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Completed

NCT Number: NCT00768326

Efficacy of Lu 31-130 in 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

DE001

Munich, 80336, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zicronapine

Drug

Study Part A:

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

Other names: Lu 31-130

Placebo

Drug

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

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

Primary outcomes

  1. Safety: Adverse events, clinical safety laboratory tests (including liver biochemistry tests), metabolic parameters (including blood lipids, blood glucose weight, waist circumference), abnormal movements

    Time frame: 8

Secondary outcomes

  1. 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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2008
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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