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Efficacy of Lu 31-130 in Patients With Schizophrenia

NCT ID: NCT00768326

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-11-30

Brief Summary

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The main purpose with the study is to evaluate the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to placebo.

Detailed Description

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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 symptoms of the disease. Thus, only one dimension of the morbidity, that is, the positive symptoms, can be expected to respond to treatment whereas negative symptoms and cognitive deficits are, at best, only marginally targeted.

Given this, there is no doubt that the current antipsychotic drugs leave much room for improvement and call for new, more effective pharmacotherapies in the treatment of schizophrenia. In the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. In the current study, eligible patients will be randomised in a 2:1 ratio to blinded treatment with either Lu 31-130 (3, 5, 7, 10 or 14 mg/day) or placebo for 8 weeks. The study includes 5 parts with increasing doses of Lu 31-130 (Part A \[3 mg/day\], B \[5 mg/day\], C \[7 mg/day\], D \[10 mg/day\], and E \[14 mg/day\]). A decision to initiate Part B \[5 mg/day of Lu 31-130\], C \[7 mg/day of Lu 31-130\] or D \[10 mg/day of Lu 31-130\] will be based on safety and tolerability of the previous study part. Dependent on the safety, tolerability and PK data from Part D the study may proceed with Part E. The efficacy and the safety of Lu 31-130 will be evaluated in comparison to the pooled placebo group from all 5 study parts.

Conditions

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Schizophrenia

Keywords

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Schizophrenia Antipsychotic Lu 31-130

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Zicronapine. Study Part A

Group Type EXPERIMENTAL

Zicronapine

Intervention Type DRUG

Study Part A:

3mg; orally, film-coated tablets, once daily, 8 weeks

Zicronapine. Study Part B

Group Type EXPERIMENTAL

Zicronapine

Intervention Type DRUG

Study Part B:

5mg; orally, film-coated tablets, once daily, 8 weeks

Zicronapine. Study Part C

Group Type EXPERIMENTAL

Zicronapine

Intervention Type DRUG

Study Part C:

7mg; orally, film-coated tablets, once daily, 8 weeks

Zicronapine. Study Part D

Group Type EXPERIMENTAL

Zicronapine

Intervention Type DRUG

Study Part D:

2 x 5mg; orally, film-coated tablets, once daily, 8 weeks

Zicronapine. Study Part E

Group Type EXPERIMENTAL

Zicronapine

Intervention Type DRUG

Study Part E:

2 x 7mg; orally, film-coated tablets, once daily, 8 weeks

2A, 2B, 2C, 2D, 2E

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Study Part A, B, C, D and E:

Placebo; orally, film-coated tablets, once daily, 8 weeks

Interventions

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Zicronapine

Study Part A:

3mg; orally, film-coated tablets, once daily, 8 weeks

Intervention Type DRUG

Zicronapine

Study Part B:

5mg; orally, film-coated tablets, once daily, 8 weeks

Intervention Type DRUG

Zicronapine

Study Part C:

7mg; orally, film-coated tablets, once daily, 8 weeks

Intervention Type DRUG

Zicronapine

Study Part D:

2 x 5mg; orally, film-coated tablets, once daily, 8 weeks

Intervention Type DRUG

Zicronapine

Study Part E:

2 x 7mg; orally, film-coated tablets, once daily, 8 weeks

Intervention Type DRUG

Placebo

Study Part A, B, C, D and E:

Placebo; orally, film-coated tablets, once daily, 8 weeks

Intervention Type DRUG

Other Intervention Names

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Lu 31-130 Lu 31-130 Lu 31-130 Lu 31-130 Lu 31-130

Eligibility Criteria

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Inclusion Criteria

* The patient has a primary diagnosis of schizophrenia
* The patient experiences clinically significant symptoms
* The patient did not experience an acute exacerbation requiring hospitalisation within the last 6 months
* The patient's medication has been stable for at least 4 weeks prior screening
* The subject has normal serum values of parameters associated with liver function
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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DE001

Munich, , Germany

Site Status

Countries

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Germany

Study Documents

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Document Type: EMA EudraCT Results

View Document

Other Identifiers

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EudraCT 2006-003739-57

Identifier Type: REGISTRY

Identifier Source: secondary_id

11613A

Identifier Type: -

Identifier Source: org_study_id