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Galantamine in the Treatment of Post-Traumatic Headache

Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00219869
Enrollment
30
Registered
2005-09-22
Start date
2005-07-31
Completion date
2005-08-31
Last updated
2005-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Trauma,Closed, Post-Traumatic Headache, Retention Disorders,Cognitive

Keywords

Post, Traumatic, Headache, Cognitive

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.

Interventions

DRUGGalantamine

Sponsors

Ortho-McNeil Neurologics, Inc.
CollaboratorINDUSTRY
Rapoport, Alan, M.D.
Lead SponsorINDIV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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 \-

Design outcomes

Primary

MeasureTime frame
Primary Headache Efficacy Measure; number of pain free days after 3 months

Secondary

MeasureTime frame
Consumption of rescue medication
Number of days with moderate or severe headache after 3 months.

Countries

United States

Contacts

Primary ContactLori L Flanagan, RN
lc@nech.net203-322-2748
Backup ContactKathy Diomede, RN
kd@nech.net203-322-2748

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026