Efficacy of Lu 31-130 in Patients With Schizophrenia

A Double-blind, Randomised, Parallel-group, Placebo-controlled Study of the Safety, Tolerability and Efficacy Following Sequential Dose Regimens of Lu 31-130 to Patients With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Zicronapine; Drug: Zicronapine; Drug: Zicronapine; Drug: Zicronapine; Drug: Zicronapine; Drug: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80336
    • DE001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zicronapine. Study Part A	Drug: Zicronapine; Study Part A: 3mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part B: 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part C: 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part D: 2 x 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part E: 2 x 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130
Experimental: Zicronapine. Study Part B	Drug: Zicronapine; Study Part A: 3mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part B: 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part C: 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part D: 2 x 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part E: 2 x 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130
Experimental: Zicronapine. Study Part C	Drug: Zicronapine; Study Part A: 3mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part B: 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part C: 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part D: 2 x 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part E: 2 x 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130
Experimental: Zicronapine. Study Part D	Drug: Zicronapine; Study Part A: 3mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part B: 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part C: 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part D: 2 x 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part E: 2 x 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130
Experimental: Zicronapine. Study Part E	Drug: Zicronapine; Study Part A: 3mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part B: 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part C: 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part D: 2 x 5mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130; Drug: Zicronapine; Study Part E: 2 x 7mg; orally, film-coated tablets, once daily, 8 weeks; Other Names: Lu 31-130
Placebo Comparator: 2A, 2B, 2C, 2D, 2E	Drug: Placebo; Study Part A, B, C, D and E: Placebo; orally, film-coated tablets, once daily, 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Adverse events, clinical safety laboratory tests (including liver biochemistry tests), metabolic parameters (including blood lipids, blood glucose weight, waist circumference), abnormal movements	8

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy: Change in the Positive and Negative Syndrome Scale (PANSS) score from baseline to Week 8 as compared to placebo, change from baseline in Clinical Global Impression/Improvement (CGI-S/I) scores as compared to placebo	8 weeks

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 7, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 7, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Schizophrenia; Antipsychotic; Lu 31-130
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 11613A; EudraCT 2006-003739-57 (Registry Identifier: EudraCT)

Plan for Individual participant data (IPD)

Study Data/Documents

1. EMA EudraCT Results
   Information identifier: 2006-003739-57