A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03893825

Collaborator

(none)

336

Enrollment

Locations

Arms

32.1

Actual Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new patients, the total duration of patient participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage [Stage 1], a 56-week double-blind maintenance stage [Stage 2], and a follow-up period [8 weeks]). For roll-over patients, the total duration of patient participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage [Stage 2] and a follow-up period [8 weeks]). Patients who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Patients who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, patients will be treated according to the investigator's judgment.

All subjects will be treated with active drug.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: TV-46000 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Study to Evaluate the Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Dec 2, 2021

Actual Study Completion Date :

Dec 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TV-46000 - A Dose regimen A	Drug: TV-46000 subcutaneous (sc) injection
Experimental: TV-46000 - B Dose regimen B	Drug: TV-46000 subcutaneous (sc) injection Drug: Placebo Matching Placebo

Arm

Intervention/Treatment

Experimental: TV-46000 - A

Dose regimen A

Drug: TV-46000

subcutaneous (sc) injection

Experimental: TV-46000 - B

Dose regimen B

Drug: TV-46000

subcutaneous (sc) injection

Drug: Placebo

Matching Placebo

Outcome Measures

Primary Outcome Measures

Number of adverse events including serious adverse events [Week 56]

Other Outcome Measures

Number of participants who withdraw due to adverse events [Week 56]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072:

The patient must have participated in the pivotal efficacy study (Study TV46000-CNS-30072) without experiencing relapse events and without important protocol deviations.
If the patient was taking antidepressants or mood stabilizers in Study TV46000-CNS-30072, no dose changes or initiation of treatment with these medications will be permitted.
The patient, in the investigator's judgment, requires chronic treatment with an antipsychotic medication.
The patient is able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens (oral and sc administration) and non-use of prohibited concomitant medications; can read and understand the written word in order to complete patient-reported outcomes measures; and can be reliably rated on assessment scales.
The patient has had a stable place of residence for the previous 3 months before the baseline visit in this study, and changes in residence are not anticipated over the course of study participation.
The patient has no significant life events (such as pending loss of housing, family status change, long travel abroad, surgery, etc) that could affect study outcomes expected throughout the period of study participation.
Women of childbearing potential and sexually active female adolescents must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception and agree to continue use of this method beginning 1 month before the first administration of study drug and for the duration of the study and for 120 days after the last injection of study drug.
The patient, if adult or adolescent male, is surgically sterile, or, if capable of producing offspring, has exclusively same-sex partners or is currently using an approved method of birth control and agrees to the continued use of this method for the duration of the study (and for 120 days after the last dose of study drug). Male patients with sex partners who are women of childbearing potential must use condoms even if surgically sterile. In addition, male patients may not donate sperm for the duration of the study and for 120 days after taking the study drug.

New Patients (Not Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072):

The patient has a diagnosis of schizophrenia
The patient has been responsive to an antipsychotic treatment (other than clozapine) in the past year based on investigator judgment (and discussions with family members, caregivers, or healthcare professionals as applicable).
The patient, in the investigator's judgment, requires chronic treatment with an antipsychotic medication.
The patient is able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens (oral and sc administration) and non-use of prohibited concomitant medications; can read and understand the written word in order to complete patient-reported outcomes measures; and can be reliably rated on assessment scales.
The patient has had a stable place of residence for the previous 3 months before screening, and changes in residence are not anticipated over the course of study participation.
The patient has no significant life events (such as pending loss of housing, family status change, long travel abroad, surgery, etc) that could affect study outcomes expected throughout the period of study participation.
The patient has a body mass index between 18.0 and 38.0 kg/m2, inclusive.
Women of childbearing potential and sexually active female adolescents must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception and agree to continue use of this method beginning 1 month before the first administration of study drug and for the duration of the study and for 120 days after the last injection of study drug.
The patient, if adult or adolescent male, is surgically sterile, or, if capable of producing offspring, has exclusively same-sex partners or is currently using an approved method of birth control and agrees to the continued use of this method for the duration of the study (and for 120 days after the last dose of study drug). Male patients with sex partners who are women of childbearing potential must use condoms even if surgically sterile. In addition, male patients may not donate sperm for the duration of the study and for 120 days after taking the study drug.
Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

Patients Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072:

The patient has a finding in the baseline 12-lead ECG that is considered clinically significant in the judgment of the investigator.
Poor compliance with study procedures (in the opinion of the investigator or sponsor) during the pivotal efficacy Study TV46000-CNS-30072. This should be discussed on a case-by-case basis.

