We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

This study has been terminated.
(Enrollment rate was slower than anticipated.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053507
First Posted: January 21, 2010
Last Update Posted: March 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cady, Roger, M.D.
Results First Submitted: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Post-Traumatic Headache
Interventions: Drug: sumatriptan/naproxen sodium
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treximet

In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.

sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Placebo

In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.

Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.


Participant Flow:   Overall Study
    Treximet   Placebo
STARTED   11   12 
COMPLETED   8   11 
NOT COMPLETED   3   1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treximet

In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.

sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Placebo

In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.

Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Total Total of all reporting groups

Baseline Measures
   Treximet   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   12   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.36  (9.83)   35.83  (12.01)   38.48  (11.14) 
Gender 
[Units: Participants]
     
Female   6   9   15 
Male   5   3   8 
Region of Enrollment 
[Units: Participants]
     
United States   11   12   23 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Headache Days   [ Time Frame: Day 0, Day +30 ]

2.  Primary:   Associated Headache Symptoms   [ Time Frame: Day 0, Day +30 ]

3.  Secondary:   Mental Efficiency Workload Test (MEWT) Performance Index   [ Time Frame: Day 0, Day +30 ]

4.  Secondary:   Headache Impact Test-6 (HIT-6) Score   [ Time Frame: Day 0, Day +30 ]

5.  Secondary:   Migraine Specific Quality of Life Questionnaire (MSQ)   [ Time Frame: Day 0, Day +30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Roger K. Cady
Organization: Clinvest/A Division of Banyan Group, Inc.
phone: 417-841-3673
e-mail: jtarrasch@clinvest.com


Publications:

Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01053507     History of Changes
Other Study ID Numbers: 114126
First Submitted: January 19, 2010
First Posted: January 21, 2010
Results First Submitted: January 28, 2014
Results First Posted: March 10, 2014
Last Update Posted: March 10, 2014