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

NCT00487578 | Terminated Phase 4 Results DMC

• 1 other identifier: 106542
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Post Traumatic Headache

Keywords

Post traumatic headache; Head trauma; Head injury; Headache; Naratriptan

Outcome Measures

Primary Outcomes (3)

• Headache Days

  Number of headache days as measured by the Headache Diary

  Day 30

• 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

• 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

Secondary Outcomes (3)

• Overall Satisfaction With Medication Score

  Day 30, Day 90

• Quality of Life Scores

  Day 0, Day 30, Day 90

• Sustained Treatment Effect

  Day 0, Day 10, Day 30

Study Arms (2)

A

ACTIVE COMPARATOR

Naratriptan 2.5 mg tablet bid x 30 days

Drug: naratriptan HCl

B

PLACEBO COMPARATOR

placebo matching naratriptan 2.5 mg tablet

Drug: naratriptan HCl

Interventions

naratriptan HCl DRUG

naratriptan 2.5mg tablet bid x 30 days OR matching placebo

Also known as: Amerge

A; B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cady, Roger, M.D.: lead
• GlaxoSmithKline: collaborator
• Clinvest: collaborator

Study Sites (3)

Clinvest

Springfield, Missouri, 65807, United States

Location

Carolinas Rehabilitation, Carolinas HealthCare System

Charlotte, North Carolina, 28203, United States

Location

Anodyne Headache and Pain Care

Dallas, Texas, 75231, United States

Location

Related 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. doi: 10.1111/j.1468-2982.2004.00818.x.

  PMID: 15658950 BACKGROUND

• 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.

  PMID: 14979299 BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache; Craniocerebral Trauma; Headache

Interventions

naratriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study terminated October 2009 (in 4th year) due to low enrollment and anticipated drug expiration November 2009 (study drug had previously been re-supplied at expiration of 1st batch November 2007). No analysis performed.

Results Point of Contact

• Title: M.E. Beach
• Organization: Clinvest

mbeach@clinvest.com

(417) 841-3618

Study Officials

• Roger K Cady, MD

  Clinvest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 18, 2007
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 11, 2013
• Results First Posted: February 2, 2010

Record last verified: 2013-02

Locations

US (3)