Phase 2 N=403 Randomized Quadruple-blind Treatment

Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT02970305 ↗

Enrolled (actual)

403

Serious AEs

1.2%

Results posted

Dec 2020

Primary outcome: Primary: Change From Baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) Total Score — 61.8; 61.0; -10.5; -8.8 score on a scale — p=0.0434

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pimavanserin (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: ACADIA Pharmaceuticals Inc.
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) Total Score	61.8; 61.0; -10.5; -8.8	0.0434 sig
SECONDARY Change From Baseline to Week 26 in the Personal and Social Performance Scale (PSP) Score	47.2; 46.7; 8.1; 8.4	—
SECONDARY Proportion of Negative Symptom Assessment-16 (NSA-16) Responders at Week 26	93; 84; 56; 51; 21; 16	—
SECONDARY Change From Baseline to Week 26 in NSA-16 Global Negative Symptoms Rating	4.7; 4.8; -0.7; -0.7	—
SECONDARY Change From Baseline (CFB) to Week 26 in NSA-16 Domain Scores	12.3; 12.3; -2.4; -2.0; 12.7; 12.5	—
SECONDARY Change From Baseline to Week 26 in the Clinical Global Impression of Schizophrenia Scale-Severity (CGI-SCH-S) of Negative Symptoms Score	4.6; 4.7; -0.6; -0.6	—
SECONDARY Clinical Global Impression of Schizophrenia Scale-Improvement (CGI-SCH-I) of Negative Symptoms Score at Week 26	3.1; 3.1	—
SECONDARY Proportion of CGI-SCH-I Responders (CGI-SCH-I Score of 1 or 2) at Week 26; Observed Cases	47; 40	—
SECONDARY Change From Baseline to Week 26 in the Positive and Negative Syndrome Scale (PANSS) Total Score	77.2; 79.4; -8.7; -8.6	—
SECONDARY Change From Baseline (CFB) to Week 26 in PANSS Subscale Scores	13.1; 13.7; -0.6; -0.8; 27.5; 27.5	—
SECONDARY Change From Baseline to Week 26 in Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score	22.94; 20.99; 3.33; 4.16	—
SECONDARY Change From Baseline to Week 26 in 10-item Drug Attitude Inventory (DAI-10) Score	5.7; 5.7; 0.2; 0.2	—
SECONDARY Change From Baseline to Week 26 in Karolinska Sleepiness Scale (KSS) Score	4.6; 4.8; -0.3; -0.6	—

Summary

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of the negative symptoms of schizophrenia

Eligibility Criteria

Inclusion Criteria

Adult patients, between 18 and 55 years of age
A clinical diagnosis of schizophrenia with a minimum duration of 1 year
Has predominant negative symptoms according to predefined study criteria
The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:
Aripiprazole
Aripiprazole long-acting injectables:
Abilify Maintena®
Aristada®
Risperidone
Risperidone long-acting injection
Olanzapine
Lurasidone
Cariprazine
Brexpiprazole
Asenapine

Exclusion Criteria

Patient has a psychiatric disorder other than schizophrenia
A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation

Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
Patient has had a myocardial infarction in the last six months
Patient has a family or personal history or symptoms of long QT syndrome
Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02970305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.