PALMFLEXS: A 6 month study into transition to paliperidone palmitate

• Research type

  Research Study

• Full 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

• IRAS ID

  52674

• Contact name

  Domingo Gonzalez

• Sponsor organisation

  Janssen Cilag International N.V.

• Eudract number

  2009-018022-30

• ISRCTN Number

  N/A

• Research summary

  Paliperidone palmitate, a treatment for schizophrenia, has undergone extensive clinical trials and was approved in the US on 31 July 2009. Previous studies have used strict criteria to limit variation within the subjects taking part. The current study will evaluate paliperidone palmitate in a more diverse population of subjects with schizophrenia, reflecting patients treated in normal day-to-day practice. This study is international, multicentre and will enrol approximately 1000 subjects with schizophrenia, unsuccessfully treated with a previous antipsychotic medication. Each subject will receive an injection of paliperidone palmitate on Day 1, Day 8 (for subjects transitioning from oral antipsychotics only) and monthly thereafter for 6 months. The tolerability, safety and treatment response of flexibly dosed paliperidone palmitate will be assessed. Subjects who successfully complete the 6-month treatment phase and would like to continue treatment may be enrolled in an extension phase until paliperidone palmitate is available in their respective country or until a maximum duration of 12 months (per subject), whichever comes first.Patients will switch from their current treatment of different oral or long-acting injectable antipsychotics (LAI) to paliperidone palmitate. The dosage of paliperidone palmitate can be individually adjusted for each subject at the discretion of the investigator.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/88

• Date of REC Opinion

  12 Oct 2010

• REC opinion

  Favourable Opinion