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Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome

NCT03066193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-02-24

Study results available
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Summary

This is an investigator-initiated proof of concept study with the purpose to examine the safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the treatment of adults with Tourette syndrome.

Conditions

  • Tourette Syndrome

Interventions

DRUG

Dronabinol and Palmitoylethanolamide

Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks.

Sponsors & Collaborators

  • SciSparc

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Michael H. Bloch, MD, MS · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-06-28
Completion
2018-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03066193 on ClinicalTrials.gov