NCT03242928

Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)

A Randomized, Subject and Investigator Blinded, Placebo-controlled, Parallel Group Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study assessed whether AFQ056 had a beneficial effect by reducing cocaine use in Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.

Detailed description

This was a randomized, subject- and Investigator-blinded, parallel-group, placebo-controlled study in subjects with CUD. The study consisted of a 17-day screening period followed by a 12-day baseline, a 98-day outpatient treatment period (14-day up-titration dose regimen followed by 84-day maintenance dose), and an End of Study evaluation visit approximately 14 days after the last study drug administration. The total duration for each subject in the study was approximately 20 weeks including screening and baseline.

Conditions

• Cocaine-related Disorder

Interventions

Type	Name	Description
DRUG	AFQ056	50 mg and 100 mg tablets taken orally
DRUG	Placebo	Matching placebo tablets taken orally BID

Timeline

• Start date: 2017-12-04
• Primary completion: 2019-12-16
• Completion: 2019-12-16
• First posted: 2017-08-08
• Last updated: 2021-10-08
• Results posted: 2021-02-04

Locations

8 sites across 3 countries: Argentina, Spain, Switzerland