Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    Lu-31-130

Efficacy of Lu 31-130 in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00768326
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE October 7, 2008
First Posted Date  ICMJE October 8, 2008
Last Update Posted Date November 8, 2016
Study Start Date  ICMJE March 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2008)
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 ]
Change History Complete list of historical versions of study NCT00768326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Lu 31-130 in Patients With Schizophrenia
Official Title  ICMJE 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
Brief Summary 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

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  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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

Study Arms
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2009)
280
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2008)
210
Actual Study Completion Date November 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00768326
Other Study ID Numbers  ICMJE 11613A
EudraCT 2006-003739-57 ( Registry Identifier: EudraCT )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date November 2016

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