New Patients (Not Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072) and

Roll-Over Patients:

The patient is currently on clozapine or has received electroconvulsive therapy in the last 12 months.
The patient has a history of epilepsy or seizures, neuroleptic malignant syndrome, tardive dyskinesia, or other medical condition that would expose the patient to undue risk.
The patient has a positive serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B surface antigen, and/or hepatitis C.
The patient has current or a history of known hypersensitivity to risperidone or any of the excipients of TV-46000 or the oral formulation of risperidone used in the stabilization phase.
The patient has a substance use disorder, including alcohol and benzodiazepines but excluding nicotine and caffeine.
The patient is a pregnant or lactating female.
The patient has used an investigational drug other than TV-46000 within 3 months prior to screening or has participated in a non-drug clinical trial within 30 days prior to screening.
Vulnerable patients (eg, people kept in detention).
Additional criteria apply, please contact the investigator for more information.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teva Investigational Site 14391	Phoenix	Arizona	United States	85012
2	Teva Investigational Site 14401	Scottsdale	Arizona	United States	85258
3	Teva Investigational Site 14405	Tucson	Arizona	United States	85719
4	Teva Investigational Site 14796	Rogers	Arkansas	United States	72758
5	Teva Investigational Site 14811	Anaheim	California	United States	92805
6	Teva Investigational Site 14794	Bellflower	California	United States	90706
7	Teva Investigational Site 14776	Colton	California	United States	92324
8	Teva Investigational Site 14802	Costa Mesa	California	United States	92627
9	Teva Investigational Site 14773	Culver City	California	United States	90230
10	Teva Investigational Site 14774	Glendale	California	United States	91206
11	Teva Investigational Site 14817	La Habra	California	United States	90631
12	Teva Investigational Site 14771	Lemon Grove	California	United States	91945
13	Teva Investigational Site 14863	Long Beach	California	United States	90807
14	Teva Investigational Site 14816	Montclair	California	United States	91763
15	Teva Investigational Site 14786	Oakland	California	United States	94607
16	Teva Investigational Site 14827	Oceanside	California	United States	92056-4515
17	Teva Investigational Site 14777	Orange	California	United States	92868
18	Teva Investigational Site 14815	Pico Rivera	California	United States	90660
19	Teva Investigational Site 14785	San Bernardino	California	United States	92408
20	Teva Investigational Site 14818	San Diego	California	United States	92103
21	Teva Investigational Site 14788	Torrance	California	United States	90502
22	Teva Investigational Site 14783	Coral Gables	Florida	United States	33134
23	Teva Investigational Site 14865	Hialeah	Florida	United States	33012
24	Teva Investigational Site 14787	Hialeah	Florida	United States	33016
25	Teva Investigational Site 14814	Hialeah	Florida	United States	33018
26	Teva Investigational Site 14861	Homestead	Florida	United States	33030
27	Teva Investigational Site 14390	Lake Mary	Florida	United States	32746
28	Teva Investigational Site 14799	Lauderhill	Florida	United States	33319
29	Teva Investigational Site 14389	Maitland	Florida	United States	32751
30	Teva Investigational Site 14875	Miami	Florida	United States	33122
31	Teva Investigational Site 14400	Miami	Florida	United States	33125
32	Teva Investigational Site 14832	Miami	Florida	United States	33126
33	Teva Investigational Site 14810	North Miami	Florida	United States	33161
34	Teva Investigational Site 14860	Tampa	Florida	United States	33613
35	Teva Investigational Site 14396	W. Miami	Florida	United States	33144
36	Teva Investigational Site 14821	Decatur	Georgia	United States	30030
37	Teva Investigational Site 14770	Marietta	Georgia	United States	30060
