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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00810667
Other study ID # 12450A
Secondary ID 2008-001441-26
Status Completed
Phase Phase 2
First received December 17, 2008
Last updated November 7, 2016
Start date November 2008
Est. completion date February 2010

Study information

Verified date November 2016
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hong Kong: Department of HealthItaly: The Italian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsTaiwan: Department of HealthThailand: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this study is to explore the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia.


Description:

Lu AE58054 is a selective 5-HT6 antagonist that is currently being investigated for treatment of conditions of cognitive impairment associated with schizophrenia. Substantial experimental evidence suggests that selective 5-HT6 receptor antagonists may be effective in treating cognitive deficits since they have been shown to improve performance in various animal models of cognitive function and are known to enhance cholinergic and glutaminergic neuronal function.

Lu AE58054 has been investigated in healthy volunteers and patients with schizophrenia, is generally well tolerated and has a benign side-effect profile. Moreover, no safety concerns or issues have been identified to date.

The study is designed to provide data on the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia. Efficacy will be assessed in patients who are in a stable phase of their illness, but with a predefined minimum and maximum level of symptoms that will allow them to be included in the study. Patients will be randomly assigned to receive either the investigational medicinal product (IMP) or placebo as add-on therapy to their existing risperidone treatment.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date February 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Primary diagnosis of schizophrenia

- Man or woman, aged between 18-65

- Patient is on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening

- The patient has a PANSS total score between 70 and 100 (extremes included) at screening

Exclusion Criteria:

- Primary psychiatric diagnosis other than schizophrenia

- Acute exacerbation requiring hospitalisation within the last 3 months

- Clinically significant extrapyramidal symptoms

- Clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia

- Significant ECG abnormalities

- In concurrent treatment with drugs inhibiting the P450 enzymes system CYP2D6 and other CYP Isozymes

- Failed to respond to adequate courses of treatment with risperidone

- Treated with an antipsychotic other than risperidone within 4 weeks prior to screening

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Lu AE58054
twice daily oral dose (60 mg BID: total dose 120 mg/day)
Placebo
twice daily oral dose

Locations

Country Name City State
Belgium BE001 Liege
Belgium BE005 Liege
France FR002 Bordeaux
France FR003 Brumath
France FR001 Nimes
France FR006 Toulouse
Germany DE002 Dresden
Hong Kong HK001 Hong Kong
Italy IT003 Brescia
Italy IT004 Napoli
Poland PL009 Belchatow
Poland PL006 Bialystok
Poland PL002 Leszno
Poland PL012 Lodz
Poland PL001 Lublin
Poland PL003 Lublin
Poland PL010 Piekary Slaskie
Poland PL004 Skorzewo
Poland PL008 Torun
Poland PL011 Warszawa
Poland PL007 Wrzesnia
Taiwan TW001 Hualien
Taiwan TW003 Keelung
Taiwan TW004 Tainan
Thailand TH002 Chiang Mai

Sponsors (1)

Lead Sponsor Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hong Kong,  Italy,  Poland,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy effect of treatment based on the PANSS total score 12 weeks No
Secondary PANSS subscales scores, CGI-S and CGI-I scores, CDSS scores, S-QoL scores, BACS, Abnormal movement scales (AIMS, BARS, SAS), ECGs, serum prolactin, pharmacokinetic assessments 12 weeks Yes
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