Clinical Trial: Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Evaluation of the Efficacy of Naratriptan for the Treatment and Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

Brief Summary: The purpose of this study is to determine whether naratriptan, a medication approved for treatment of migraine, is effective in the treatment of post traumatic headache associated with cognitive dysfunction.

Detailed Summary:

Naratriptan has demonstrated efficacy in relieving headache. Other studies have demonstrated that primary headaches with at least one headache feature are likely to respond to triptans. In addition, there are anecdotal reports of triptans being effective in post traumatic headaches, especially if headache features are noted in the patient's history. Further, there are several small pilot studies with triptans demonstrating a prompt improvement in headache-induced cognitive changes. Cognitive performance can be measured by the Mental Efficiency Workload Test (MEWT), a handheld Palm neuropsychological test battery that measures mental efficiency. This tool can be used to demonstrate short and long term improvement in mental status beyond that seen at baseline.

Informal observations by the protocol authors have suggested that the use of triptans on a routine basis may ameliorate the headache and associated symptomatology of post traumatic headache. Therefore, this study is undertaken to study the use of naratriptan in the treatment of post traumatic headache. Roger K. Cady, MD, serves as the sponsor. The study is funded by GlaxoSmithKline.

56 subjects with a formal diagnosis of Chronic post-traumatic headache attributed to mild head injury (IHS/ICHD-II 5.2.2) and with self-reported mild cognitive inefficiency secondary to headache will be enrolled. Subjects meeting inclusion criteria will complete a physical examination and baseline testing and be randomized 1:1 to naratriptan 2.5mg bid x 30 days or a matched placebo bid x 30 days. A daily diary will document response to treatment. Subjects will return to the clinic at Day 10 and Day 30 and complete phone contacts at Days 5, 15, 21, 32 and 90. Information will be collected throughout the study on questionnaires related to headache impact, general health, satisfaction with med
Sponsor: Cady, Roger, M.D.

Current Primary Outcome:

  • Headache Days [ Time Frame: Day 30 ]
    Number of headache days as measured by the Headache Diary
  • Headache Impact Test-6 (HIT-6) Score [ Time Frame: Day 0, Day 30 ]
    Impact of headache symptoms on subject's life as measured by HIT-6 questionnaire scores. Possible scores range from 36 to 78. Score of 48 or less indicates headache has little impact on life. Score of 60-78 indicative of very severe impact.
  • Mental Efficiency Workload Test (MEWT) Performance Index Score [ Time Frame: Day 0, Day 10, Day 30 ]
    Cognitive function as measured by Performance Index scores on the Mental Efficiency Workload Test (MEWT). On the performance index scale of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. Tests include: Simple reaction time, Running memory, Matching to sample, Math processing and a sleep scale.


Original Primary Outcome:

  • Number of headache days as measured by the Headache Diary [ Time Frame: Day 30 ]
  • Impact of headache symptoms as measured by the HIT-6 questionnaire [ Time Frame: Day 0, Day 30 ]
  • Cognitive function as measured by Mental Efficiency Workload Test (MEWT) [ Time Frame: Day 0, Day 10, Day 30 ]


Current Secondary Outcome:

  • Overall Satisfaction With Medication Score [ Time Frame: Day 30, Day 90 ]
    Subject overall satisfaction with effectiveness of the therapy as measured by score on the Satisfaction with Medication questionnaire. Scale range: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied.
  • Quality of Life Scores [ Time Frame: Day 0, Day 30, Day 90 ]
    Quality of life as measured by Migraine Specific Quality of Life questionnaire (MSQ) scores. 14 questions ask how often headaches have interfered with specific daily activities in previous 4 weeks. 6-point scale ranges from "None of the time" to "All of the time".
  • Sustained Treatment Effect [ Time Frame: Day 0, Day 10, Day 30 ]
    Sustained treatment effect as measured by the MEWT Performance Index score compared to change in number of Headache Days. Results would be presented in the form of a correlation analysis. There is an expected negative correlation as performance index increases and number of headache days decrease (a correlation of -1).


Original Secondary Outcome:

  • Subject satisfaction with therapy as measured by Satisfaction with Medication questionnaire [ Time Frame: Day 30, Day 90 ]
  • Quality of life as measured by Headache Specific Quality of Life questionnaire (MSQ) [ Time Frame: Day 0, Day 30, Day 90 ]
  • Sustained treatment effect as measured by the MEWT and Headache Diary [ Time Frame: Day 0, Day 10, Day 30 ]


Information By: Cady, Roger, M.D.

Dates:
Date Received: June 14, 2007
Date Started: October 2006
Date Completion:
Last Updated: February 4, 2013
Last Verified: February 2013