Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02970305
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE November 4, 2016
Actual Primary Completion Date October 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
Change from Baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) total score [ Time Frame: 26 weeks ]
Efficacy of pimavanserin compared with placebo in the adjunctive treatment of the negative symptoms of schizophrenia measured with Negative Symptom Assessment (NSA-16)
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
Efficacy of pimavanserin in the adjunctive treatment of negative symptoms of schizophrenia [ Time Frame: Approximately 34 weeks ]
Efficacy of pimavanserin compared with placebo in the adjunctive treatment of the negative symptoms of schizophrenia measured with Negative Symptom Assessment (NSA-16)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
Brief Summary To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of the negative symptoms of schizophrenia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Pimavanserin
    Pimavanserin 34 mg, 20 mg, or 10 mg, taken as two tablets, once daily by mouth
  • Drug: Placebo
    Placebo, taken as two tablets, once daily by mouth
Study Arms  ICMJE
  • Experimental: Pimavanserin
    Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
    Intervention: Drug: Pimavanserin
  • Placebo Comparator: Placebo
    Placebo, taken as two tablets, once daily by mouth
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2019)
403
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2016)
380
Actual Study Completion Date  ICMJE October 28, 2019
Actual Primary Completion Date October 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult patients, between 18 and 55 years of age
  2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year
  3. Has predominant negative symptoms according to predefined study criteria
  4. 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:

  1. Patient has a psychiatric disorder other than schizophrenia
  2. 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

  3. 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
  4. Patient has had a myocardial infarction in the last six months
  5. Patient has a family or personal history or symptoms of long QT syndrome
  6. 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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czechia,   Hungary,   Poland,   Russian Federation,   Serbia,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970305
Other Study ID Numbers  ICMJE ACP-103-038
2016-003436-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ACADIA Pharmaceuticals Inc.
Study Sponsor  ICMJE ACADIA Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ACADIA Pharmaceuticals Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP