Sildenafil Treatment for Mild TBI
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03598140|
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vascular System Injuries Concussion, Brain Post-Concussion Syndrome||Drug: Sildenafil Citrate Drug: Placebo oral capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is a placebo-controlled, double-blinded clinical trial. Randomization will be 1:1 sildenafil:placebo, and will be in blocks of 10. In this study, 100 boxers and 80 controls will be enrolled and randomized.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Investigators associated with this study will not have access to the randomization schedule. The principal investigator, study team, and study subjects will be blinded in this study.|
|Official Title:||Sildenafil Treatment for Traumatic Vascular Injury in Athletes|
|Actual Study Start Date :||July 25, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Placebo Comparator: 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.
Drug: Placebo oral capsule
Placebo once (Group 1) or daily for 2 weeks (Group 2)
Other Name: Placebo
Active Comparator: 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.
Drug: Sildenafil Citrate
Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)
Other Name: Viagra
- Arterial Spin Labeling [ Time Frame: 3 years ]Prior to and after sildenafil treatment (60mg) cerebral blood flow will be measured in the athletes and healthy controls.
- Rivermead Post Concussion Symptoms Questionnaire (RPQ) [ Time Frame: 3 years ]
This test will measure a range of injury severities:
0= Not experienced at all
- No more of a problem
- A mild problem
- A moderate problem
- 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.
- Hopkins Verbal Learning Task (HVLT) [ Time Frame: 3 years ]Using the HVLT, performance in learning and memory will be measured in concussed athletes and healthy controls.
- BOLD MRI with hypercapnia [ Time Frame: 3 years ]Before and after sildenafil treatment, cerebrovascular reactivity will be measured in the athletes and healthy controls.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598140
|Contact: Joshua Gatson, PhD||214-648-0499 ext firstname.lastname@example.org|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Joshua W. Gatson, Ph.D. 214-648-0499 ext 80499 email@example.com|