SchizophreniaPhase 3NCT03345979

A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia

A Phase 3 study testing Aripiprazole Lauroxil and Paliperidone Palmitate in people with Schizophrenia, run by Alkermes, Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Aripiprazole Lauroxil and Paliperidone Palmitate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 16 sitesUnited States
Study dates: 15 Nov 2017to 12 Mar 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 outpatient status for more than 3 months in the past year
Has a body mass index (BMI) between 18.0 and 40.0 kg/m^2

Show all 9Show fewer

Resides in a stable living situation when not hospitalized
Has an identified reliable caregiver (for example, family member)
Additional criteria may apply

Who cannot join

Poses a current suicide risk
Pregnant, planning to become pregnant, or breastfeeding
Initiated first antipsychotic treatment within the past 12 months
Has received a long-acting injectable antipsychotic in the past 3 months
Has participated in a clinical study involving any investigational product within the past 3 months, or is currently participating in a clinical study involving an investigational product.
A positive urine drug test for drugs of abuse
Additional criteria may apply

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Alkermes Investigational Site
Austin, Texas, 78754
Alkermes Investigational Site
Berlin, New Jersey, 08009
Alkermes Investigational Site
Cerritos, California, 90703
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Culver City, California, 90230
Alkermes Investigational Site
Flowood, Mississippi, 39232
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Garland, Texas, 75042
Alkermes Investigational Site
Hialeah, Florida, 33012
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
Las Vegas, Nevada, 89102
Alkermes Investigational Site
Lemon Grove, California, 91945
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Richardson, Texas, 75080
Alkermes Investigational Site
Rogers, Arkansas, 72758
Alkermes Investigational Site
St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation

This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.

Conditions: Schizophrenia
Being tested: Aripiprazole Lauroxil, Paliperidone Palmitate
Keywords: Alkermes, schizophrenia, aripiprazole lauroxil, ARISTADA, ARISTADA INITIO
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aripiprazole LauroxilCombination product
Also called ARISTADA, ARISTADA INITIO
Intramuscular injection; study drug provided using a pre-filled syringe
Paliperidone PalmitateDrug
Also called Invega Sustenna
Intramuscular injection

Study groups in NCT03345979
Study group	Role	What they receive
Treatment Group 1	Experimental	Regular injections Receives: Combination Product: Aripiprazole Lauroxil
Treatment Group 2	Active comparator	Regular injections Receives: Drug: Paliperidone Palmitate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Least squares mean change in Positive and Negative Syndrome Scale (PANSS) between at 4 weeks from Mixed Models Repeated Measures (MMRM). 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
Measured: Baseline and 4 weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Change within treatment groups from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks 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.
Measured: Baseline and 9 weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Change within treatment groups at baseline Positive and Negative Syndrome Scale (PANSS) and at 25 weeks 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
Measured: Baseline and 25 weeks
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Least squares mean change from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks from Mixed Models Repeated Measures (MMRM).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
Measured: Baseline and 9 weeks
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Least squares mean change in Positive and Negative Syndrome Scale (PANSS) total score at week 25 from Mixed Models Repeated Measures. 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
Measured: Baseline and 25 weeks
Number of Participants With Serious and Non-serious Adverse Events (AEs)
Measured: Up to 25 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201712 Mar 2019

First posted17 Nov 2017
Study start15 Nov 2017
Primary completion12 Mar 2019
Study completion12 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03345979
Sponsor's protocol ID: ALK9072-A306
Status last verified: Jul 2020
First submitted: 14 Nov 2017
Last updated: 11 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Sommi RW, Saklad SR, Weiden PJ, Still D, Wang M, Yagoda S. Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. J Clin Psychiatry. 2024 Aug 12;85(3):23m15132. doi: 10.4088/JCP.23m15132.
PubMed 39145678
Citrome L, Yagoda S, Bidollari I, Wang M. Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized Controlled Trial. J Clin Psychiatry. 2024 Feb 28;85(1):23m15095. doi: 10.4088/JCP.23m15095.
PubMed 38416865
Nasrallah HA, Weiden PJ, Walling DP, Du Y, Yao B, Yagoda S, Claxton A. Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. BMC Psychiatry. 2021 Oct 8;21(1):492. doi: 10.1186/s12888-021-03420-x.
PubMed 34625041
Weiden PJ, Claxton A, Kunovac J, Walling DP, Du Y, Yao B, Yagoda S, Bidollari I, Keane E, Cash E. Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. J Clin Psychiatry. 2020 May 19;81(3):19m13207. doi: 10.4088/JCP.19m13207.
PubMed 32433835

