MedPath

Galantamine in the Treatment of Post-Traumatic Headache

Phase 4
Conditions
Post-Traumatic Headache
Head Trauma,Closed
Retention Disorders,Cognitive
Registration Number
NCT00219869
Lead Sponsor
Rapoport, Alan, M.D.
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).

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Primary Headache Efficacy Measure; number of pain free days after 3 months
Secondary Outcome Measures
NameTimeMethod
Consumption of rescue medication
Number of days with moderate or severe headache after 3 months.

Trial Locations

Locations (1)

The New England Center for Headache

🇺🇸

Stamford, Connecticut, United States

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