Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction - Full Text View

Sponsor:	Cady, Roger, M.D.
Collaborators:	GlaxoSmithKline Clinvest
Information provided by:	Cady, Roger, M.D.
ClinicalTrials.gov Identifier:	NCT00487578

Purpose

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.

Condition	Intervention	Phase
Post Traumatic Headache	Drug: naratriptan HCl	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Evaluation of the Efficacy of Naratriptan for the Treatment and Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Naratriptan Naratriptan hydrochloride

U.S. FDA Resources

Further study details as provided by Cady, Roger, M.D.:

Primary Outcome Measures:

Headache Days [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Number of headache days as measured by the Headache Diary
Headache Impact Test-6 (HIT-6) Score [ Time Frame: Day 0, Day 30 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Overall Satisfaction With Medication Score [ Time Frame: Day 30, Day 90 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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).

Enrollment:	12
Study Start Date:	October 2006
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Naratriptan 2.5 mg tablet bid x 30 days	Drug: naratriptan HCl naratriptan 2.5mg tablet bid x 30 days OR matching placebo Other Name: Amerge
Placebo Comparator: B placebo matching naratriptan 2.5 mg tablet	Drug: naratriptan HCl naratriptan 2.5mg tablet bid x 30 days OR matching placebo Other Name: Amerge

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487578

Locations

United States, Missouri
Clinvest
Springfield, Missouri, United States, 65807
United States, North Carolina
Carolinas Rehabilitation, Carolinas HealthCare System
Charlotte, North Carolina, United States, 28203
United States, Texas
Anodyne Headache and Pain Care
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Cady, Roger, M.D.

GlaxoSmithKline

Clinvest

Investigators

Principal Investigator:

Roger K Cady, MD

Clinvest

More Information

Publications:

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.

Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. No abstract available.

Responsible Party:	Cady, Roger, M.D./CEO, Clinvest
ClinicalTrials.gov Identifier:	NCT00487578 History of Changes
Other Study ID Numbers:	106542
Study First Received:	June 14, 2007
Results First Received:	November 16, 2009
Last Updated:	January 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cady, Roger, M.D.:

Post traumatic headache
Head trauma
Head injury
Headache
Naratriptan

Additional relevant MeSH terms:

Headache
Post-Traumatic Headache
Cognition Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders
Naratriptan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012