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SchizophreniaPhase 2/3CLARITYNCT01363349

Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia

A Phase 2/3 study testing CYP-1020 and Risperidone in people with Schizophrenia and Cognitive Effect on Schizophrenic Patients, run by BioLineRx, Ltd. at 39 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints will occur after 12 and 24 weeks of… Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
CYP-1020 and Risperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
39 sitesin 3 countries
Study dates
May 2011to Apr 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or non-pregnant or lactating female, 18-50 years of age inclusive
  • Patients must have exhibited symptoms meeting the criteria of schizophrenia for at least one year, but not more than 20 years, prior to Screening
  • Recent onset (not more than 30 days) of worsening of psychiatric symptoms at Screening.
  • Currently experiencing an acute exacerbation of schizophrenia, as defined by the following results at Screening and Baseline:
  • ≥70 total score on the PANSS
  • ≥4 (moderate) on two of the following four PANSS items: (1) delusions, (2) hallucinatory behaviors, (3) conceptual disorganization or (4) suspiciousness/persecution, where at least one of the two items must be either delusions or hallucinatory behaviors
Show all 9Show fewer
  • CGI-S score between 4 and 6 (moderately ill to severely ill) at the Screening and Baseline visits.
  • Has exhibited a sufficient clinical response to at least one previous course of an anti-psychotic agent prescribed at a generally recognized therapeutic dose.
  • Must have completed at least 5 years of formal education or its equivalent

Who cannot join

  • Breastfeeding or pregnant
  • Symptoms of schizophrenia for more than 20 years at the time of screening.
  • Psychotic symptoms that have failed to improve (based on Investigator's opinion or documented medical history) following sufficient treatment with therapeutic doses of two or more anti-psychotics agents over the preceding 2 years
  • Prior history of neuroleptic malignant syndrome
  • Prior history or current evidence of moderate or severe tardive dyskinesia (mild is acceptable).
  • Abnormal ECG evaluation
Show all 19Show fewer
  • History of confirmed epilepsy or prior seizure disorder (history of a single febrile seizure is not exclusionary)
  • In the opinion of the investigator, unstable medical disease (e.g., malignancy, poorly controlled diabetes or hypertension, ischemic cardiac disease, dilated cardiomyopathy or valvular heart disease, pulmonary disease, liver disease, kidney disease)
  • Acute infectious disease (e.g., malaria, dengue fever, hepatitis A), or chronic infectious disease (e.g., history of AIDS or HIV positivity, tuberculosis)
  • Likely allergy, sensitivity or intolerance to BL-1020, perphenazine, risperidone, paliperidone, or any of the drug product excipients
  • Any suicide attempt within the preceding 2 years
  • Any Substance Dependence disorder
  • High likelihood of substance abuse
  • Diagnosis with one of the following DSM-IV-TR Axis I diagnoses: schizophreniform disorder, schizoaffective disorder, bipolar disorder, substance dependency, mood disorder with psychotic features; psychotic disorder NOS
  • Requiring chronic treatment with benzodiazepines
  • Requiring chronic treatment with mood stabilizers
  • Previously treated with clozapine within 6 months prior to screening
  • Any abnormal clinical laboratory test result that is judged by the Investigator to be clinically significant
  • History of, or serologic evidence of, acute or chronic active hepatitis B or C

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

India18 sites

  • Department of Psychiatry, Sheath VS General Hospital, Sheath KM School of Post Graduate Medicine & Research

    Ahmedabad

  • Spandana Nursing Home

    Bangalore

  • KHM Hospital

    Chennai

  • Saoji Tupkari Hospital

    Chhatrapati Sambhajinagar

  • Asha Hospital

    Hyderabad

  • Department of Psychiatry, Owaisi Hospital & Research Centre

    Hyderabad

  • RK Yadav Memorial Mental Health and De-addiction Hospital

    Jaipur

  • Mahendru Psychiatric Centre

    Kanpur

  • Dreamland Nursing Home

    Kolkata

  • Dayanand Medical College & Hospital

    Ludhiana

  • Centre for Psychiatric Research, Department of Psychiatry, K.S Hegde Medical Academy

