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The EBS-101-TD-392 clinical trial is an open label expanded access program intended to provide treatment with Ecopipam to children, adolescents and adults in the U.S. with Tourette's Disorder.
What to expect from the EBS-101-TD-392 clinical trial:
How long will I be in this clinical trial?
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2 years
How often will I visit the trial site?
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1st year will be monthly visits
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Every three months for the remainder of the study
Who can be in the study?
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Anyone from 6-50 years of age
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at least 40 lbs
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Must have been treated with an FDA-approved treatment for TD or any other D2 antagonist, and have experienced treatment failure, tolerability, or saftey issues as per participant.
What are the Side Effects?
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Drowsiness
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Anxiety
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Headaches
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Insomnia
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Fatigue
Clinical trials in Tourette's Syndrome patients have shown that unlike many traditional antipsychitcs, Ecopipam does not cause weight gain, metabloic issues or drug-induced movement disorders like Tardive-Dyskinesia.
EBS-101-TD-392
Study
What will happen during the trial?
Participants in this trial will receive either the study treatment. The study treatment wil be provided as tablets to be taken orally each night. At the beginning of the treatment, the dose will be graduallyincreased towards a maximum level to see what doses may or may not work, based on weight.