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Paliperidone Palmitate

Phase 3

Schizophrenia | Small molecule | Psychiatry |Alkermes plc|Last Updated: Aug 11, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Paliperidone Palmitate · 1 trial · 1 indication

Phase 3 1
NCT03345979A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of SchizophreniaSchizophrenia
COMPLETED200 Analytics
PHASE3COMPLETED
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Baseline and 4 weeks

Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.

Secondary Endpoints

Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Baseline and 4 weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Baseline and 9 weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Baseline and 25 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group 1EXPERIMENTALRegular injections
Treatment Group 2ACTIVE_COMPARATORRegular injections

Interventions

NameTypeDescription
Aripiprazole LauroxilCOMBINATION_PRODUCTIntramuscular injection; study drug provided using a pre-filled syringe
Paliperidone PalmitateDRUGIntramuscular injection
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Has a diagnosis of schizophrenia * Requires acute treatment for symptoms of schizophrenia * Willing and able to be confined to an inpatient study unit for up to 3-4 weeks * Has experienced at least one previous hospitalization for schizophrenia * Has been able to achieve outpa...

Countries:United States
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Frequently asked questions about Paliperidone Palmitate

What is Paliperidone Palmitate used for?

Paliperidone Palmitate is used for the treatment of schizophrenia. It is a small molecule being developed by Alkermes plc for this psychiatric condition. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for use.

Who makes Paliperidone Palmitate?

Paliperidone Palmitate is being developed by Alkermes plc, a biopharmaceutical company traded on the stock exchange under the ticker ALKS. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of schizophrenia.

What phase is Paliperidone Palmitate in?

Paliperidone Palmitate is in Phase 3 clinical development for schizophrenia. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, but the drug remains under clinical investigation.

What clinical trials is Paliperidone Palmitate in?

Paliperidone Palmitate was studied in a Phase 3 clinical trial with the identifier NCT03345979. This completed trial, titled 'A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia,' enrolled 200 participants in the United States. The study was randomized, double-blind, and active-controlled.

Is Paliperidone Palmitate the same as Aripiprazole Lauroxil?

No, Paliperidone Palmitate is not the same as Aripiprazole Lauroxil. They are different drugs that were compared in a clinical trial for the treatment of schizophrenia. The trial NCT03345979 evaluated both medications to assess their effects in patients with this condition.