Concussion
Conditions
Keywords
Concussion
Brief summary
Concussions are a common injury among athletes in the United States. The annual incidence of sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8 million, and the likelihood of an athlete in a contact sport experiencing a concussion is as high as 20 percent per season. Even mild traumatic brain injury, including concussion, can cause long-term cognitive problems that affect a person's ability to perform daily activities and to return to school or work. Far more concerning is the mounting body of evidence that concussions are not just transient injuries - but have cumulative effects. It has been well established in animal models that progesterone has neuroprotective benefits. Animal studies using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema, reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral outcomes. To date, there have been no studies to assess whether or not progesterone will be effective for the treatment of concussions. This double-blind placebo controlled trial will assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize that athletes treated with progesterone will have faster resolution of their concussive symptoms. The investigators believe this study may be the first clinical trial to show an effective treatment for concussion.
Interventions
DRUGProgesterone
DRUGPlacebo
Standard placebo
Sponsors
American Medical Society for Sports Medicine (AMSSM) Foundation
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with a concussion * A 18 years or older * Diagnosis \< 24 hours from injury * Consent obtained prior to concussion
Exclusion criteria
* Pregnant * Active breast or reproductive organ cancers * Allergy to peanuts * History of or current thrombophlebitis or venous thromboembolic disorder * Females taking birth control * Known hypersensitivity or prior adverse reaction to progesterone * Known liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (in Days) That a Patient Reports Symptoms From Their Concussion. | From date of injury until date asymptomatic, assessed up to 24 months | The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Progesterone 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five
Progesterone | 18 |
| Placebo Placebo: Standard placebo for 5 days | 7 |
| Total | 25 |
Baseline characteristics
| Characteristic | Progesterone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 7 Participants | 25 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 18 Participants | 5 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 7 |
| serious Total, serious adverse events | 0 / 18 | 0 / 7 |
Outcome results
Primary
Time (in Days) That a Patient Reports Symptoms From Their Concussion.
The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline.
Time frame: From date of injury until date asymptomatic, assessed up to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progesterone | Time (in Days) That a Patient Reports Symptoms From Their Concussion. | 7.3 Days Symptomatic | Standard Error 8.64 |
| Placebo | Time (in Days) That a Patient Reports Symptoms From Their Concussion. | 4.5 Days Symptomatic | Standard Error 1.97 |
p-value: 0.42ANOVA