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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: March 26, 2013
Last verified: March 2013
History of Changes

October 7, 2008
March 26, 2013
March 2007
October 2009   (final data collection date for primary outcome measure)
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 ]
Safety: Adverse events, clinical safety laboratory tests (including liver biochemistry tests), metabolic parameters (includiing blood lipids, blood glucose weight, waist circumference), abnormal movements [ Time Frame: 8 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00768326 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Zicronapine

    Study Part A:

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

    Other Name: Lu 31-130
  • Drug: Zicronapine

    Study Part B:

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

    Other Name: Lu 31-130
  • Drug: Zicronapine

    Study Part C:

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

    Other Name: Lu 31-130
  • Drug: Zicronapine

    Study Part D:

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

    Other Name: Lu 31-130
  • Drug: Zicronapine

    Study Part E:

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

    Other Name: Lu 31-130
  • Drug: Placebo

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

    Placebo; orally, film-coated tablets, once daily, 8 weeks
  • Experimental: Zicronapine. Study Part A
    Intervention: Drug: Zicronapine
  • Experimental: Zicronapine. Study Part B
    Intervention: Drug: Zicronapine
  • Experimental: Zicronapine. Study Part C
    Intervention: Drug: Zicronapine
  • Experimental: Zicronapine. Study Part D
    Intervention: Drug: Zicronapine
  • Experimental: Zicronapine. Study Part E
    Intervention: Drug: Zicronapine
  • Placebo Comparator: 2A, 2B, 2C, 2D, 2E
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
November 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00768326
11613A, EudraCT 2006-003739-57
Yes
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP