Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction
Information source: Cady, Roger, M.D.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Traumatic Headache
Intervention: naratriptan HCl (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Cady, Roger, M.D. Official(s) and/or principal investigator(s): Roger K Cady, MD, Principal Investigator, Affiliation: Clinvest
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.
Clinical Details
Official title: Evaluation of the Efficacy of Naratriptan for the Treatment and Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Headache DaysHeadache Impact Test-6 (HIT-6) Score Mental Efficiency Workload Test (MEWT) Performance Index Score
Secondary outcome: Overall Satisfaction With Medication ScoreQuality of Life Scores Sustained Treatment Effect
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Clinvest, Springfield, Missouri 65807, United States
Carolinas Rehabilitation, Carolinas HealthCare System, Charlotte, North Carolina 28203, United States
Anodyne Headache and Pain Care, Dallas, Texas 75231, United States
Additional Information
Related 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.
Starting date: October 2006
Last updated: February 4, 2013
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