NCT02624167

Brief Summary

A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in patients with chronic schizophrenia that are not responding adequately to their current antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose range of 15 to 25 mg, BID in a 1:1 ratio.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

November 20, 2015

Last Update Submit

March 13, 2017

Conditions

Chronic Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of NW-3509A in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).

    To evaluate the safety and tolerability of NW-3509A given as an oral dose range of 30 to 50 mg/day (15 to 25 mg, BID) in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).

    27 days

Secondary Outcomes (4)

  • Assessment of Positive and Negative Syndrome Scale (PANSS)

    27 days

  • Assessment of CGI-S (severity) and CGI-C (change)

    27 days; change from baseline

  • Assessment of Strauss-Carpenter Level of Functioning (LOF) scale

    27 days; baseline and end of study

  • Measurement of plasma concentration Cmax

    27 days

Study Arms (2)

NW-3509A

ACTIVE COMPARATOR

Patients will start on NW-3509A 15 mg BID and be up-titrated to 20mg, and 25mg BID dependent on tolerability.

Drug: NW-3509A

Placebo

PLACEBO COMPARATOR

Patients will receive matching placebo BID

Drug: Placebo

Interventions

NW-3509ADRUG

Patients will be given oral doses of 15, 20 and 25 mg BID of NW-3509A

NW-3509A
PlaceboDRUG

Patients will be given oral dose of matching Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/female; if female, must not of childbearing potential
  • to 65 years of age, inclusive;
  • Has a current diagnosis of schizophrenia
  • Has a total score on the PANSS \< 75.
  • Positive symptoms sub-scale score not to exceed 15; score of ≥4 on no more than 2 positive symptoms
  • Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly to moderately severely ill.
  • Is in need of anti-psychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening of oral risperidone or aripiprazole (at least 2 mg risperidone dose-equivalent).
  • Current symptoms present for at least one month.
  • Patient agrees to be hospitalized for up to 2 days at the start of dosing and at each dose increase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Collaborative Neuroscience Network.

Garden Grove, California, 92845, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

KHM Hospital

Chennai, Tamil Nadu, 600 040, India

Location

Ahana Hospital

Madurai, Tamil Nadu, 625020, India

Location

Tirthalli National Institute of Mental Health and Neurosciences

Bangalore, 560-029, India

Location

Related Publications (19)

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    PMID: 8110442BACKGROUND

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    PMID: 15949657BACKGROUND

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    PMID: 15021863BACKGROUND

  • Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, May 28, 2009 (v4.03 June 14, 2010), U.S. Department of Health and Human Services.

    BACKGROUND

  • Crews KR, Gaedigk A, Dunnenberger HM, Leeder JS, Klein TE, Caudle KE, Haidar CE, Shen DD, Callaghan JT, Sadhasivam S, Prows CA, Kharasch ED, Skaar TC; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium guidelines for cytochrome P450 2D6 genotype and codeine therapy: 2014 update. Clin Pharmacol Ther. 2014 Apr;95(4):376-82. doi: 10.1038/clpt.2013.254. Epub 2014 Jan 23.

    PMID: 24458010BACKGROUND

  • Goldberg DP, Williams P. A User's Guide to the General Health Questionnaire. 1988. Windsor: NFER-Nelson.

    BACKGROUND

  • Guy W (Ed). Clinical Global Impressions. In ECDEU Assessment Manual for Psychopharmacology, revised, U.S. Department of Health, Education and Welfare Pub. No. (ADM) 76-338. Rockville, MD: NIMH, 1976, 217-222.

    BACKGROUND

  • Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

    PMID: 3616518BACKGROUND

  • Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.

    PMID: 16172203BACKGROUND

  • Llerena A, Dorado P, Penas-Lledo EM. Pharmacogenetics of debrisoquine and its use as a marker for CYP2D6 hydroxylation capacity. Pharmacogenomics. 2009 Jan;10(1):17-28. doi: 10.2217/14622416.10.1.17.

    PMID: 19102711BACKGROUND

  • Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035.

    PMID: 17606655BACKGROUND

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    PMID: 25297512BACKGROUND

  • Strauss JS, Carpenter WT Jr. Prediction of outcome in schizophrenia. III. Five-year outcome and its predictors. Arch Gen Psychiatry. 1977 Feb;34(2):159-63. doi: 10.1001/archpsyc.1977.01770140049005.

    PMID: 843175BACKGROUND

  • Tiihonen J, Wahlbeck K, Kiviniemi V. The efficacy of lamotrigine in clozapine-resistant schizophrenia: a systematic review and meta-analysis. Schizophr Res. 2009 Apr;109(1-3):10-4. doi: 10.1016/j.schres.2009.01.002. Epub 2009 Jan 30.

    PMID: 19186030BACKGROUND

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    PMID: 1593914BACKGROUND

  • Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: Part I. Clin Pharmacokinet. 2009;48(11):689-723. doi: 10.2165/11318030-000000000-00000.

    PMID: 19817501BACKGROUND

  • Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: part II. Clin Pharmacokinet. 2009;48(12):761-804. doi: 10.2165/11318070-000000000-00000.

    PMID: 19902987BACKGROUND

Study Officials

  • Ravi Anand, MD

    Newron Pharmaceuticals SPA

    STUDY DIRECTOR

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

November 20, 2015

First Posted

December 8, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(3)US(2)