    Mangalore

  • Jaslok Hospital&Research Centre

    Mumbai

  • JSS Medical College Hospital

    Mysore

  • Sujata Birla Hospital

    Nashik

  • Vimhans Hospital

    New Delhi

  • S.V.Medical College

    Tirupati

  • Deva Mental Health Care

    Varanasi

  • Vijayawada Institute of Mental Health & Neurosciences

    Vijayawada

Other trials in India

Romania18 sites

  • pitalul Clinic Judetean de Urgenta Arad Clinica Psihiatrie

    Arad

  • Spitalul de Psihiatrie si Neurologie Brasov

    Brasov

  • Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

    Bucharest

  • Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 13

    Bucharest

  • Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 1

    Bucharest

  • Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 8

    Bucharest

  • Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 9

    Bucharest

  • Spitalul de Psihiatrie C.E.T.T.T. "Sf. Stelian"

    Bucharest

  • Spitalul Judetean Cluj Napoca

    Cluj-Napoca

  • Spitalul Clinic Judetean de Urgenta Constanţa Clinica de Psihiatrie

    Constanța

  • Spitalul Clinic de Neuropsihiatrie Clinica de Psihiatrie nr. 2

    Craiova

  • Spitalul de Neuropsihiatrie Clinica de Psihiatrie I

    Craiova

  • Spitalul Clinic de Psihiatrie Socola

    Iași

  • Spital Clinic de Neurologie si Psihiatrie Oradea

    Oradea

  • Spitalul Clinic Municipal "Dr.Gavril Curteanu" Oradea

    Oradea

  • Spitalul de Psihiatrie "Dr. Gh. Preda"

    Sibiu

  • Spitalul Judetean de Urgenta Targoviste Clinica Psihiatrie Adulti nr. 7

    Targoviste

  • Spitalul Clinic Judetean Mures, Clinica Psihiatrie Nr. 2

    Târgu Mureş

Other trials in Romania

Moldova3 sites

  • IMSP Spitalul Clinic de Psihiatrie, Sectia 14

    Chisinau

  • IMSP Spitalul Clinic de Psihiatrie, Sectia 17

    Chisinau

  • IMSP Spitalul Clinic de Psihiatrie, Sectia 8

    Chisinau

Other trials in Moldova

About this study

Official title: A Randomized, Double-Blind, Active-Controlled,Phase 2/3 Study to Determine the Short-Term (6-Week) and Long-Term (6 Month) Cognitive and Anti-Psychotic Efficacy, Safety and Tolerability of CYP-1020 Compared to Risperidone in Patients With Schizophrenia

This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints will occur after 12 and 24 weeks of treatment.

Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study will utilize a flexible dose escalation scheme designed to allow patients to titrate to their maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a maximum of 35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID (2-6 mg daily). To ensure effective blinding across all treatment groups, all patients will be treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy design).

Being tested
CYP-1020, Risperidone
Medical subject headings
Schizophrenia

What participants receive

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

  • CYP-1020Drug

    Also called BL-1020

    CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.

  • RisperidoneDrug

Study groups in NCT01363349
Study groupRoleWhat they receive
CYP-1020ExperimentalDose titration 15-35mg/day for 6 months
Receives: Drug: CYP-1020
RisperidoneActive comparatorDose titration 2-6mg/day for 6 months
Receives: Drug: Risperidone

What is being measured

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

  1. Cognition

    To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.

    Measured: Baseline and 6 weeks

Secondary outcomes (2)

  1. Long Term Cognition

    Evaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment

    Measured: 12 and 24 weeks of treatment

  2. Long Term Schizophrenia Treatment

    Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment

    Measured: Baseline and 6, 12 and 24 weeks of treatment

Timeline

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

  1. First posted1 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMar 2013
  4. Study completionApr 2013

Why it stopped: pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020 indicate that the trial would not meet the pre-specified primary efficacy endpoint.

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01363349
Sponsor's protocol ID
1020-CLIN-201
Acronym
CLARITY
Status last verified
Sep 2014
First submitted
30 May 2011
Last updated
18 Sep 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CYP-1020 and Risperidone in people with Schizophrenia and Cognitive Effect on Schizophrenic Patients, run by BioLineRx, Ltd. at 39 sites in 3 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 19 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: stopped early, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in India, Romania, Moldova. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cognition (time frame: Baseline and 6 weeks). 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 NCT01363349.

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 18 Sep 2014.

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