Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

NCT01809639 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00021983
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion

Keywords

Concussion

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of injury until date asymptomatic, assessed up to 24 months

Study Arms (2)

Progesterone

EXPERIMENTAL

400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five

Drug: Progesterone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Progesterone DRUG

Also known as: Prometrium

Progesterone

Placebo DRUG

Standard placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with a concussion
• A 18 years or older
• Diagnosis \< 24 hours from injury
• Consent obtained prior to concussion

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• American Medical Society for Sports Medicine (AMSSM) Foundation: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: John Lucas
• Organization: Spartanburg Regional Healthcare System

jlucas@srhs.com

423-309-5646

Study Officials

• Christopher M Miles, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• John A Lucas, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 13, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 28, 2018
• Results First Posted: July 14, 2016

Record last verified: 2018-07

Locations

US (1)