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Efficacy of Lu 31-130 in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zicronapine
Olanzapine
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic, Olanzapine, Lu 31-130

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject has a primary diagnosis of schizophrenia
  • The subject experiences clinically significant symptoms
  • The subject is willing to be hospitalized during the initial period of the study
  • The subject has normal serum values of parameters associated with liver function

Sites / Locations

  • CZ001
  • CZ005
  • CZ004
  • CZ002
  • CZ003
  • CZ006
  • FR001
  • FR002
  • FR003
  • HK001
  • ID001
  • ID002
  • PH002
  • PH001
  • PL003
  • PL002
  • ES001
  • ES002
  • ES004
  • TH001
  • TH002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zicronapine

Olanzapine

Arm Description

Outcomes

Primary Outcome Measures

Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12

Secondary Outcome Measures

Change in cognitive symptoms using Assessment of Cognition in Schizophrenia (BACS) test battery. Change in Clinical Global Impression/Improvement (CGI-S/I) scores. Change in Calgary Depression Scale for Schizophrenia (CDSS) score. Safety assessments.

Full Information

First Posted
October 9, 2008
Last Updated
November 7, 2016
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00770744
Brief Title
Efficacy of Lu 31-130 in Patients With Schizophrenia
Official Title
A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Exploring the Efficacy and Safety of 12 Weeks Treatment With Lu 31-130 in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.
Detailed Description
Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. However, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptom domains. Whereas positive symptoms respond to treatment the effects on negative symptoms and cognitive impairment are only very modest. Thus present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. In the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. Eligible patients will be randomised to blinded treatment with either flexible doses of Lu 31-130 or flexible doses of a standard antipsychotic treatment (olanzapine) for 12 weeks. The efficacy (including potential effects on cognitive symptoms) and the safety of Lu 31-130 will be explored in comparison to olanzapine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotic, Olanzapine, Lu 31-130

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zicronapine
Arm Type
Experimental
Arm Title
Olanzapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zicronapine
Other Intervention Name(s)
Lu 31-130
Intervention Description
5-7mg/day; orally, encapsulated tablets, once daily
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
10-15mg/day; orally, encapsulated tablets, once daily
Primary Outcome Measure Information:
Title
Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in cognitive symptoms using Assessment of Cognition in Schizophrenia (BACS) test battery. Change in Clinical Global Impression/Improvement (CGI-S/I) scores. Change in Calgary Depression Scale for Schizophrenia (CDSS) score. Safety assessments.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject has a primary diagnosis of schizophrenia The subject experiences clinically significant symptoms The subject is willing to be hospitalized during the initial period of the study The subject has normal serum values of parameters associated with liver function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
CZ001
City
Ceske Budejovice
ZIP/Postal Code
37087
Country
Czech Republic
Facility Name
CZ005
City
Litomerice
ZIP/Postal Code
41201
Country
Czech Republic
Facility Name
CZ004
City
Lnare
ZIP/Postal Code
38742
Country
Czech Republic
Facility Name
CZ002
City
Olomouc
ZIP/Postal Code
77111
Country
Czech Republic
Facility Name
CZ003
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
CZ006
City
Praha 8
ZIP/Postal Code
18100
Country
Czech Republic
Facility Name
FR001
City
Clermont-Ferrand, Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
FR002
City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
FR003
City
Jonzac
ZIP/Postal Code
17503
Country
France
Facility Name
HK001
City
Hong Kong
Country
Hong Kong
Facility Name
ID001
City
Bangli
ZIP/Postal Code
80613
Country
Indonesia
Facility Name
ID002
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Name
PH002
City
Baguio
ZIP/Postal Code
2600
Country
Philippines
Facility Name
PH001
City
Mandaluyong City
ZIP/Postal Code
1553
Country
Philippines
Facility Name
PL003
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
PL002
City
Lodz
ZIP/Postal Code
92-216
Country
Poland
Facility Name
ES001
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
ES002
City
Salamanca
ZIP/Postal Code
37003
Country
Spain
Facility Name
ES004
City
Zamora
ZIP/Postal Code
49021
Country
Spain
Facility Name
TH001
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
TH002
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Available IPD and Supporting Information:
Available IPD/Information Type
EMA EudraCT Results
Available IPD/Information URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-000479-11/results
Available IPD/Information Identifier
2008-000479-11

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Efficacy of Lu 31-130 in Patients With Schizophrenia

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