Expanded Access Program for Treatment With Ecopipam for Tourette's Disorder
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age6-50
SponsorEmalex Biosciences Inc.
About this trial
The goal of this expanded access study is to learn about the long-term effects of Ecopipam in participants with Tourette's Disorder (TD). The main question it aims to answer is:
* Is ecopipam safe and well-tolerated in participants equal and over the age of 6 to 50 with TD? * Assess quality of life measures and to provide access to ecopipam while NDA is being prepared and submitted for review for marketing approval
Eligible participants with TD will take ecopipam with guidance from their treating physician. In addition to the standard of care from the treating physician, treatment with ecopipam will continue until ecopipam becomes commercially available in the United States or the program is terminated.
While in the EAP program, participants will be asked regarding how safe and tolerable ecopipam is to the participant. Several questionnaires will be collected regarding participants experiences while taking ecopipam during monthly visits for the first year and every three months thereafter until the conclusion of the study.
Eligibility criteria
Qualifiers
Age 6 to 50 years old inclusive at the time of informed consent/assent.
Participant must sign/date the most current Informed Consent Form (ICF). For minor participants the LAR must/sign date the most current consent and the participant must sign/date the most current age-appropriate assent.
In the opinion of the principal investigator (PI), the participant or in the case of a minor their LAR is capable of understanding and complying with protocol and program requirements, oral drug administration and care instructions.
Weight ≥18 kg (39.6 lbs.).
Disqualifiers
None
Trial design
Treatments tested in this trial
- ecopipam HCl ~2mg/kg/day
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov