Trial Outcomes & Findings for Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (NCT NCT03201757)
NCT ID: NCT03201757
Last Updated: 2024-09-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
523 participants
Primary outcome timeframe
Up to 48 months
Results posted on
2024-09-26
Participant Flow
Participant milestones
| Measure |
ALKS 3831
Coated bilayer tablet
ALKS 3831: Olanzapine + samidorphan, daily oral dosing ranging from 5/10, 10/10, 15/10, and 20/10 mg at the Investigator's discretion.
|
|---|---|
|
Overall Study
STARTED
|
523
|
|
Overall Study
COMPLETED
|
188
|
|
Overall Study
NOT COMPLETED
|
335
|
Reasons for withdrawal
| Measure |
ALKS 3831
Coated bilayer tablet
ALKS 3831: Olanzapine + samidorphan, daily oral dosing ranging from 5/10, 10/10, 15/10, and 20/10 mg at the Investigator's discretion.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
133
|
|
Overall Study
Adverse Event
|
44
|
|
Overall Study
Lost to Follow-up
|
37
|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Protocol Violation
|
20
|
|
Overall Study
Study Terminated at Site by Sponsor Due to Regional War
|
1
|
|
Overall Study
Not Yet Determined
|
5
|
|
Overall Study
Logistical Difficulties Due to Regional Wars & COVID-19
|
72
|
|
Overall Study
Other
|
20
|
Baseline Characteristics
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
Baseline characteristics by cohort
| Measure |
ALKS 3831
n=523 Participants
Coated bilayer tablet
ALKS 3831: Olanzapine + samidorphan, daily oral dosing
|
|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
322 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
504 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
380 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
206 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
118 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
69 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
25 participants
n=5 Participants
|
|
Height
|
172.28 Centimeters
STANDARD_DEVIATION 9.481 • n=5 Participants
|
|
Weight
|
77.39 kilograms
STANDARD_DEVIATION 15.486 • n=5 Participants
|
|
Body Mass Index
|
26.00 kg/m^2
STANDARD_DEVIATION 4.332 • n=5 Participants
|
|
Clinical Global Impression-Severity
|
3.06 units on a scale
STANDARD_DEVIATION .867 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: All enrolled participants who received at least 1 dose of study drug
Outcome measures
| Measure |
ALKS 3831
n=523 Participants
Coated bilayer tablet
ALKS 3831: Olanzapine + samidorphan, daily oral dosing
|
|---|---|
|
Incidence of Adverse Events
|
314 Participants
|
PRIMARY outcome
Timeframe: Up to 48 monthsThe clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients
Outcome measures
| Measure |
ALKS 3831
n=523 Participants
Coated bilayer tablet
ALKS 3831: Olanzapine + samidorphan, daily oral dosing
|
|---|---|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
|
-.24 units on a scale
Standard Deviation .651
|
Adverse Events
ALKS 3831
Serious events: 35 serious events
Other events: 314 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ALKS 3831
n=523 participants at risk
Coated bilayer tablet
ALKS 3831: Olanzapine + samidorphan, daily oral dosing
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Cardiac disorders
Aortic valve incompetence
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Crohn's disease
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Haematochezia
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Immune system disorders
Anaphylactic shock
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Infections and infestations
Appendicitis
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Infections and infestations
Large intestine infection
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Infections and infestations
Pneumonia
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Concussion
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Investigations
Blood urine present
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected naevus
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Nervous system disorders
Intracranial aneursym
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Schizophrenia
|
2.1%
11/523 • Number of events 11 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Anxiety
|
0.38%
2/523 • Number of events 2 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Acute psychosis
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Aggression
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Completed suicide
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Depression Suicidal
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Mania
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Psychiatric symptom
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Psychotic disorder
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Psychotic symptom
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Suicide attempt
|
0.19%
1/523 • Number of events 1 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
Other adverse events
| Measure |
ALKS 3831
n=523 participants at risk
Coated bilayer tablet
ALKS 3831: Olanzapine + samidorphan, daily oral dosing
|
|---|---|
|
Investigations
Weight increased
|
9.8%
51/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Nervous system disorders
Headache
|
7.1%
37/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Anxiety
|
6.1%
32/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Insomnia
|
5.9%
31/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Nausea
|
5.7%
30/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Investigations
Weight decreased
|
5.7%
30/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Investigations
Blood creatine phosphokinase increased
|
4.2%
22/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
17/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Psychiatric disorders
Schizophrenia
|
2.9%
15/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
15/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Investigations
Blood triglycerides increased
|
2.7%
14/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Constipation
|
2.5%
13/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Investigations
Low density lipoprotein increased
|
2.5%
13/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
13/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
12/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Investigations
Blood prolactin increased
|
2.3%
12/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Nervous system disorders
Dizziness
|
2.3%
12/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
11/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
11/523 • Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
- Publication restrictions are in place
Restriction type: OTHER