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CANNAbinoids in the Treatment of TICS (CANNA-TICS)

NCT03087201 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2020-12-10

No results posted yet for this study

Summary

This is a multicentre, randomized, double-blind, placebo controlled, parallel-group, phase IIIb trial.

Patients (≥18 years) with chronic tic disorders and Tourette syndrome will be recruited.

The objective of the trial is to demonstrate that treatment with the cannabis extract nabiximols is superior to placebo in reducing tics and comorbidities in patients with Tourette syndrome and chronic tic disorders.

Conditions

  • Tourette Syndrome
  • Tic Disorders

Interventions

DRUG

nabiximols

starting dose (1 puff): 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD), maximum dose (12 puffs): 32.4 mg THC/30 mg CBD, no target dose is defined Duration of treatment: 13 weeks

DRUG

placebo

analogous to experimental intervention

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Kirsten Müller-Vahl, MD · Hannover Medical School, Clinic of Psychiatry, Socialpsychiatry and Psychotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2020-11-20
Completion
2020-11-20

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 NCT03087201 on ClinicalTrials.gov