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Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT01053507
Recruitment Status : Terminated (Enrollment rate was slower than anticipated.)
First Posted : January 21, 2010
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cady, Roger, M.D.

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
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treximet Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 11 12
Completed 8 11
Not Completed 3 1
Arm/Group Title Treximet Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 23 participants
41.36  (9.83) 35.83  (12.01) 38.48  (11.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
6
  54.5%
9
  75.0%
15
  65.2%
Male
5
  45.5%
3
  25.0%
8
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 12 participants 23 participants
11 12 23
1.Primary Outcome
Title Headache Days
Hide Description Change in number of headache days at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.
Time Frame Day 0, Day +30
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.
Arm/Group Title Treximet Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Associated Headache Symptoms
Hide Description Change in number of associated headache symptoms at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.
Time Frame Day 0, Day +30
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.
Arm/Group Title Treximet Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Mental Efficiency Workload Test (MEWT) Performance Index
Hide Description [Not Specified]
Time Frame Day 0, Day +30
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.
Arm/Group Title Treximet Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Headache Impact Test-6 (HIT-6) Score
Hide Description [Not Specified]
Time Frame Day 0, Day +30
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.
Arm/Group Title Treximet Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Migraine Specific Quality of Life Questionnaire (MSQ)
Hide Description [Not Specified]
Time Frame Day 0, Day +30
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.
Arm/Group Title Treximet Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Day 0, Day +30
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treximet Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Treximet Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treximet Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treximet Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/11 (63.64%)      11/12 (91.67%)    
Cardiac disorders     
Increased Heart Rate  0/11 (0.00%)  0 1/12 (8.33%)  7
Ear and labyrinth disorders     
Ear Ache  0/11 (0.00%)  0 1/12 (8.33%)  1
Gastrointestinal disorders     
Throat Tightness  0/11 (0.00%)  0 1/12 (8.33%)  8
Nausea  2/11 (18.18%)  10 2/12 (16.67%)  4
Vomiting  0/11 (0.00%)  0 1/12 (8.33%)  1
General disorders     
Head Burning Sensation  0/11 (0.00%)  0 1/12 (8.33%)  1
Shaking  0/11 (0.00%)  0 1/12 (8.33%)  1
Dry Mouth  1/11 (9.09%)  5 0/12 (0.00%)  0
Increased Energy  1/11 (9.09%)  1 0/12 (0.00%)  0
Thirsty  2/11 (18.18%)  2 0/12 (0.00%)  0
Excessive Sweating  2/11 (18.18%)  4 0/12 (0.00%)  0
Infections and infestations     
Sinus Infection  1/11 (9.09%)  1 1/12 (8.33%)  1
Fever  0/11 (0.00%)  0 1/12 (8.33%)  1
Investigations     
Elevated Creatinine  0/11 (0.00%)  0 1/12 (8.33%)  1
Elevated ALT  1/11 (9.09%)  1 0/12 (0.00%)  0
Elevated AST  1/11 (9.09%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Chest Pressure  0/11 (0.00%)  0 1/12 (8.33%)  2
Slow Motor Function  0/11 (0.00%)  0 1/12 (8.33%)  1
Jaw Ache  0/11 (0.00%)  0 1/12 (8.33%)  1
Tooth Ache  1/11 (9.09%)  1 1/12 (8.33%)  1
Left Arm Pain  0/11 (0.00%)  0 1/12 (8.33%)  1
Left Scapula Pain  0/11 (0.00%)  0 1/12 (8.33%)  1
Left Leg Fell Asleep  0/11 (0.00%)  0 1/12 (8.33%)  1
Right Arm Tingling  0/11 (0.00%)  0 1/12 (8.33%)  1
Aching Leg Muscles  1/11 (9.09%)  1 0/12 (0.00%)  0
Sensations of Needles in Head  1/11 (9.09%)  1 0/12 (0.00%)  0
Cramping Sides  1/11 (9.09%)  2 0/12 (0.00%)  0
Calf Cramps  1/11 (9.09%)  1 0/12 (0.00%)  0
Nervous system disorders     
Dizziness  2/11 (18.18%)  3 1/12 (8.33%)  1
Drowsy  2/11 (18.18%)  2 2/12 (16.67%)  3
Temporal Bilateral Vein Throbbing  1/11 (9.09%)  6 0/12 (0.00%)  0
Light Sensitivity  1/11 (9.09%)  1 0/12 (0.00%)  0
Psychiatric disorders     
Depression  1/11 (9.09%)  1 1/12 (8.33%)  1
Moody  1/11 (9.09%)  1 0/12 (0.00%)  0
Insomnia  1/11 (9.09%)  1 0/12 (0.00%)  0
Renal and urinary disorders     
Increased Urination  1/11 (9.09%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Head Cold  1/11 (9.09%)  2 3/12 (25.00%)  3
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
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