Trial Outcomes & Findings for Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction (NCT NCT00487578)
NCT ID: NCT00487578
Last Updated: 2013-02-11
Results Overview
Number of headache days as measured by the Headache Diary
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
Day 30
Results posted on
2013-02-11
Participant Flow
Subject enrollment started in 2006 at Site 1 (headache specialty clinic). Subjects were never enrolled at 2nd site (hospital rehabilitation center). Sites 3 (pain clinic) and 4 (hospital rehabilitation center) were added in 2008. Enrollment continued until study termination October 2009.
19 participants were screened. 7 were Screen Failures.
Participant milestones
| Measure |
Active Naratriptan
Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
|
Placebo Matching Naratriptan
placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Active Naratriptan
Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
|
Placebo Matching Naratriptan
placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction
Baseline characteristics by cohort
| Measure |
Active Naratriptan
n=3 Participants
Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
|
Placebo Matching Naratriptan
n=9 Participants
placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
39.66 years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
37.22 years
STANDARD_DEVIATION 9.65 • n=7 Participants
|
37.83 years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.
Number of headache days as measured by the Headache Diary
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 0, Day 30Population: No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 0, Day 10, Day 30Population: No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 30, Day 90Population: No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, Day 30, Day 90Population: No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, Day 10, Day 30Population: No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.
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).
Outcome measures
Outcome data not reported
Adverse Events
Active Naratriptan
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Matching Naratriptan
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Naratriptan
n=3 participants at risk
Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
|
Placebo Matching Naratriptan
n=9 participants at risk
placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
100.0%
3/3 • Number of events 3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
22.2%
2/9 • Number of events 2 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Musculoskeletal and connective tissue disorders
low back pain
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 2 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Fatigue
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
22.2%
2/9 • Number of events 2 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Renal and urinary disorders
Drowsiness
|
33.3%
1/3 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
0.00%
0/9 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Gastrointestinal disorders
Reflux
|
33.3%
1/3 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
0.00%
0/9 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Skin and subcutaneous tissue disorders
Tingling
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 2 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Nervous system disorders
Increased headache severity
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
22.2%
2/9 • Number of events 2 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Dry mouth
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Nervous system disorders
Change in headache location
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Nervous system disorders
Change in headache sensation
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Musculoskeletal and connective tissue disorders
Achiness
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Chest pain
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 2 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Stomach tenderness
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Twitching eye
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Increased twitching left arm
|
33.3%
1/3 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
0.00%
0/9 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Nervous system disorders
Increased headache frequency
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Sweating
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Skin and subcutaneous tissue disorders
Itching neck
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Itching eyes
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Vascular disorders
Redness of face
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Feels hot and cold
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Chills
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
0.00%
0/9 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
|
General disorders
Unbalanced gait
|
0.00%
0/3 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
11.1%
1/9 • Number of events 1 • 90 days
AEs collected from Diaries reviewed at Visit 2/Day 10 and Visit 3/Day 30. AEs collected during phone interviews (Days 5, 15, 21, 32, and 90).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study data collected by Investigator is authorized subject to the following:Investigator is free to publish results of its part of study in collaboration with other investigators subsequent to the multicenter publication issued by Clinvest. If no multicenter publication is submitted within 12 months of end of study, investigator may publish results of its data. Investigator shall submit a copy of manuscript or abstract to Clinvest for review 30 days prior to journal submission.
- Publication restrictions are in place
Restriction type: OTHER