A Phase 2 Efficacy and Safety Study of TAK-063 in Participants With an Acute Exacerbation of Schizophrenia

NCT02477020 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: TAK-063-2002U1111-1169-6472
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063 compared with placebo in treatment of acutely exacerbated schizophrenia.

Conditions

Schizophrenia

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Positive and Negative Symptom Scale (PANSS) Total Score at Week 6

  PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a mixed model for repeated measures (MMRM). A negative change from Baseline indicates improvement.

  Baseline and Week 6

Secondary Outcomes (11)

• Change From Baseline in PANSS Total Score at Weeks 1, 2, 3, 4 and 5

  Baseline and Weeks 1, 2, 3, 4 and 5

• Change From Baseline in PANSS Subscales Using the Marder 5-factor Model at Weeks 1, 2, 3, 4, 5, and 6

  Baseline and Weeks 1, 2, 3, 4, 5 and 6

• Change From Baseline in PANSS Subscales at Weeks 1, 2, 3, 4, 5 and 6

  Baseline and Weeks 1, 2, 3, 4, 5 and 6

• Percentage of Clinical Responders Based on the PANSS Total Score

  Weeks 1, 2, 3, 4, 5 and 6

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Weeks 1, 2, 3, 4, 5,and 6

  Baseline, Weeks 1, 2, 3, 4, 5 and 6

Study Arms (2)

TAK-063 20 mg

EXPERIMENTAL

TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks. Dose may be titrated down to 10 mg/day, if intolerable.

Drug: TAK-063 20 mg

Placebo

PLACEBO COMPARATOR

TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.

Drug: Placebo

Interventions

TAK-063 20 mg DRUG

TAK-063 tablet.

TAK-063 20 mg

Placebo DRUG

TAK-063 matching-placebo tablet.

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:

• Is capable of understanding and complying with protocol requirements.
• The participants or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Has a primary diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition \[DSM-5\], 295.90) confirmed by clinical interview (Structured Clinical Interview for DSM-5 Clinical Trial Version \[SCID-5-CT\]). The participant's initial diagnosis must be greater than or equal to (\>=) 1 year from screening.
• Is a man or woman age 18 to 65, inclusive, at Screening.
• Male participant who is nonsterilized and sexually active with a female partner of child bearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
• Female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
• The participant's psychotic symptoms were exacerbated within 2 months (60 days) prior to Screening (example, aggravated delusion).
• Has a score of 5 (moderate severe) or higher in 3 or more items of the following Positive and Negative Symptom Scale (PANSS) items at Screening and Day 1: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), and unusual thought content (G9).
• Has a PANSS total score of 80 or higher at Screening and Day 1.
• Has a Clinical Global Impression Scale- Severity of Illness Scale (CGI-S) of 4 or greater at Screening and Day 1.
• Is able and agrees to remain off prior antipsychotic medication and all excluded medications as outlined in the protocol for the duration of the study.
• Has an identified, reliable caregiver. A caregiver is defined as a family member, informant or friend who is able and willing to assist and support the administration of study drug, adherence to protocol requirements and to the study schedule.
• Has a body mass index (BMI) score between 18.0 and 35.0 kilogram per square meter (kg/m\^2), inclusive, at Screening.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Screening, or within 5 half-lives prior to screening, whichever is longer.
• Has received TAK-063 in a previous clinical study or as a therapeutic agent or has previously or is currently participating in this study or have participated in 2 or more clinical studies within 12 months prior to Screening.
• Has a decrease in the PANSS Total Score by 20 percent (%) or more at Baseline (Day 1) compared with that at Screening \[(PANSS Total Score at Screening- PANSS total score at Baseline)/(PANSS Total Score at Screening- 30)\]\*100 \>=20%\].
• Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, and sibling) or may consent under duress.
• Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
• Has a history of severe head injury/traumatic brain injury, myocardial infarction or stroke.
• Has a known hypersensitivity to any component of the formulation of TAK-063 or the practice pills (i.e., small colored candies) during the AiCure device training.
• Has a positive urine drug result (illicit, illegal or without valid prescription or medical need) at Screening.
• Has a moderate or severe substance use disorder (meeting more than 5 diagnostic criteria of DSM-5 either currently or within the last 6 months) for alcohol or other substances of abuse except nicotine or caffeine.
• Has taken any excluded medication, supplements, or food products or has had insufficient washout of medications, supplements, or food products as listed in the Excluded /Allowed Medications, Procedures, and Treatments table or is unable or unwilling to discontinue medications as required by the protocol.
• If female, the participant is pregnant or lactating or intending to become pregnant (a positive pregnancy test at Screening or Day 1), or intending to donate ova, before or during the course of the study or within 12 weeks after last dose.
• If male, the participant intends to donate sperm during the course of this study or for 12 weeks after last dose.
• Has a psychiatric disorder other than schizophrenia as their primary diagnosis.
• Has a history of or known personality disorder or other psychiatric disorder that, in the opinion of the investigator, would interfere with participation in the study.
• Has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus or other conditions that may interfere with absorption of study medication.

Sponsors & Collaborators

• Takeda: lead

Study Sites (15)

Unknown Facility

Springdale, Alaska, United States

Location

Unknown Facility

Culver City, California, United States

Location

Unknown Facility

Lemon Grove, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Pico Rivera, California, United States

Location

Unknown Facility

Lauderhill, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Lake Charles, Louisiana, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Related Publications (2)

• Macek TA, McCue M, Dong X, Hanson E, Goldsmith P, Affinito J, Mahableshwarkar AR. A phase 2, randomized, placebo-controlled study of the efficacy and safety of TAK-063 in subjects with an acute exacerbation of schizophrenia. Schizophr Res. 2019 Feb;204:289-294. doi: 10.1016/j.schres.2018.08.028. Epub 2018 Sep 3.

  PMID: 30190165 DERIVED

• Tohyama K, Sudo M, Morohashi A, Kato S, Takahashi J, Tagawa Y. Pre-clinical Characterization of Absorption, Distribution, Metabolism and Excretion Properties of TAK-063. Basic Clin Pharmacol Toxicol. 2018 Jun;122(6):577-587. doi: 10.1111/bcpt.12964. Epub 2018 Feb 26.

  PMID: 29345044 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

1-(2-fluoro-4-(1H-pyrazol-1-yl)phenyl)-5-methoxy-3-(1-phenyl-1H-pyrazol-5-yl)pyridazin-4(1H)-one

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Takeda (Note: This product was divested to Axsome in 2026)

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda (Note: This product was divested to Axsome in 2026)

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 22, 2015
• Study Start: July 1, 2015
• Primary Completion: July 13, 2016
• Study Completion: July 27, 2016
• Last Updated: May 8, 2026
• Results First Posted: September 29, 2017

Record last verified: 2026-04

Locations

US (15)