Study to evaluate the effect of AMG 747 on schizophrenia negative symptoms (20101299)

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2011-004844-23-IT
• Date of registration: 31/10/2012
• Prospective Registration: Yes
• Primary sponsor: AMGEN INC.
• Public title: Study to evaluate the effect of AMG 747 on schizophrenia negative symptoms (20101299)
• Scientific title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms (Study 299) - Study 299
• Date of first enrolment: 17/11/2012
• Target sample size: 270
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004844-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, European Union, Italy, New Zealand, Russian Federation, Singapore, Spain, United States

Contacts

• Name: Dip. Regolatorio
• Affiliation: Amgen Dompé S.p.A.

• Name: Dip. Regolatorio
• Affiliation: Amgen Dompé S.p.A.

Key inclusion & exclusion criteria

Inclusion criteria:
- Adults, 18-60 years of age upon entry into screening; - Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia; - Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) = 20, Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) = 30; - Receiving stable antipsychotic therapy for at least 8 weeks prior to screening; - Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening; - Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study; - Subject or subject's legally acceptable representative has provided informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Current schizoaffective disorder, bipolar disorder, panic disorder, or obsessive compulsive disorder, or evidence of mental retardation by history or clinical examination or known premorbid IQ = 70; - Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or current active suicidal ideation; - Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening; - Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening or during screening; - Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study; - Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia
MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

Product Name: AMG 747
Product Code: AMG 747
Pharmaceutical Form: Tablet
Current Sponsor code: AMG 747
Other descriptive name: (4-{(R)-phenyl[3-(trifluoromethyl)phenyl]methyl} piperazin-1-yl)acetic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: AMG 747
Product Code: AMG 747
Pharmaceutical Form: Tablet
Current Sponsor code: AMG 747
Other descriptive name: (4-{(R)-phenyl[3-(trifluoromethyl)phenyl]methyl} piperazin-1-yl)acetic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: AMG 747
Product Code: AMG 747
Pharmaceutical Form: Tablet
Current Sponsor code: AMG 747
Other descriptive name: (4-{(R)-phenyl[3-(trifluoromethyl)phenyl]methyl} piperazin-1-yl)acetic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12

Main Objective: To evaluate the treatment effect of AMG 747 compared to placebo on negative symptoms as measured by the Negative Symptom Assessment Scale (NSA-16) in patients with schizophrenia stabilized with ongoing antipsychotic therapy

Primary end point(s): Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score

Secondary Objective: - To evaluate the effect of AMG 747 on the proportion of subjects achieving clinically meaningful improvement from baseline, as defined by a = 20% decrease from baseline on negative symptoms as measured by the NSA-16; - To evaluate the effect of AMG 747 on symptoms of schizophrenia as measured by the PANSS total score and Marder factor scores; - To evaluate the effect of AMG 747 on global change as measured by the CGI-S and CGI-I scales; - To evaluate the effect of AMG 747 on cognitive function as measured by the MATRICS Consensus Cognitive Battery (MCCB); - To evaluate the effect of AMG 747 on everyday functioning as measured by the PSP scale; - To evaluate the effect of AMG 747 on PROs as measured by the Q-LESQ- 18 and SDS; - To evaluate safety and tolerability of AMG 747.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12

Secondary end point(s): - Response defined as a = 20% decrease in the NSA-16 total score at week 12; - Change from baseline to week 12 on the PANSS total score and Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression symptoms); - Change from baseline to week 12 on the CGI-S; - CGI-I scores at week 12; - Change from baseline to week 12 on the MCCB; - Change from baseline to week 12 on the PSP; - Change from baseline to week 12 on the Q-LES-Q-18 and SDS; Safety Endpoints: - Adverse events; - Clinical laboratory values and vital signs; - 12-lead ECG; - Calgary Depression Scale for Schizophrenia (CDSS), Columbia-Suicide Severity Rating Scale (C-SSRS), Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Scale (SAS).

Secondary ID(s)

20101299

2011-004844-23-ES

Source(s) of Monetary Support

Amgen Inc.

Ethics review

Status: Approved
Approval date: 16/10/2012
Contact:

Results

• Results available: Yes
• Date Posted: 06/11/2016
• Date Completed: 14/06/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004844-23/results