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

Post Traumatic Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00487578
• Other study ID #: 106542
• Status: Terminated
• Phase: Phase 4
• First received: June 14, 2007
• Last updated: February 4, 2013
• Start date: October 2006
• Est. completion date: October 2009

Study information

• Verified date: February 2013
• Source: Cady, Roger, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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 medication, and quality of life. Cognition will be measured using the MEWT.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Males and females between the ages of 18-55. A female is eligible to enter and participate if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following: Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval (5 days) after completion or premature discontinuation from the study; subjects utilizing this method must agree to use alternate method of contraception if they become sexually active and will be queried on whether they have been abstinent when they present to the clinic for the Final Visit or, Female sterilization; or, Sterilization of male partner; or, Implants of levonorgestrel; or, Injectable progestogen; or, Oral contraceptive (combined or progestogen only); or, Any intrauterine device (IUD) with published data showing highest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or, Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm). Any other barrier methods (only if used in combination with any of the above acceptable methods) or, Any other methods with published data showing highest expected failure rate for that method is less than 1% per year.

• Formally diagnosed ICHD 5.2.2 chronic post traumatic headache

• Have had traumatic brain injury (TBI) not more than 5 years prior to enrollment

• Medically stable as determined by Investigator

• On stabilized dosage of any headache preventive medications for 3 months prior to screening

• On stabilized dosage of concomitant medications at discretion of investigator

• Chronic headache history only after the TBI

• Able to understand and communicate intelligibly with study observer

• Able to take oral medication, adhere to the medication regimens and perform study procedures

• Able to read and comprehend written instructions and be willing to complete all procedures and assessments required by protocol

• Subject is able to demonstrate willingness to participate by signing and understanding an informed consent after full explanation of study

• Self-reported cognitive inefficiency or "brain-fog" during headache

Exclusion Criteria:

• History of hypersensitivity to triptan-like medication

• Pathology of salivary glands such as sialadenitis (e.g., Sjorgen's Syndrome, viral or bacterial sialadenitis, or obstructive sialadenitis)

• Any condition or symptom that would knowingly alter content of saliva

• History of, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes or other significant underlying cardiovascular disease. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g. stable angina of effort and vasospastic forms of angina such as Prinzmetal variant, all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease.

• Any medication overuse that in the opinion of the investigator has exacerbated or contributed to current headache pattern of subject

• Uncontrolled hypertension, severe renal impairment, severe hepatic impairment, hemiplegic or basilar headache

• History of hypersensitivity to naratriptan or any components

• Pregnant, trying to get pregnant, or lactating

• Recent history of abuse of alcohol or other drugs that would interfere with participation

• Participation in another investigative drug study within previous 30 days

• Chronic pain syndromes, fibromyalgia, Gulf War Syndrome, and other multisystem diseases characterized by poor or no response to pain-reducing interventions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Headache
• Post Traumatic Headache
• Post-Traumatic Headache

Intervention

Drug:
• naratriptan HCl
naratriptan 2.5mg tablet bid x 30 days OR matching placebo

Locations

Country	Name	City	State
United States	Carolinas Rehabilitation, Carolinas HealthCare System	Charlotte	North Carolina
United States	Anodyne Headache and Pain Care	Dallas	Texas
United States	Clinvest	Springfield	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Cady, Roger, M.D.	Clinvest, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (2)

Baandrup L, Jensen R. Chronic post-traumatic headache--a clinical analysis in relation to the International Headache Classification 2nd Edition. Cephalalgia. 2005 Feb;25(2):132-8. Erratum in: Cephalalgia. 2005 Mar;25(3):240. — View Citation

Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Days	Number of headache days as measured by the Headache Diary	Day 30	No
Primary	Headache Impact Test-6 (HIT-6) Score	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.	Day 0, Day 30	No
Primary	Mental Efficiency Workload Test (MEWT) Performance Index Score	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.	Day 0, Day 10, Day 30	No
Secondary	Overall Satisfaction With Medication Score	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.	Day 30, Day 90	No
Secondary	Quality of Life Scores	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".	Day 0, Day 30, Day 90	No
Secondary	Sustained Treatment Effect	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).	Day 0, Day 10, Day 30	No