Galantamine in the Treatment of Post-Traumatic Headache

September 13, 2005 updated by: Rapoport, Alan, M.D.

Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • The New England Center for Headache
        • Contact:
          • Lori Flanagan, RN
          • Phone Number: 203-322-2748
          • Email: lc@nech.net
        • Contact:
          • Kathy Diomede
          • Phone Number: 203-322-2748
          • Email: kd@nech.net
        • Principal Investigator:
          • Alan Rapoport, MD
        • Sub-Investigator:
          • Stewart Tepper, MD
        • Sub-Investigator:
          • Fred Sheftell, MD
        • Sub-Investigator:
          • Marcelo Bigal, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Consumption of rescue medication
Number of days with moderate or severe headache after 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rapoport, Alan, M.D.

Collaborators

Ortho-McNeil Neurologics, Inc.

Investigators

  • Principal Investigator: Alan Rapoport, MD, The New England Center for Headache

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2005

Last Update Submitted That Met QC Criteria

September 13, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAL-EMR-4006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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