Galantamine in the Treatment of Post-Traumatic Headache

Post-Traumatic Headache Clinical Trial

Official title:

Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00219869
• Other study ID #: GAL-EMR-4006
• Status: Recruiting
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: July 2005
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: Rapoport, Alan, M.D.
• Contact: Lori L Flanagan, RN
• Phone: 203-322-2748
• Email: lc[@]nech.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Injuries, Closed
• Head Trauma,Closed
• Headache
• Memory Disorders
• Post-Traumatic Headache
• Retention Disorders,Cognitive

Intervention

Drug:
• Galantamine

Locations

Country	Name	City	State
United States	The New England Center for Headache	Stamford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Rapoport, Alan, M.D.	Ortho-McNeil Neurologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Headache Efficacy Measure; number of pain free days after 3 months
Secondary	Consumption of rescue medication
Secondary	Number of days with moderate or severe headache after 3 months.