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Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Sponsor
Alkermes, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03201757
Collaborator
(none)
500
Enrollment
86
Locations
1
Arm
77.5
Anticipated Duration (Months)
5.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Condition or Disease Intervention/Treatment Phase
  • Drug: ALKS 3831
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-labelOpen-label
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder
Actual Study Start Date :
Jun 15, 2017
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ALKS 3831

Coated bilayer tablet

Drug: ALKS 3831
Olanzapine + samidorphan, daily oral dosing

Outcome Measures

Primary Outcome Measures

  1. Safety will be measured by frequency of serious and non-serious adverse events [Up to 48 months]

Other Outcome Measures

  1. Change from baseline in body weight [Up to 48 months]

  2. Change from baseline in Clinical Global Impression-Severity (CGI-S) scale [Up to 48 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Willing and able to give informed consent/assent as per local requirements

  • Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal

  • Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator

  • Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307

  • Additional criteria may apply

Exclusion Criteria:

  • Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements

  • Has a positive drug screen for drugs of abuse at study entry

  • Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration

  • Additional criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alkermes Investigational Site Little Rock Arkansas United States 72211
2 Alkermes Investigational Site Rogers Arkansas United States 72758
3 Alkermes Investigational Site Anaheim California United States 92805
4 Alkermes Investigational Site Cerritos California United States 90703
5 Alkermes Investigational Site Culver City California United States 90230
6 Alkermes Investigational Site Garden Grove California United States 92845
7 Alkermes Investigational Site Glendale California United States 91206
8 Alkermes Investigational Site Long Beach California United States 90822
9 Alkermes Investigational Site Oakland California United States 94607
10 Alkermes Investigational Site Oceanside California United States 92056
11 Alkermes Investigational Site Orange California United States 92868
12 Alkermes Investigational Site Palo Alto California United States 94305
13 Alkermes Investigational Site Pico Rivera California United States 90660
14 Alkermes Investigational Site Redlands California United States 92374
15 Alkermes Investigational Site San Diego California United States 92013
16 Alkermes Investigational Site Temecula California United States 92591
17 Alkermes Investigational Site Torrance California United States 90502
18 Alkermes Investigational Site Lauderhill Florida United States 33319
19 Alkermes Investigational Site North Miami Florida United States 33161
20 Alkermes Investigational Site Atlanta Georgia United States 30303
21 Alkermes Investigational Site Atlanta Georgia United States 30329
22 Alkermes Investigational Site Atlanta Georgia United States 30331
23 Alkermes Investigational Site Augusta Georgia United States 30912
24 Alkermes Investigational Site Decatur Georgia United States 30030
25 Alkermes Investigational Site Chicago Illinois United States 60611
26 Alkermes Investigational Site Chicago Illinois United States 60640
27 Alkermes Investigational Site Winfield Illinois United States 60190
28 Alkermes Investigational Site Grand Rapids Michigan United States 49503
29 Alkermes Investigational Site Flowood Mississippi United States 39232
30 Alkermes Investigational Site Kansas City Missouri United States 64108
31 Alkermes Investigational Site Saint Louis Missouri United States 63110
32 Alkermes Investigational Site Saint Louis Missouri United States 63118
33 Alkermes Investigational Site Saint Louis Missouri United States 63128
34 Alkermes Investigational Site Saint Louis Missouri United States 63141
35 Alkermes Investigational Site Las Vegas Nevada United States 89102
36 Alkermes Investigational Site Berlin New Jersey United States 08009
37 Alkermes Investigational Site Marlton New Jersey United States 08053
38 Alkermes Investigational Site Brooklyn New York United States 11235
39 Alkermes Investigational Site Rochester New York United States 14615
40 Alkermes Investigational Site Canton Ohio United States 44718
41 Alkermes Investigational Site Cincinnati Ohio United States 45219
42 Alkermes Investigational Site Dayton Ohio United States 45417
43 Alkermes Investigational Site Eugene Oregon United States 97401
44 Alkermes Investigational Site Austin Texas United States 78759
45 Alkermes Investigational Site DeSoto Texas United States 75115
46 Alkermes Investigational Site Fort Worth Texas United States 76104
47 Alkermes Investigational Site Houston Texas United States 77030
48 Alkermes Investigational Site Richardson Texas United States 75080
49 Alkermes Investigational Site Bellevue Washington United States 98007
50 Alkermes Investigational Site Vienna Austria
51 Alkermes Investigational Site Burgas Bulgaria
52 Alkermes Investigational Site Lovech Bulgaria
53 Alkermes Investigational Site Novi Iskar Bulgaria
54 Alkermes Investigational Site Plovdiv Bulgaria
55 Alkermes Investigational Site Sofia Bulgaria
56 Alkermes Investigational Site Tserova Koria Bulgaria
57 Alkermes Investigational Site Veliko Tarnovo Bulgaria
58 Alkermes Investigational Site Vratsa Bulgaria
59 Alkermes Investigational Site Galway Ireland
60 Alkermes Investigational Site Jerusalem Israel
61 Alkermes Investigational Site Ramat Gan Israel
62 Alkermes Investigational Site Brescia Italy
63 Alkermes Investigational Site Napoli Italy
64 Alkermes Investigational Site Busan Korea, Republic of
65 Alkermes Investigational Site Poznań Poland
66 Alkermes Investigational Site San Juan Puerto Rico
67 Alkermes Investigational Site Arkhangel'sk Russian Federation
68 Alkermes Investigational Site Moscow Russian Federation
69 Alkermes Investigational Site Roshchino Russian Federation
70 Alkermes Investigational Site Rostov-on-Don Russian Federation
71 Alkermes Investigational Site Saint Petersburg Russian Federation
72 Alkermes Investigational Site Samara Russian Federation
73 Alkermes Investigational Site Saratow Russian Federation
74 Alkermes Investigational Site Tonnel'nyy Russian Federation
75 Alkermes Investigational Site Belgrade Serbia
76 Alkermes Investigational Site Belgrad Serbia
77 Alkermes Investigational Site Kragujevac Serbia
78 Alkermes Investigational Site Novi Kneževac Serbia
79 Alkermes Investigational Site Kharkiv Ukraine
80 Alkermes Investigational Site Kherson Ukraine
81 Alkermes Investigational Site Kyiv Ukraine
82 Alkermes Investigational Site Lviv Ukraine
83 Alkermes Investigational Site Poltava Ukraine
84 Alkermes Investigational Site Smila Ukraine
85 Alkermes Investigational Site Vinnytsia Ukraine
86 Alkermes Investigational Site Headington United Kingdom

Sponsors and Collaborators

  • Alkermes, Inc.

Investigators

  • Study Director: Alkermes Medical Director, Alkermes, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT03201757
Other Study ID Numbers:
  • ALK3831-A308
First Posted:
Jun 28, 2017
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alkermes, Inc.
Alkermes
ALKS 3831
Olanzapine
Samidorphan
Schizophrenia
Schizophreniform
Bipolar I
Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders

Study Results

No Results Posted as of Feb 11, 2022