Headache Disorders
Headache Disorders, Secondary
Head Injuries, Closed
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating
Autonomic Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 26, 2016