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Chronic SchizophreniaPhase 2NCT02624167

A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia

A Phase 2 study testing NW-3509A in people with Chronic Schizophrenia, run by Newron Pharmaceuticals SPA at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Schizophrenia
What is being tested?
NW-3509A
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
5 sitesin 2 countries
Study dates
Dec 2015to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male/female; if female, must not of childbearing potential
  • 18 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.
Show all 9Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

India3 sites

  • Tirthalli National Institute of Mental Health and Neurosciences

    Bangalore, 560-029

  • KHM Hospital

    Chennai, Tamil Nadu, 600 040

  • Ahana Hospital

    Madurai, Tamil Nadu, 625020

Other trials in India

United States2 sites

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Collaborative Neuroscience Network.

    Garden Grove, California, 92845

Other trials in United States

About this study

Official title: A Phase IIA, Prospective, Randomized, Double-blind, Multiple-dose Study of NW-3509A in Chronic Schizoprhenia Patients Not Responding to Their Current Anti-psychotic Medication

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.

Read the detailed description

This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, and preliminary efficacy of an oral dose range of NW-3509A of 30 to 50 mg/day (15 to 25 mg, BID) in patients with chronic schizophrenia on a stable dose of an antipsychotic (aripiprazole or risperidone). A minimum of 90 patients will be randomized in a 1:1 ratio to receive either NW-3509A (n=45) or placebo (n=45). Dose increases will be performed only during in-patient setting.

Safety and efficacy assessments will be done on a weekly basis during the randomized treatment period. The assessment of safety will be based on laboratory tests (biochemistry, hematology, and urinalysis), 12-lead standard ECG, vital signs, physical examinations, neurological examinations, C-SSRS, ESRS-A, subjective reporting of any AE by the subject, objective observation of any AE by the Investigator. Pharmacokinetic samples will be taken at various time-points. Efficacy assessments will include the PANSS, CGI-C, CGI-S and the Strauss-Carpenter Level of Functioning (LOF) scale.

Being tested
NW-3509A, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NW-3509ADrug

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

  • PlaceboDrug

    Patients will be given oral dose of matching Placebo

Study groups in NCT02624167
Study groupRoleWhat they receive
NW-3509AActive comparatorPatients will start on NW-3509A 15 mg BID and be up-titrated to 20mg, and 25mg BID dependent on tolerability.
Receives: Drug: NW-3509A
PlaceboPlacebo comparatorPatients will receive matching placebo BID
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 27 days

Secondary outcomes (4)

  1. Assessment of Positive and Negative Syndrome Scale (PANSS)

    Assessment of the PANSS - a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control, will be carried out at every visit

    Measured: 27 days

  2. Assessment of CGI-S (severity) and CGI-C (change)

    Measure of change from baseline will be done at every assessment

    Measured: 27 days; change from baseline

  3. Assessment of Strauss-Carpenter Level of Functioning (LOF) scale

    The LOF scale will be used at baseline and end of study, to evaluate the clinical outcome

    Measured: 27 days; baseline and end of study

  4. Measurement of plasma concentration Cmax

    Blood samples will be collected for PK evaluation at time points

    Measured: 27 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02624167
Sponsor's protocol ID
NW-3509A/002/II/2015
Status last verified
Mar 2017
First submitted
20 Nov 2015
Last updated
14 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44.

    PubMed 8110442

  • Casey DE, Daniel DG, Wassef AA, Tracy KA, Wozniak P, Sommerville KW. Effect of divalproex combined with olanzapine or risperidone in patients with an acute exacerbation of schizophrenia. Neuropsychopharmacology. 2003 Jan;28(1):182-92. doi: 10.1038/sj.npp.1300023.

    PubMed 12496955

  • Chahine M, Chatelier A, Babich O, Krupp JJ. Voltage-gated sodium channels in neurological disorders. CNS Neurol Disord Drug Targets. 2008 Apr;7(2):144-58. doi: 10.2174/187152708784083830.

    PubMed 18537643

  • Chouinard G, Margolese HC. Manual for the Extrapyramidal Symptom Rating Scale (ESRS). Schizophr Res. 2005 Jul 15;76(2-3):247-65. doi: 10.1016/j.schres.2005.02.013. Epub 2005 Apr 18.

    PubMed 15949657

  • Citrome L. Schizophrenia and valproate. Psychopharmacol Bull. 2003;37 Suppl 2:74-88.

    PubMed 15021863

  • 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.

  • 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.

    PubMed 24458010

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

  • 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.

  • 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.

    PubMed 3616518

  • 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.

    PubMed 16172203

  • 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.

    PubMed 19102711

  • 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.

    PubMed 17606655

  • Stingl J, Viviani R. Polymorphism in CYP2D6 and CYP2C19, members of the cytochrome P450 mixed-function oxidase system, in the metabolism of psychotropic drugs. J Intern Med. 2015 Feb;277(2):167-177. doi: 10.1111/joim.12317.

    PubMed 25297512

  • 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.

    PubMed 843175

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NW-3509A in people with Chronic Schizophrenia, run by Newron Pharmaceuticals SPA at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: 27 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02624167, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.

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