Clinical Connection

Has Traumatic Brain Injury changed what’s inside of you or a loved one?

If you or someone you care about has experienced a traumatic brain injury (TBI) and is showing symptoms of aggression, agitation, and irritability, learn more about this research study of an investigational drug for behavioral problems due to TBI.

Trial ID: NCT03095066 MLR-786-US-0661-0221

Pharmaceutical companies use research studies like this one to collect information about investigational drugs. Using what they learn from research studies, regulatory authorities can determine if investigational drugs could one day be made available to the public. In order to conduct research studies, doctors need volunteers to participate in these studies. By participating in this study, you or someone you care about could help doctors find a more effective way to treat behavioral problems due to TBI in the future.

Trial Details

Why is this study being conducted?

Currently, there are no approved treatment options for behavioral problems that occur after a TBI. As a result, many TBI patients are unable to manage the daily negative effects the injury can have on their behavior.

In this study, doctors are evaluating the safety and effectiveness of an oral investigational drug. They want to determine what effect it has on behavioral problems that result from TBI. The investigational drug will be compared to placebo, which looks like the investigational drug but contains no active medication. The results of this study will provide doctors with more information about the investigational drug and whether it could one day be used to help manage behavioral problems caused by TBI.

Estimated Enrollment

150 Participants

Phase

2

Eligibility Criteria

Participants must:

To pre-qualify for this study, participants must:

  • Be between 18 and 75 years old
  • Have been diagnosed with TBI for 6 months or more
  • Have a history of aggression, agitation, or irritability that was not present before the injury
  • Have a reliable study partner who interacts with the participant at least 2 hours a day for at least 3 days a week
Participants must not:

Additional criteria will be assessed by the study doctor.

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What's Involved:

  • Eligible participants who agree to participate will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. Participants have a 50% chance of being assigned to receive either study drug (investigational or placebo). Participants, study partners, the study doctor, and the study staff will not know the study drug assignments. However, in the event of an emergency, this information can be provided.

  • Participants will take their assigned study drug once in the morning and once in the evening for 12 weeks. Total study participation will last approximately 17 weeks, which includes six visits to the study center and two phone calls from the study staff.

  • Participants who are currently taking medication to treat TBI may be allowed to take it throughout this study. Additionally, if allowed by the study doctor, participants could receive oral lorazepam as rescue medication.

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Actively Recruiting

  • Springfield, Massachusetts, United States
  • Denver, Colorado, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Scottsdale, Arizona, United States
  • Middleburg Heights, Ohio, United States
  • Honolulu, Hawaii , United States
  • Jupiter , Florida, United States
  • Ozark, Missouri, United States
  • Tampa, Florida, United States
  • Charlotte, North Carolina, United States
  • Canton, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Costa Mesa, California, United States
  • Lomita, California, United States
  • Coral Springs, Florida, United States
  • Doral, Florida, United States

Currently Inactive

  • (On hold) Salem, Virginia, United States
  • (Awaiting confirmation) New York, New York, United States
  • (Awaiting confirmation) Salisbury, North Carolina, United States
  • (Awaiting confirmation) San Antonio, Texas, United States
  • (Awaiting confirmation) Long Beach, California, United States
  • (Awaiting confirmation) Tuscaloosa, Alabama , United States
  • (Awaiting confirmation) Lexington, Kentucky , United States
  • (Awaiting confirmation) Richmond, Virginia , United States
  • (Awaiting confirmation) Seattle, Washington, United States
  • (Awaiting confirmation) Bradenton, Florida, United States
  • (On hold) Dallas, Texas, United States

Frequently Asked Questions (FAQs)

Check Eligibility

We’ll check to see if you are eligible by asking you some questions.

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