NCT03087201

CANNAbinoids in the Treatment of TICS (CANNA-TICS)

A Randomized Multi-centre Double-blind Placebo Controlled Trial to Demonstrate the Efficacy and Safety of Nabiximols in the Treatment of Adults With Chronic Tic Disorders

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-04-05
• Primary completion: 2020-11-20
• Completion: 2020-11-20
• First posted: 2017-03-22
• Last updated: 2020-12-10

Locations

6 sites across 1 country: Germany