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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242928
Recruitment Status : Completed
First Posted : August 8, 2017
Results First Posted : February 4, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine-related Disorder Drug: AFQ056 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : December 16, 2019
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Matching tablet of placebo taken orally BID
 Drug: Placebo
Matching placebo tablets taken orally BID
Experimental: AFQ056
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
50 mg and 100 mg tablets taken orally
Other Name: mavoglurant


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Cocaine Use Days [ Time Frame: Day 1 up to day 98 ]
    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.


Secondary Outcome Measures :
  1. Proportion of Positive Urine Measurements of Benzoylecgonine (BE) [ Time Frame: Day 1 up to day 98 ]
    Urine samples were analyzed for the presence of cocaine's metabolite benzoylecgonine (BE) which is the main metabolite of cocaine present in urine. Two urine samples were provided per week to provide a quantitative measure.

  2. Proportion of Days of Alcohol Consumption [ Time Frame: Day 1 up to day 98 ]
    Alcohol consumption was recorded by the subjects using the Timeline Follow-Back (TLFB) alcohol self report. The number of standard drinks were recorded daily. The proportion of days of alcohol consumption during the study treatment period was was compared using an ANCOVA model with treatment as factor and past alcohol consumption as covariate. The past consumption of alcohol was the proportion of alcohol over the 28 days preceding the screening visit, which was assessed retrospectively using the TLFB.

  3. AFQ056 Plasma Concentrations [ Time Frame: Day 15 (0h, 2h), Day 29 (0, 2h), Day 57 (0h, 2h), Day 98 (0h,2h) ]
    Plasma samples were collected to assess pharmacokinetics (PK)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242928


Locations
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Argentina
Novartis Investigative Site
Buenos Aires, Argentina, 1058
Novartis Investigative Site
Buenos Aires, Argentina, 4634
Novartis Investigative Site
Buenos Aires, Argentina, C1405B0A
Spain
Novartis Investigative Site
San Juan de Alicante, Alicante, Spain, 03550
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site
Barcelona, Spain, 08036
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4025
Novartis Investigative Site
Zuerich, Switzerland, 8001
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] November 15, 2017
Statistical Analysis Plan  [PDF] April 7, 2020

More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03242928    
Other Study ID Numbers: CAFQ056X2201
2017-000736-33 ( EudraCT Number )
First Posted: August 8, 2017    Key Record Dates
Results First Posted: February 4, 2021
Last Update Posted: October 8, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to to respect the privacy of patients who have participated in the trail in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalsutdydatarequest.com.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cocaine Use Disorder; cocaine dependence,AFQ056,adult, cocaine use,CUD, drug abuse, drug addiction,
Additional relevant MeSH terms:
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Disease
Cocaine-Related Disorders
Pathologic Processes
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders