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

NCT01813019 | Terminated Phase 2 Results DMC

• 1 other identifier: CAFQ056A2225
• Study Type: interventional
• Target: 50
• Locations: 5 countries
• Sites: 15

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).

Conditions

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

Keywords

Obsessive compulsive disorder (OCD), obsessive fears, obsessions,; compulsions, OCD SSRI resistant

Outcome Measures

Primary Outcomes (1)

• Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing).

  The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of OCD without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions. Each item is rated from 0 ("no symptoms") to 4 ("extreme symptoms") and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity: 0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme Baseline was compared to week 17 (end of week 16 dosing) to produce an absolute change.

  baseline, week 17

Secondary Outcomes (1)

• Y-BOCS Reduction in Total Score From Baseline

  16 weeks

Study Arms (2)

AFQ056

EXPERIMENTAL

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.

Drug: AFQ056

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

AFQ056 DRUG

mGluR5 antagonist

Also known as: Mavoglurant

AFQ056

Placebo DRUG

Matched placebo

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:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Novartis Investigative Site

San Diego, California, 92103, United States

Location

Novartis Investigative Site

Watertown, Massachusetts, 02472, United States

Location

Novartis Investigative Site

Brooklyn, New York, 11229, United States

Location

Novartis Investigative Site

Burgas, Bulgaria, 8000, Bulgaria

Location

Novartis Investigative Site

Pazardzhik, Bulgaria, 4400, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1431, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1632, Bulgaria

Location

Novartis Investigative Site

Varna, Bulgaria, 9020, Bulgaria

Location

Novartis Investigative Site

Strakonice, Czech Republic, 386 29, Czechia

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

München, 80336, Germany

Location

Novartis Investigative Site

Nuremberg, 90419, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28044255 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Obsessive Behavior; Compulsive Behavior

Interventions

mavoglurant

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Impulsive Behavior

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

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: March 14, 2013
• First Posted: March 18, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 2, 2017
• Results First Posted: July 21, 2016

Record last verified: 2016-11

Locations

BU (5); DE (5); CH (1); CZ (1); US (3)