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

NCT03242928 | Completed Phase 2 Results

• 2 other identifiers: CAFQ056X22012017-000736-33
• Study Type: interventional
• Target: 68
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

Cocaine-related Disorder

Keywords

Cocaine Use Disorder; cocaine dependence,AFQ056,adult, cocaine use,CUD, drug abuse, drug addiction,

Outcome Measures

Primary Outcomes (1)

• Proportion of Cocaine Use Days

  The cocaine consumption was recorded once daily (Yes/No) by the subject using the Timeline Follow-Back (TLFB) cocaine assessment tool during the treatment period. For each patient, the proportion of cocaine use days was calculated by dividing the number of days of cocaine use during the treatment period, i.e. 98 days for completers and number of days between Day 1 and day of last dose in case of premature discontinuation of study treatment.

  Day 1 up to day 98

Secondary Outcomes (3)

• Proportion of Positive Urine Measurements of Benzoylecgonine (BE)

  Day 1 up to day 98

• Proportion of Days of Alcohol Consumption

  Day 1 up to day 98

• AFQ056 Plasma Concentrations

  Day 15 (0h, 2h), Day 29 (0, 2h), Day 57 (0h, 2h), Day 98 (0h,2h)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching tablet of placebo taken orally BID

Drug: Placebo

AFQ056

EXPERIMENTAL

Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days

Drug: AFQ056

Interventions

AFQ056 DRUG

50 mg and 100 mg tablets taken orally

Also known as: mavoglurant

AFQ056

Placebo DRUG

Matching placebo tablets taken orally BID

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the study procedures and provide written informed consent before any assessment is performed.
• Subjects diagnosed with Cocaine Use Disorder according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Ed.).
• Must use cocaine through snorting (intranasally) as primary route of administration.
• Recent cocaine use confirmed by positive urine screen for 1 or more benzoylecgonine (BE).
• Must be seeking treatment for cocaine dependence and have a desire to reduce or cease cocaine use.

You may not qualify if:

• Has current diagnosis of Substance Use Disorder (according to the DSM 5) on alcohol, cannabis or other stimulants, except cocaine.
• Meets current or lifetime DSM 5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
• Have current treatment for Substance Use Disorder (e.g.: disulfiram, acamprosate, methyl phenidate, modafinil, topiramate, immediate release dexamfetamine,or baclofen).
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
• Have a history of any illness, condition, and use of medications that in the opinion of the investigator or designee might confound the results of the study or pose additional risk in administering the investigational agents to the subject or preclude successful completion of the study
• Current or/and previous treatment with concomitant medications that are strong or moderate inducers/inhibitors of CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, etc.)
• History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
• Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
• Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the CSSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
• Controlled hypertension

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Buenos Aires, 1058, Argentina

Location

Novartis Investigative Site

Buenos Aires, 4634, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1405B0A, Argentina

Location

Novartis Investigative Site

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

Novartis Investigative Site

Basel, 4025, Switzerland

Location

Novartis Investigative Site

Zurich, 8001, Switzerland

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

mavoglurant

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharma AG

Novartis.email@Novartis.com

613241111

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 8, 2017
• Study Start: December 4, 2017
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: October 8, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-10

Locations

AR (3); ES (3); CH (2)