Trial Outcomes & Findings for Sildenafil Treatment for Mild TBI (NCT NCT03598140)
NCT ID: NCT03598140
Last Updated: 2020-11-19
Results Overview
Prior to and after sildenafil treatment (60mg) cerebral blood flow will be measured in the athletes and healthy controls.
TERMINATED
PHASE2
22 participants
3 years
2020-11-19
Participant Flow
Participant milestones
| Measure |
Placebo Oral Capsule
If randomized to placebo, the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.
Placebo oral capsule: Placebo once (Group 1) or daily for 2 weeks (Group 2)
|
Sildenafil Citrate
If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.
Sildenafil Citrate: Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo Oral Capsule
If randomized to placebo, the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.
Placebo oral capsule: Placebo once (Group 1) or daily for 2 weeks (Group 2)
|
Sildenafil Citrate
If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.
Sildenafil Citrate: Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)
|
|---|---|---|
|
Overall Study
enrolled but didn't start
|
1
|
0
|
Baseline Characteristics
Sildenafil Treatment for Mild TBI
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 3 yearsPopulation: The PI has left the institution, all efforts to locate the data have been exhausted and therefore no results are available to be reported
Prior to and after sildenafil treatment (60mg) cerebral blood flow will be measured in the athletes and healthy controls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: The PI has left the institution, all efforts to locate the data have been exhausted and therefore no results are available to be reported
This test will measure a range of injury severities: 0= Not experienced at all 1. No more of a problem 2. A mild problem 3. A moderate problem 4. A severe problem Improvement or worsening of symptoms (headaches, nausea, fatigue, feeling depressed, light sensitivity, double vision, etc.) will be recorded. The combined score from all symptoms will be recorded at the indicated time-points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: The PI has left the institution, all efforts to locate the data have been exhausted and therefore no results are available to be reported
Using the HVLT, performance in learning and memory will be measured in concussed athletes and healthy controls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: The PI has left the institution, all efforts to locate the data have been exhausted and therefore no results are available to be reported
Before and after sildenafil treatment, cerebrovascular reactivity will be measured in the athletes and healthy controls.
Outcome measures
Outcome data not reported
Adverse Events
Placebo Oral Capsule
Sildenafil Citrate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place