Emalex Expanded Access Program for Children, Adolescents, and Adults with Tourette’s Syndrome

Emalex Expanded Access Program for Children, Adolescents, and Adults with Tourette’s Syndrome

Study directors: Kevin Shapiro, MD PhD, and Elysa Marco, MD

Recruiting: Yes

Study Title: An Open Label Expanded Access Program Intended to Provide Treatment with Ecopipam (EBS-101) to Children, Adolescents, and Adults in the U.S. with Tourette’s Syndrome

Condition: Tourette’s Syndrome

Purpose: "Compassionate Use" (also known as Expanded Access) is a pathway for patients with a serious condition to gain access to an investigational medical product for treatment outside of traditional clinical trials when no comparable or satisfactory alternative therapy options are available. The primary goal is to provide Ecopipam to patients while the drug moves toward formal FDA approval. There is no "placebo." All participants in this program receive the active medication.

Eligibility

Inclusion criteria:

• 6-50 years old

• Diagnosed (or suspected) Tourette’s Syndrome

• Moderate-to-severe motor and vocal tics

• You have previously tried an FDA-approved medication for TD (like aripiprazole or haloperidol) that was not effective, caused side effects, or you did not have access to these medication options.

Exclusion criteria:

• Unstable medical or psychiatric illness

• Current use of other medications – contact our study team to discuss

What is Involved?

• Visits: The program includes an initial screening, followed by monthly visits for the first year, and visits every 3–6 months thereafter.

• Duration: Participants may stay in the program until the drug becomes commercially available.

• Costs: No costs will be charged for any of the study procedures

• Payment: As this is not a traditional clinical trial, subjects will not be paid for their participation.

Location and Contact Information

• Location: Cortica Marin and Cortica Glendale

• Coordinator: Kelly Olvany – kolvany@corticacare.com – (331) 272-1322

• Fill out our Interest Form and we will contact you!