Efficacy of Lu 31-130 in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00768326
First received: October 7, 2008
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Zicronapine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zicronapine. Study Part A Drug: Zicronapine

Study Part A:

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

Other Name: Lu 31-130
Experimental: Zicronapine. Study Part B Drug: Zicronapine

Study Part B:

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

Other Name: Lu 31-130
Experimental: Zicronapine. Study Part C Drug: Zicronapine

Study Part C:

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

Other Name: Lu 31-130
Experimental: Zicronapine. Study Part D Drug: Zicronapine

Study Part D:

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

Other Name: Lu 31-130
Experimental: Zicronapine. Study Part E Drug: Zicronapine

Study Part E:

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

Other Name: 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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768326

Locations
Germany
DE001
Munich, Germany, 80336
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00768326     History of Changes
Other Study ID Numbers: 11613A, EudraCT 2006-003739-57
Study First Received: October 7, 2008
Last Updated: September 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Indonesia: National Agency of Drug and Food Control
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: National Bureau of Controlled Drugs
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by H. Lundbeck A/S:
Schizophrenia
Antipsychotic
Lu 31-130

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014