A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
Sponsor
Alkermes, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03610048
Collaborator
(none)
175
34
1
20.7
5.1
0.2
Study Details
Study Description
Brief Summary
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
175 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 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder
Actual Study Start Date
:
Aug 9, 2018
Actual Primary Completion Date
:
May 1, 2020
Actual Study Completion Date
:
May 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ALKS 5461 Sublingual tablets |
Drug: ALKS 5461
samidorphan + buprenorphine administered sublingually
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) [Up to 68 weeks]
Number and percentage of subjects experiencing TEAEs
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 72 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Completed study ALK5461-217
-
Be willing to abide by the contraception requirements as outlined in the study protocol
-
Be willing and able to follow the study procedures and visits as outlined in the protocol
-
Additional criteria may apply
Exclusion Criteria:
-
Pregnant, planning to become pregnant, or breastfeeding
-
A positive urine drug test for drugs of abuse
-
Poses a current suicide risk
-
Additional criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alkermes Investigational Site | Tucson | Arizona | United States | 85712 |
| 2 | Alkermes Investigational Site | Little Rock | Arkansas | United States | 72211 |
| 3 | Alkermes Investigational Site | Los Alamitos | California | United States | 90720 |
| 4 | Alkermes Investigational Site | Oceanside | California | United States | 92054 |
| 5 | Alkermes Investigational Site | Pico Rivera | California | United States | 90660 |
| 6 | Alkermes Investigational Site | Redlands | California | United States | 92374 |
| 7 | Alkermes Investigational Site | Santa Ana | California | United States | 92705 |
| 8 | Alkermes Investigational Site | Sherman Oaks | California | United States | 91403 |
| 9 | Alkermes Investigational Site | Temecula | California | United States | 92591 |
| 10 | Alkermes Investigational Site | Hollywood | Florida | United States | 33024 |
| 11 | Alkermes Investigational Site | Jacksonville | Florida | United States | 32256 |
| 12 | Alkermes Investigational Site | Lauderhill | Florida | United States | 33319 |
| 13 | Alkermes Investigational Site | Orlando | Florida | United States | 32801 |
| 14 | Alkermes Investigational Site | Palm Bay | Florida | United States | 32905 |
| 15 | Alkermes Investigational Site | Atlanta | Georgia | United States | 30341 |
| 16 | Alkermes Investigational Site | Decatur | Georgia | United States | 30030 |
| 17 | Alkermes Investigational Site | Pikesville | Maryland | United States | 21208 |
| 18 | Alkermes Investigational Site | O'Fallon | Missouri | United States | 63368 |
| 19 | Alkermes Investigational Site | Jamaica | New York | United States | 11432 |
| 20 | Alkermes Investigational Site | Mount Kisco | New York | United States | 10549 |
| 21 | Alkermes Investigational Site | Canton | Ohio | United States | 44718 |
| 22 | Alkermes Investigational Site | Cincinnati | Ohio | United States | 45215 |
| 23 | Alkermes Investigational Site | Oklahoma City | Oklahoma | United States | 73112 |
| 24 | Alkermes Investigational Site | Allentown | Pennsylvania | United States | 18104 |
| 25 | Alkermes Investigational Site | Memphis | Tennessee | United States | 38119 |
| 26 | Alkermes Investigational Site | Dallas | Texas | United States | 75390 |
| 27 | Alkermes Investigational Site | DeSoto | Texas | United States | 75115 |
| 28 | Alkermes Investigational Site | Woodstock | Vermont | United States | 05091 |
| 29 | Alkermes Investigational Site | Bellevue | Washington | United States | 98007 |
| 30 | Alkermes Investigational Site | Frankston | Victoria | Australia | 3199 |
| 31 | Alkermes Investigational Site | Noble Park | Victoria | Australia | 3174 |
| 32 | Alkermes Investigational Site | Richmond | Victoria | Australia | 3121 |
| 33 | Alkermes Investigational Site | San Juan | Puerto Rico | 00918 | |
| 34 | Alkermes Investigational Site | San Juan | Puerto Rico | 00926 |
Sponsors and Collaborators
- Alkermes, Inc.
