Trial Outcomes & Findings for Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction (NCT NCT01053507)
NCT ID: NCT01053507
Last Updated: 2020-07-29
Results Overview
Change in number of headache days at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
Day 0, Day 30
Results posted on
2020-07-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
Baseline characteristics by cohort
| Measure |
Treximet
n=11 Participants
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
n=12 Participants
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
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.36 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
35.83 years
STANDARD_DEVIATION 12.01 • n=7 Participants
|
38.48 years
STANDARD_DEVIATION 11.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 30Population: Analysis population only includes subjects that provided data at both time points (Day 0 and Day 30).
Change in number of headache days at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm.
Outcome measures
| Measure |
Treximet
n=7 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Headache Days
|
-3.00 days
Standard Deviation 7.6
|
-0.30 days
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Day 0, Day 30Population: Analysis population only includes subjects that provided data at both time points (Day 0 and Day 30).
Change in number of associated headache symptoms at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm. Associated headache symptoms measured included number of incidences of: sleeplessness, difficulty thinking, and bodily pain.
Outcome measures
| Measure |
Treximet
n=7 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Change in Number of Associated Headache Symptoms
Change in Sleeplessness
|
2.43 change in number of symptoms
Standard Deviation 7.76
|
-2.30 change in number of symptoms
Standard Deviation 3.47
|
|
Change in Number of Associated Headache Symptoms
Change in Difficulty Thinking
|
0.14 change in number of symptoms
Standard Deviation 12.32
|
0.00 change in number of symptoms
Standard Deviation 4.83
|
|
Change in Number of Associated Headache Symptoms
Change in Bodily Pain
|
-1.71 change in number of symptoms
Standard Deviation 6.52
|
-3.80 change in number of symptoms
Standard Deviation 5.67
|
SECONDARY outcome
Timeframe: Day 0, Day 30Population: Analysis population only includes subjects that provided data at both time points (Day 0 and Day 30).
The Mental Efficiency Workload Test (MEWT) performance index is a scale with minimum and maximum values of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning.
Outcome measures
| Measure |
Treximet
n=6 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
Mental Efficiency Workload Test (MEWT) Performance Index
Day 30
|
3.17 units on a scale
Standard Deviation 2.23
|
3.11 units on a scale
Standard Deviation 2.09
|
|
Mental Efficiency Workload Test (MEWT) Performance Index
Day 0
|
3.10 units on a scale
Standard Deviation 2.28
|
3.4 units on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: Day 0, Day 30Population: Analysis population only includes subjects that provided data at both time points (Day 0 and Day 30).
The Headache Impact Test-6 (HIT-6) scale measures the impact of headache symptoms on subject's life. 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.
Outcome measures
| Measure |
Treximet
n=7 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Headache Impact Test-6 (HIT-6) Score
Day 0
|
59.43 units on a scale
Standard Deviation 6.65
|
61.91 units on a scale
Standard Deviation 3.21
|
|
Headache Impact Test-6 (HIT-6) Score
Day 30
|
58.57 units on a scale
Standard Deviation 6.13
|
61.91 units on a scale
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Day 0, Day 30Population: Analysis population only includes subjects that provided data at both time points (Day 0 and Day 30).
The Migraine-Specific Quality of Life Questionnaire (MSQ) is a scale that measures the impact of migraine across three aspects: role function-restrictive (RR), role function-preventive (RP), and emotional function (EF). Possible scores on each subscale range from a 0 to 100 scale such that higher scores indicate better quality of life.
Outcome measures
| Measure |
Treximet
n=7 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Migraine Specific Quality of Life Questionnaire (MSQ)
Day 30 - Role Function-Preventive Score
|
80 units on a scale
Standard Deviation 13.84
|
69.55 units on a scale
Standard Deviation 24.95
|
|
Migraine Specific Quality of Life Questionnaire (MSQ)
Day 0 - Role Function-Restrictive Score
|
60 units on a scale
Standard Deviation 12.34
|
45.71 units on a scale
Standard Deviation 16.95
|
|
Migraine Specific Quality of Life Questionnaire (MSQ)
Day 30 - Role Function-Restrictive Score
|
59.59 units on a scale
Standard Deviation 23.81
|
50.39 units on a scale
Standard Deviation 19.35
|
|
Migraine Specific Quality of Life Questionnaire (MSQ)
Day 0 - Role Function-Preventive Score
|
79.29 units on a scale
Standard Deviation 14.84
|
68.64 units on a scale
Standard Deviation 22.81
|
|
Migraine Specific Quality of Life Questionnaire (MSQ)
Day 0 - Emotional Function Score
|
60 units on a scale
Standard Deviation 18.05
|
50.91 units on a scale
Standard Deviation 25.69
|
|
Migraine Specific Quality of Life Questionnaire (MSQ)
Day 30 - Emotional Function Score
|
65.03 units on a scale
Standard Deviation 28.76
|
57.58 units on a scale
Standard Deviation 29.25
|
Adverse Events
Treximet
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treximet
n=11 participants at risk
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
n=12 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Throat Tightness
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 8 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Chest Pressure
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 2 • Day 0, Day +30
|
|
Cardiac disorders
Increased Heart Rate
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 7 • Day 0, Day +30
|
|
Investigations
Elevated Creatinine
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 10 • Day 0, Day +30
|
16.7%
2/12 • Number of events 4 • Day 0, Day +30
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • Number of events 3 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Infections and infestations
Sinus Infection
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Infections and infestations
Fever
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Slow Motor Function
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Nervous system disorders
Drowsy
|
18.2%
2/11 • Number of events 2 • Day 0, Day +30
|
16.7%
2/12 • Number of events 3 • Day 0, Day +30
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
General disorders
Head Burning Sensation
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Ear and labyrinth disorders
Ear Ache
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Jaw Ache
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Tooth Ache
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Respiratory, thoracic and mediastinal disorders
Head Cold
|
9.1%
1/11 • Number of events 2 • Day 0, Day +30
|
25.0%
3/12 • Number of events 3 • Day 0, Day +30
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
General disorders
Shaking
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Left Arm Pain
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Left Scapula Pain
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Left Leg Fell Asleep
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Right Arm Tingling
|
0.00%
0/11 • Day 0, Day +30
|
8.3%
1/12 • Number of events 1 • Day 0, Day +30
|
|
General disorders
Dry Mouth
|
9.1%
1/11 • Number of events 5 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Nervous system disorders
Temporal Bilateral Vein Throbbing
|
9.1%
1/11 • Number of events 6 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
General disorders
Increased Energy
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Investigations
Elevated ALT
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Investigations
Elevated AST
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
General disorders
Thirsty
|
18.2%
2/11 • Number of events 2 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
General disorders
Excessive Sweating
|
18.2%
2/11 • Number of events 4 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Aching Leg Muscles
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Renal and urinary disorders
Increased Urination
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Sensations of Needles in Head
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Cramping Sides
|
9.1%
1/11 • Number of events 2 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Psychiatric disorders
Moody
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Musculoskeletal and connective tissue disorders
Calf Cramps
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
|
Nervous system disorders
Light Sensitivity
|
9.1%
1/11 • Number of events 1 • Day 0, Day +30
|
0.00%
0/12 • Day 0, Day +30
|
Additional Information
Dr. Roger K. Cady
Clinvest/A Division of Banyan Group, Inc.
Phone: 417-841-3673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place