Paliperidone Palmitate Flexible Dosing in Schizophrenia (PALMFlexS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01281527
First received: January 20, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone Palmitate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 6-month, Open Label, Prospective, Multicenter, International, Exploratory Study of a Transition to Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated With Oral or Long-acting Injectable Antipsychotics

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • Improved efficacy for non-acute patients transitioned due to lack of efficacy, as measured by the total PANSS score at endpoint versus baseline. [ Time Frame: Baseline to 6 months or early discontinuation ] [ Designated as safety issue: No ]
  • Improved efficacy for acute patients, as measured by the total PANSS score at endpoint versus baseline. [ Time Frame: Baseline to 6 months or early discontinuation ] [ Designated as safety issue: No ]
  • Maintained efficacy for non-acute patients transitioned for other reasons based on PANSS score at endpoint versus baseline. [ Time Frame: Baseline to 6 months or early discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Clinical Global Impression-Severity Scale [CGI-S] [ Time Frame: Baseline, week 1, month 1, 2, 3 and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in personal and social functioning (Personal and Social Performance Scale [PSP]) [ Time Frame: Baseline, week 1, month 1, 2, 3 and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in Health status (Self-reported health status questionnaire [SF-36]) [ Time Frame: Baseline, month 3 and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in Measure of Health Outcome (EQ-5D) [ Time Frame: Baseline, month 3 and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in Patient well-being (Subjective Well-Being under Neuroleptics Scale [SWN-S]); [ Time Frame: Baseline, month 3 and 6 ] [ Designated as safety issue: No ]

Enrollment: 1044
Study Start Date: November 2010
Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone Palmitate
Paliperidone Palmitate 50 - 150 mg eq. every 30 days for 6 months during the core phase and for 12 months during an optional extension phase after the last patient has completed the 6-month core treatment phase or until product will be available on market (whichever comes first)
Drug: Paliperidone Palmitate
50 - 150 mg eq. every 30 days

Detailed Description:

This study explores the tolerability, safety and treatment response of flexibly dosed paliperidone palmitate in approximately 1,000 patients with schizophrenia previously unsuccessfully treated with an oral or LAI antipsychotic medication. Non-acute and acute patients will be involved in the study. This study consists of a screening phase, a 6-month core treatment phase, and an optional extension phase. A transition period of preferably a maximum of 4 weeks will be allowed for the previous oral antipsychotic. When switching patients from previous LAI antipsychotics, paliperidone palmitate will be initiated in place of the next scheduled injection. Patients without source documentation of previous risperidone or paliperidone exposure must undergo oral tolerability testing with paliperidone ER (3 mg/day) for the 2 days prior to Baseline Visit. Patients who successfully complete the 6-month core treatment phase and would like to continue treatment with paliperidone palmitate may be enrolled in an optional extension phase until paliperidone palmitate is available in their respective country or until a maximum duration of 12 months after the last subject has completed the 6-month core treatment phase, whichever comes first. Patients will receive, without cost, paliperidone palmitate. Patients entering this optional extension phase, will receive once monthly injections with paliperidone palmitate. The recommended maintenance dose for these monthly injections is 75 mg eq. once monthly but flexible dosing in the range of 50 to 150 mg eq. once monthly will be allowed. The doctor may flexibly increase or decrease the dose preferably by one dosing level (within the range of 50 to 150 mg eq.) according to patients' clinical needs. During the extension phase, two types of visits can be distinguished: 'assessment visits' and 'treatment-only visits'. At each assessment visit (once every 3 months +/- 7 days), patients will receive their injection and will be questioned about adverse events (AEs). Body weight will also be assessed. Paliperidone palmitate will be given once monthly by injection in either the upper arm or buttocks muscle, but start every time with upper arm application. The recommended maintenance dose for these monthly injections is 75 mg eq., range could be between 50 to 150 mg eq.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Meet the DSM-IV criteria for schizophrenia Currently non-acute, i.e., on the same antipsychotic medication used for the treatment of schizophrenia given in an adequate dose and a CGI-S change <= 1 in the past 4 weeks before enrollment Patient has been given an adequate dose of either an appropriate oral antipsychotic, or a protocol-defined LAI antipsychotic for an adequate period of time prior to enrollment, but current treatment is considered unsuccessful OR Patients with acute symptoms of schizophrenia, previously treated with an oral antipsychotic, having a baseline total Positive and Negative Syndrome Scale (PANSS) score >= 80 and a baseline CGI-S score >= 4 Women must be postmenopausal for at least 1 year, surgically sterile, abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing a highly effective method of birth control as local regulations permit, and before entry, must agree to continue to use the same method of contraception throughout the study Is cooperative and reliable, and agrees to receive regular injections and complete all aspects of the protocol Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.

Exclusion Criteria:

The patient's psychiatric diagnosis is due to direct pharmacological effects of a substance (e.g., a drug of abuse or medication) or a general medical condition (e.g., clinically notable hypothyroidism) First antipsychotic treatment ever, i.e., patient has never been treated with antipsychotics before and antipsychotic treatment given in this study will be the first antipsychotic treatment that the patient will have ever received On clozapine during the last 3 months Patients who remain at imminent risk of suicide even after clinical intervention Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281527

  Show 129 Study Locations
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01281527     History of Changes
Other Study ID Numbers: CR017215, R092670SCH3010
Study First Received: January 20, 2011
Last Updated: March 6, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Turkey: Ethics Committee

Keywords provided by Janssen-Cilag International NV:
Paliperidone palmitate
Schizophrenia
Intramuscular injection

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014