Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy

NCT ID: NCT01813019

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

Brief Summary

The purpose of this study is to determine whether AFQ056 as an add on therapy to SSRIs can have beneficial effects by reducing the total score of Y-BOCS (Yale and Brown Obsessive Compulsive Scale) in OCD patients resistant to SSRI treatment (failed SSRI over 12 weeks at appropriate doses).

Detailed Description

This was a randomized, double-blind, parallel group, placebo-controlled, 12-weeks 200 mg b.i.d oral dose treatment of AFQ056 (following a 4 week up-titration period and followed by a 3 week down-titration period) or matched placebo in patients diagnosed with OCD and on background SSRI treatment for at least 12 weeks. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective.

Conditions

Patient Diagnosed With OCD and Resistant to SSRI Treatment; Failed SSRI Over 12 Weeks at Appropriate Doses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AFQ056

Following baseline, approximately 60 patients who are considered eligible will be randomized to AFQ056 arm and will receive the dosing regimen of 4 weeks AFQ056 b.i.d up-titration period of 50 mg,100 mg, 150 mg and 200 mg , followed by 12 weeks AFQ056 200 mg fixed dose* and then a 3 week down-titration of 100 mg, 50 mg and 25 mg AFQ056 b.i.d)

*patients that do not tolerate 200 mg b.i.d may be down-titrated to 150 mg b.i.d.

Group Type: EXPERIMENTAL

AFQ056

Intervention Type: DRUG

mGluR5 antagonist

Placebo

Following baseline, approximately 60 patients who are considered eligible will be randomized to Placebo arm and will receive the dosing regimen of 4 weeks Placebo b.i.d up-titration period of 50 mg,100 mg, 150 mg and 200 mg , followed by 12 weeks Placebo 200 mg fixed dose\* and then a 3 week down-titration of 100 mg, 50 mg and 25 mg Placebo b.i.d) \*patients that do not tolerate 200 matching placebo AFQ056 mg b.i.d may be down-titrated to 150 mg b.i.d.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo

Interventions

AFQ056

mGluR5 antagonist

Intervention Type: DRUG

Placebo

Matched placebo

Intervention Type: DRUG

Other Intervention Names

Mavoglurant

Eligibility Criteria

Inclusion Criteria

• Male and female , non-smokers patients aged between 18 to 65 years (inclusive),
• A primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR 4th ed, year 2000), as confirmed by an Independent Rater.
• Be on a stable appropriate dose of selective serotonin reuptake inhibitor (SSRI) treatment for at least 12 weeks prior to Baseline.
• Have an insufficient response to current SSRI treatment (as per Inclusion Criterion 4) and confirmed by an Independent Rater.
• Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of score ≥ 16 at Screening (and confirmed by an Independent Rater).
• Patient must have their eligibility confirmed following the remote interview conducted by the Independent Rater.
• Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria

• Diagnosis of primary OCD symptom of hoarding.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception (not including oral contraceptives) during dosing and for 30 days after last dosing of study medication.
• History of more than two unsatisfactory trials with different SSRI within a period of 2 years prior to screening (not including the current treatment with SSRI's given in an adequate dose for at least 12 weeks).
• Diagnosed with any primary DSM-IV-TR Axis I disorder other than OCD (as confirmed by an Independent Rater); with the exception of depression.
• History of eating disorder (e.g. anorexia, bulimia) according to DSMIV within the last 6 months prior to Screening, (as confirmed by an Independent Rater).
• Diagnosed with antisocial personality disorder (DSM-IV-TR Axis II), as confirmed by an Independent Rater.
• Has current or past medical history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, within the last 6 months prior to Screening.
• Smokers (use of tobacco products in the previous 3 months).
• History of hallucinations/psychosis that would require antipsychotic treatment or DSM-IV criteria being met
• Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

Watertown, Massachusetts, United States

Novartis Investigative Site

Brooklyn, New York, United States

Novartis Investigative Site

Burgas, Bulgaria, Bulgaria

Novartis Investigative Site

Pazardzhik, Bulgaria, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria, Bulgaria

Novartis Investigative Site

Varna, Bulgaria, Bulgaria

Novartis Investigative Site

Strakonice, Czech Republic, Czechia

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Nuremberg, , Germany

Novartis Investigative Site

Ulm, , Germany

Novartis Investigative Site

Bern, , Switzerland

Countries

United States; Bulgaria; Czechia; Germany; Switzerland

References

Rutrick D, Stein DJ, Subramanian G, Smith B, Fava M, Hasler G, Cha JH, Gasparini F, Donchev T, Ocwieja M, Johns D, Gomez-Mancilla B. Mavoglurant Augmentation in OCD Patients Resistant to Selective Serotonin Reuptake Inhibitors: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 Study. Adv Ther. 2017 Feb;34(2):524-541. doi: 10.1007/s12325-016-0468-5. Epub 2017 Jan 2.

Reference Type: DERIVED

PMID: 28044255 (View on PubMed)

Other Identifiers

CAFQ056A2225

Identifier Type: -

Identifier Source: org_study_id