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SchizophreniaPhase 2NCT00768326

Efficacy of Lu 31-130 in Patients With Schizophrenia

A Phase 2 study testing Zicronapine in people with Schizophrenia, run by H. Lundbeck A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Zicronapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
280 participants
Where
1 siteGermany
Study dates
Mar 2007to Nov 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • DE001

    Munich, 80336

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions
Schizophrenia
Being tested
Zicronapine, Placebo
Keywords
Schizophrenia, Antipsychotic, Lu 31-130
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZicronapineDrug

    Also called Lu 31-130

    Study Part A:

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

  • ZicronapineDrug

    Also called Lu 31-130

    Study Part B:

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

  • ZicronapineDrug

    Also called Lu 31-130

    Study Part C:

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

  • ZicronapineDrug

    Also called Lu 31-130

    Study Part D:

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

  • ZicronapineDrug

    Also called Lu 31-130

    Study Part E:

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

  • PlaceboDrug

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

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

Study groups in NCT00768326
Study groupRoleWhat they receive
Zicronapine. Study Part AExperimentalNot described
Receives: Drug: Zicronapine
Zicronapine. Study Part BExperimentalNot described
Receives: Drug: Zicronapine
Zicronapine. Study Part CExperimentalNot described
Receives: Drug: Zicronapine
Zicronapine. Study Part DExperimentalNot described
Receives: Drug: Zicronapine
Zicronapine. Study Part EExperimentalNot described
Receives: Drug: Zicronapine
2A, 2B, 2C, 2D, 2EPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8

Secondary outcomes (1)

  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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2008 (estimated)
  2. Study startMar 2007
  3. Primary completionOct 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00768326
Sponsor's protocol ID
11613A
Other IDs
EudraCT 2006-003739-57
Status last verified
Nov 2016
First submitted
7 Oct 2008
Last updated
8 Nov 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zicronapine in people with Schizophrenia, run by H. Lundbeck A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00768326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.

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