Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction
Primary Purpose
Post Traumatic Headache
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naratriptan HCl
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Headache focused on measuring Post traumatic headache, Head trauma, Head injury, Headache, Naratriptan
Eligibility 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
Sites / Locations
- Clinvest
- Carolinas Rehabilitation, Carolinas HealthCare System
- Anodyne Headache and Pain Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
Naratriptan 2.5 mg tablet bid x 30 days
placebo matching naratriptan 2.5 mg tablet
Outcomes
Primary Outcome Measures
Headache Days
Number of headache days as measured by the Headache Diary
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.
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.
Secondary Outcome Measures
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.
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".
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).
Full Information
NCT ID
NCT00487578
First Posted
June 14, 2007
Last Updated
February 4, 2013
Sponsor
Cady, Roger, M.D.
Collaborators
GlaxoSmithKline, Clinvest
1. Study Identification
Unique Protocol Identification Number
NCT00487578
Brief Title
Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction
Official Title
Evaluation of the Efficacy of Naratriptan for the Treatment and Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Terminated October 2009 (in 4th year) due to low enrollment and anticipated drug expiration November 2009.
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cady, Roger, M.D.
Collaborators
GlaxoSmithKline, Clinvest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Headache
Keywords
Post traumatic headache, Head trauma, Head injury, Headache, Naratriptan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Naratriptan 2.5 mg tablet bid x 30 days
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
placebo matching naratriptan 2.5 mg tablet
Intervention Type
Drug
Intervention Name(s)
naratriptan HCl
Other Intervention Name(s)
Amerge
Intervention Description
naratriptan 2.5mg tablet bid x 30 days OR matching placebo
Primary Outcome Measure Information:
Title
Headache Days
Description
Number of headache days as measured by the Headache Diary
Time Frame
Day 30
Title
Headache Impact Test-6 (HIT-6) Score
Description
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.
Time Frame
Day 0, Day 30
Title
Mental Efficiency Workload Test (MEWT) Performance Index Score
Description
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.
Time Frame
Day 0, Day 10, Day 30
Secondary Outcome Measure Information:
Title
Overall Satisfaction With Medication Score
Description
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.
Time Frame
Day 30, Day 90
Title
Quality of Life Scores
Description
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".
Time Frame
Day 0, Day 30, Day 90
Title
Sustained Treatment Effect
Description
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).
Time Frame
Day 0, Day 10, Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger K Cady, MD
Organizational Affiliation
Clinvest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Carolinas Rehabilitation, Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Anodyne Headache and Pain Care
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15658950
Citation
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. doi: 10.1111/j.1468-2982.2004.00818.x. Erratum In: Cephalalgia. 2005 Mar;25(3):240.
Results Reference
background
PubMed Identifier
14979299
Citation
Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
Results Reference
background
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Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction
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