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A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome

NCT03651726 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-29

No results posted yet for this study

Summary

This study evaluates the efficacy and safety of THX-110 in the management of tics and other symptoms (e.g. rage attacks, anxiety, depression, sleep difficulties) in patients with Tourette syndrome. In the first part of the study, half of the patients will receive THX-110, while the other half will receive a placebo. After completion of the first study part, patients will have the opportunity to continue into the second part of the study. In this part, all participants will receive THX-110.

Conditions

  • Tourette Syndrome

Interventions

DRUG

THX-110 (dronabinol plus PEA)

2.5 mg dronabinol capsules and 400 mg PEA tablets

DRUG

Placebo

Sesame oil pill manufactured to mimic 2.5 mg dronabinol capsules; cellulose pill manufactured to mimic 400 mg PEA tablets

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • SciSparc

    lead INDUSTRY

Principal Investigators

  • Kirsten Müller-Vahl, Prof. Dr. · Medizinische Hochschule Hannover, Klinik für Psychiatrie, Sozialpsychiatrie und Psychotherapie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2019-11-30
Completion
2019-11-30
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT03651726 on ClinicalTrials.gov