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation
ClinicalTrials.gov ID: NCT03345979
Acronym / sponsor ID: ALK9072-A306
Conditions: Schizophrenia
Keywords: Alkermes, schizophrenia, aripiprazole lauroxil, ARISTADA, ARISTADA INITIO
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: 15 Nov 2017 (actual)
Primary completion: 12 Mar 2019 (actual)
Study completion: 12 Mar 2019 (actual)
First posted: 17 Nov 2017 (actual)
Results: Posted 11 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment Group 1	Experimental	Combination Product: Aripiprazole LauroxilRegular injections
Treatment Group 2	Active comparator	Drug: Paliperidone PalmitateRegular injections

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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 outpatient status for more than 3 months in the past year

Key exclusion criteria (7 listed)

Poses a current suicide risk
Pregnant, planning to become pregnant, or breastfeeding
Initiated first antipsychotic treatment within the past 12 months
Has received a long-acting injectable antipsychotic in the past 3 months
Has participated in a clinical study involving any investigational product within the past 3 months, or is currently participating in a clinical study involving an investigational product.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aripiprazole LauroxilAlso: ARISTADA, ARISTADA INITIOIntramuscular injection; study drug provided using a pre-filled syringe	Combination product	Treatment Group 1
Paliperidone PalmitateAlso: Invega SustennaIntramuscular injection	Drug	Treatment Group 2

Primary outcome

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Time frame: 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.

6 secondary outcomes

Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Time frame: Baseline and 4 weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Time frame: Baseline and 9 weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Time frame: Baseline and 25 weeks
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Time frame: Baseline and 9 weeks
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Time frame: Baseline and 25 weeks
Number of Participants With Serious and Non-serious Adverse Events (AEs)
Time frame: Up to 25 weeks

Results and safety

Results posted to the registry on 11 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole Lauroxil	99	56
Paliperidone Palmitate	101	43

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

Time frame: Baseline and 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Aripiprazole Lauroxil n = 80	Paliperidone Palmitate n = 80
Value	-17.4 (11.57)	-20.1 (13.72)

Aripiprazole Lauroxil: p <.001, t-test, 2 sided
Paliperidone Palmitate: p <.001, t-test, 2 sided

Population analysed: The analysis is based on the subjects who had both baseline and observed week 4 Positive and Negative Syndrome Scale (PANSS) data (160 participants).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over 25 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole Lauroxil	8 of 99 (8.1%)	39 of 99 (39.4%)	0 of 99
Paliperidone Palmitate	7 of 101 (6.9%)	50 of 101 (49.5%)	0 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39145678Sommi RW, Saklad SR, Weiden PJ, Still D, Wang M, Yagoda S. Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. J Clin Psychiatry. 2024 Aug 12;85(3):23m15132. doi: 10.4088/JCP.23m15132.
Derived from this study: PubMed 38416865Citrome L, Yagoda S, Bidollari I, Wang M. Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized Controlled Trial. J Clin Psychiatry. 2024 Feb 28;85(1):23m15095. doi: 10.4088/JCP.23m15095.
Derived from this study: PubMed 34625041Nasrallah HA, Weiden PJ, Walling DP, Du Y, Yao B, Yagoda S, Claxton A. Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. BMC Psychiatry. 2021 Oct 8;21(1):492. doi: 10.1186/s12888-021-03420-x.
Derived from this study: PubMed 32433835Weiden PJ, Claxton A, Kunovac J, Walling DP, Du Y, Yao B, Yagoda S, Bidollari I, Keane E, Cash E. Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. J Clin Psychiatry. 2020 May 19;81(3):19m13207. doi: 10.4088/JCP.19m13207.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sanjeev Pathak, MD study director

Alkermes, Inc.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole Lauroxil and Paliperidone Palmitate in people with Schizophrenia, run by Alkermes, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03345979, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.