A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia - R076477-SCH-302/702 (INT-1)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000326-70-CZ
• Date of registration: 29/06/2004
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag, Johnson & Johnson spol. s.r.o.
• Public title: A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia - R076477-SCH-302/702 (INT-1)
• Scientific title: A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia - R076477-SCH-302/702 (INT-1)
• Date of first enrolment: 11/08/2004
• Target sample size: 105
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000326-70
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: The optional 24 weeks extension protocol (R076477-SCH-702) is open label If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
The subjects must satisfy the following criteria to be enrolled in R076477-SCH-302:
· 65 years of age or older
· The subject signed an informed consent document indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study
· The subject signed an informed consent document indicating that the subject agrees or does not agree to participate in the pharmacogenomic portion of the study. A subject who does not agree to have a DNA sample collected is still eligible to participate in the main portion of the study
· DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
· Total PANSS score at screening and baseline (Visit 2) between 70 and 120, inclusive
· Agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated

The final visit of the double-blind treatment phase (Visit 10) will serve as the first visit of the open-label treatment phase (Visit 101) A subject must meet the following criteria to continue in the open-label treatment phase of the study (R076477-SCH-702):
·Subject has completed 6 weeks of the double-blind treatment phase or finished at least 21 days and discontinued because of lack of efficacy
· Subject has signed the informed consent form for the open-label treatment phase
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
· A DSM-IV Axis I diagnosis other than schizophrenia
· A DSM-IV diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
· Any medical condition that can potentially alter the absorption, metabolism, or excretion of the study drug such as Crohn’s disease, liver disease, or renal disease
· Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases
· History of tardive dyskinesia or neuroleptic malignant syndrome (NMS)· Known allergic reaction (rash) to phenytoin, carbamazepine, barbiturates, lamotrigine
· Other significant and/or unstable systemic illnesses
· Allergy or hypersensitivity to risperidone or paliperidone
· History of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
· Inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
· Previous history of a lack of response (2 adequate trials) to any antipsychotic
· Exposure to an experimental drug or experimental medical device within 90 days before screening
· Significant risk of suicidal or violent behavior
· Alanine aminotransferase or aspartate aminotransferase levels more than 2 times the upper limit of normal
· Other biochemistry, hematology, or urinalysis results that are not within the laboratory’s reference range, and that are deemed by the investigator to be clinically significant


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Product Name: paliperidone 3 mg overencapsulated tablets
Product Code: F022
Pharmaceutical Form: Tablet
INN or Proposed INN: paliperidone
CAS Number: 144598-75-4
Current Sponsor code: JNJ16232411, R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: paliperidone 9 mg overencapsulated tablets
Product Code: F023
Pharmaceutical Form: Tablet
INN or Proposed INN: paliperidone
CAS Number: 144598-75-4
Current Sponsor code: JNJ16232411, R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: paliperidone 3 mg tablets
Product Code: F016
Pharmaceutical Form: Tablet
INN or Proposed INN: paliperidone
CAS Number: 144598-75-4
Current Sponsor code: JNJ16232411, R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Product Name: paliperidone 9 mg tablets
Product Code: F0017
Pharmaceutical Form: Tablet
INN or Proposed INN: paliperidone
CAS Number: 144598-75-4
Current Sponsor code: JNJ16232411, R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-

Primary Outcome(s)

Primary end point(s): The primary objective of the study is to evaluate safety and tolerability. This will be done through Adverse events listing and summarization. Clinical laboratory data and changes from baseline will be summarized. Changes noted in physical examinations, ECGs, and SAS, BARS, and AIMS will be summarized.

Secondary Objective: · Assess the global improvement in severity of illness associated with the use of ER OROS paliperidone compared with placebo
· Evaluate the benefits to the vitality and psychosocial domains of quality of life associated with the use of ER OROS paliperidone compared with placebo
· Assess the benefits to personal and social functioning associated with the use of ER OROS paliperidone compared with placebo
· Evaluate the improvement to sleep associated with the use of ER OROS paliperidone compared with placebo
· Explore the pharmacokinetics of ER OROS paliperidone and the relationship between pharmacokinetics and efficacy parameters, such as PANSS, and safety parameters of interest, such as extrapyramidal symptoms and other adverse events
· Determine genes/genotypes that may be related to the response to or metabolism of ER OROS paliperidone.

Main Objective: The primary objective of the study is to evaluate the safety and tolerability of flexible doses of Extended Release (ER) OROS® paliperidone (3 to 12 mg/day) as compared with placebo in subjects with schizophrenia who are 65 years of age or older.
The primary objective of the open-label extension is the long-term assessment of safety and tolerability of ER OROS paliperidone (3 to 12 mg/day) in subjects diagnosed with schizophrenia.

Secondary ID(s)

R076477-SCH-302/702