Investigators
- Study Director: Alkermes Medical Director, Alkermes, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT03610048
Other Study ID Numbers:
- ALK5461-218
First Posted:
Aug 1, 2018
Last Update Posted:
Jul 16, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alkermes, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects that had completed the 12-week treatment period in the antecedent study ALK5461-217 were eligible to be enrolled in the study. |
|---|---|
| Pre-assignment Detail | A total of 175 patients were administered at least one dose of ALKS 5461 and included in the safety population. |
| Arm/Group Title | ALKS 5461 |
|---|---|
| Arm/Group Description | All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually |
| Period Title: Overall Study | |
| STARTED | 175 |
| Completed Treatment | 15 |
| COMPLETED | 14 |
| NOT COMPLETED | 161 |
Baseline Characteristics
| Arm/Group Title | ALKS 5461 |
|---|---|
| Arm/Group Description | All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually |
| Overall Participants | 175 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
44.9
(12.87)
|
| Age, Customized (Count of Participants) | |
| <55 years |
127
72.6%
|
| >=55 years |
48
27.4%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
122
69.7%
|
| Male |
53
30.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
24
13.7%
|
| Not Hispanic or Latino |
151
86.3%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
4
2.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
19
10.9%
|
| White |
148
84.6%
|
| More than one race |
3
1.7%
|
| Unknown or Not Reported |
1
0.6%
|
| Region of Enrollment (participants) [Number] | |
| United States |
142
81.1%
|
| Australia |
23
13.1%
|
| Puerto Rico |
10
5.7%
|
Outcome Measures
| Title | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) |
|---|---|
| Description | Number and percentage of subjects experiencing TEAEs |
| Time Frame | Up to 68 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ALKS 5461 |
|---|---|
| Arm/Group Description | All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually |
| Measure Participants | 175 |
| Count of Participants [Participants] |
108
61.7%
|
Adverse Events
| Time Frame | 90 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | ALKS 5461 | |
| Arm/Group Description | All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually | |
All Cause Mortality |
||
| ALKS 5461 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/175 (0%) | |
Serious Adverse Events |
||
| ALKS 5461 | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/175 (2.3%) | |
| Gastrointestinal disorders | ||
| Vomiting | 1/175 (0.6%) | |
| Hepatobiliary disorders | ||
| Bile duct stone | 1/175 (0.6%) | |
| Infections and infestations | ||
| Gastroenteritis | 1/175 (0.6%) | |
| Musculoskeletal and connective tissue disorders | ||
| Osteoarthritis | 1/175 (0.6%) | |
Other (Not Including Serious) Adverse Events |
||
| ALKS 5461 | ||
| Affected / at Risk (%) | # Events | |
| Total | 85/175 (48.6%) | |
| Ear and labyrinth disorders | ||
| Vertigo | 4/175 (2.3%) | |
| Gastrointestinal disorders | ||
| Nausea | 36/175 (20.6%) | |
| Constipation | 17/175 (9.7%) | |
| Vomiting | 16/175 (9.1%) | |
| Dry mouth | 8/175 (4.6%) | |
| Abdominal pain upper | 4/175 (2.3%) | |
| General disorders | ||
| Fatigue | 6/175 (3.4%) | |
| Infections and infestations | ||
| Upper respiratory tract infection | 10/175 (5.7%) | |
| Urinary tract infection | 7/175 (4%) | |
| Nasopharyngitis | 5/175 (2.9%) | |
| Nervous system disorders | ||
| Dizziness | 21/175 (12%) | |
| Headache | 12/175 (6.9%) | |
| Sedation | 12/175 (6.9%) | |
| Somnolence | 9/175 (5.1%) | |
| Dysgeusia | 6/175 (3.4%) | |
| Psychiatric disorders | ||
| Insomnia | 7/175 (4%) | |
| Skin and subcutaneous tissue disorders | ||
| Hyperhidrosis | 6/175 (3.4%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Director, Corporate and R&D Communications |
|---|---|
| Organization | Alkermes |
| Phone | 781-609-7000 |
| Gretchen.Murphy@alkermes.com |
Responsible Party:
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT03610048
Other Study ID Numbers:
- ALK5461-218
First Posted:
Aug 1, 2018
Last Update Posted:
Jul 16, 2021
Last Verified:
Jun 1, 2021