38	Teva Investigational Site 14415	Norcross	Georgia	United States	30093
39	Teva Investigational Site 14829	Chicago	Illinois	United States	60640
40	Teva Investigational Site 14805	Hoffman Estates	Illinois	United States	60169
41	Teva Investigational Site 14871	Lincolnwood	Illinois	United States	60712
42	Teva Investigational Site 14862	Lake Charles	Louisiana	United States	70629
43	Teva Investigational Site 14869	Monroe	Louisiana	United States	71201
44	Teva Investigational Site 14866	Gaithersburg	Maryland	United States	20877
45	Teva Investigational Site 14764	Glen Burnie	Maryland	United States	21061
46	Teva Investigational Site 14791	Saint Louis	Missouri	United States	63109
47	Teva Investigational Site 14813	Saint Louis	Missouri	United States	63128
48	Teva Investigational Site 14826	Saint Louis	Missouri	United States	63132
49	Teva Investigational Site 14809	Las Vegas	Nevada	United States	89102
50	Teva Investigational Site 14414	Las Vegas	Nevada	United States	89109
51	Teva Investigational Site 14792	Berlin	New Jersey	United States	08009
52	Teva Investigational Site 14772	Cedarhurst	New York	United States	11516
53	Teva Investigational Site 14876	New York	New York	United States	10036
54	Teva Investigational Site 14780	Staten Island	New York	United States	10312
55	Teva Investigational Site 14867	Hickory	North Carolina	United States	28601
56	Teva Investigational Site 14416	Beachwood	Ohio	United States	44122
57	Teva Investigational Site 14763	Cincinnati	Ohio	United States	45219
58	Teva Investigational Site 14782	Dayton	Ohio	United States	45417
59	Teva Investigational Site 14859	Garfield Heights	Ohio	United States	44125
60	Teva Investigational Site 14793	Media	Pennsylvania	United States	19063
61	Teva Investigational Site 14778	Charleston	South Carolina	United States	29407
62	Teva Investigational Site 14868	Memphis	Tennessee	United States	38119
63	Teva Investigational Site 14801	Houston	Texas	United States	77081
64	Teva Investigational Site 14807	Irving	Texas	United States	75062
65	Teva Investigational Site 14393	Plano	Texas	United States	75093
66	Teva Investigational Site 14856	Richardson	Texas	United States	75080
67	Teva Investigational Site 14395	Bellevue	Washington	United States	98007
68	Teva Investigational Site 59148	Bourgas		Bulgaria	8000
69	Teva Investigational Site 59152	Kazanlak		Bulgaria	6100
70	Teva Investigational Site 59151	Lovech		Bulgaria	5500
71	Teva Investigational Site 59149	Novi Iskar		Bulgaria	1282
72	Teva Investigational Site 59144	Sofia		Bulgaria	1680
73	Teva Investigational Site 59154	Varna		Bulgaria	9000
74	Teva Investigational Site 59150	Varna		Bulgaria	9020
75	Teva Investigational Site 59146	Vratsa		Bulgaria	3000
76	Teva Investigational Site 11171	Calgary	Alberta	Canada	T2N 4Z6
77	Teva Investigational Site 11169	Edmonton	Alberta	Canada	T5J 2J7
78	Teva Investigational Site 11173	Vancouver	British Columbia	Canada	V6Z 2L4
79	Teva Investigational Site 11170	Chatham	Ontario	Canada	N7L 1C1
80	Teva Investigational Site 11174	Montreal	Quebec	Canada	H1N 3M5
81	Teva Investigational Site 35259	Clermont Ferrand Cedex 1		France	63003
82	Teva Investigational Site 35257	Douai		France	59500
83	Teva Investigational Site 35260	Nice cedex 1		France	6002
84	Teva Investigational Site 35256	Toulon		France	83000
85	Teva Investigational Site 80162	Afula		Israel	1834111
86	Teva Investigational Site 80161	Ashkelon		Israel	7830604
87	Teva Investigational Site 80156	Haifa		Israel	31096
88	Teva Investigational Site 80155	Hod Hasharon		Israel	4534708
89	Teva Investigational Site 80157	Ramat Gan		Israel	5262160
90	Teva Investigational Site 80160	Tel Aviv		Israel	6423906

Sponsors and Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Teva Branded Pharmaceutical Products R&D, Inc.

ClinicalTrials.gov Identifier:

NCT03893825

Other Study ID Numbers:

TV46000-CNS-30078
2019-000063-24

First Posted:

Mar 28, 2019

Last Update Posted:

Feb 8, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Feb 8, 2022