Long-Term Study of MP-214 in Patients With Schizophrenia
Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01626872
Collaborator
(none)
254
3
4
49
84.7
1.7
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
254 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Long-Term Extension Study of MP-214 in Patients With Schizophrenia
Study Start Date
:
Sep 1, 2012
Actual Primary Completion Date
:
Oct 1, 2016
Actual Study Completion Date
:
Oct 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MP-214 3mg
|
Drug: MP-214 3mg
In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
|
| Experimental: MP-214 6mg
|
Drug: MP-214 6mg
In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
|
| Experimental: MP-214 9mg
|
Drug: MP-214 9mg
In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
|
| Active Comparator: Risperidone 4mg
|
Drug: Risperidone 4mg
In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4. In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))]
The Numbers show Subjects with at least one Adverse Event
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Written informed consent obtained from the patient before the completion of Study A002-A4
-
Patients who have completed the A002-A4 study
Exclusion Criteria:
- Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (AEs), as judged by the investigator (or subinvestigator)
The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sapporo | Hokkaido | Japan | ||
| 2 | Seoul | Korea, Republic of | |||
| 3 | Taipei | Taiwan |
Sponsors and Collaborators
- Mitsubishi Tanabe Pharma Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01626872
Other Study ID Numbers:
- A002-A5
First Posted:
Jun 25, 2012
Last Update Posted:
Apr 12, 2021
Last Verified:
Apr 1, 2021
Keywords provided by Mitsubishi Tanabe Pharma Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Six patients who did not receive MP-214 during the open-label phase were excluded from the analysis population. |
| Arm/Group Title | MP-214 3mg | MP-214 6mg | MP-214 9mg |
|---|---|---|---|
| Arm/Group Description | |||
| Period Title: Overall Study | |||
| STARTED | 81 | 109 | 58 |
| COMPLETED | 29 | 43 | 34 |
| NOT COMPLETED | 52 | 66 | 24 |
Baseline Characteristics
| Arm/Group Title | MP-214 3mg | MP-214 6mg | MP-214 9mg | Total |
|---|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | |||
| Overall Participants | 81 | 109 | 58 | 248 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
38.0
(11.1)
|
40.8
(11.3)
|
42.5
(8.9)
|
40.3
(10.8)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
40
49.4%
|
56
51.4%
|
20
34.5%
|
116
46.8%
|
| Male |
41
50.6%
|
53
48.6%
|
38
65.5%
|
132
53.2%
|
Outcome Measures
| Title | Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
|---|---|
| Description | The Numbers show Subjects with at least one Adverse Event |
| Time Frame | Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks)) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MP-214 3mg | MP-214 6mg | MP-214 9mg |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 81 | 109 | 58 |
| Count of Participants [Participants] |
67
82.7%
|
92
84.4%
|
50
86.2%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | MP-214 3mg | MP-214 6mg | MP-214 9mg | |||
| Arm/Group Description | ||||||
All Cause Mortality |
||||||
| MP-214 3mg | MP-214 6mg | MP-214 9mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| MP-214 3mg | MP-214 6mg | MP-214 9mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/81 (17.3%) | 33/109 (30.3%) | 14/58 (24.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| Ankle fracture | 1/81 (1.2%) | 0/109 (0%) | 0/58 (0%) | |||
| Ligament sprain | 1/81 (1.2%) | 0/109 (0%) | 0/58 (0%) | |||
| Multiple fractures | 0/81 (0%) | 1/109 (0.9%) | 0/58 (0%) | |||
| Scar | 1/81 (1.2%) | 0/109 (0%) | 0/58 (0%) | |||
| Skin scar contracture | 1/81 (1.2%) | 0/109 (0%) | 0/58 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Breast cancer | 0/81 (0%) | 1/109 (0.9%) | 0/58 (0%) | |||
| Pregnancy, puerperium and perinatal conditions | ||||||
| Abortion spontaneous | 0/81 (0%) | 0/109 (0%) | 1/58 (1.7%) | |||
| Psychiatric disorders | ||||||
| Completed suicide | 0/81 (0%) | 0/109 (0%) | 1/58 (1.7%) | |||
| Insomnia | 0/81 (0%) | 1/109 (0.9%) | 2/58 (3.4%) | |||
| Mania | 1/81 (1.2%) | 0/109 (0%) | 0/58 (0%) | |||
| Psychiatric symptom | 0/81 (0%) | 1/109 (0.9%) | 0/58 (0%) | |||
| Schizophrenia | 9/81 (11.1%) | 26/109 (23.9%) | 11/58 (19%) | |||
| Schizophrenia, paranoid type | 1/81 (1.2%) | 1/109 (0.9%) | 1/58 (1.7%) | |||
| Somatoform disorder | 1/81 (1.2%) | 0/109 (0%) | 0/58 (0%) | |||
| Suicidal ideation | 0/81 (0%) | 1/109 (0.9%) | 0/58 (0%) | |||
| Suicide attempt | 0/81 (0%) | 2/109 (1.8%) | 0/58 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Cervical dysplasia | 0/81 (0%) | 1/109 (0.9%) | 0/58 (0%) | |||
| Surgical and medical procedures | ||||||
| Abortion induced | 0/81 (0%) | 1/109 (0.9%) | 0/58 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| MP-214 3mg | MP-214 6mg | MP-214 9mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 55/81 (67.9%) | 72/109 (66.1%) | 42/58 (72.4%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal discomfort | 1/81 (1.2%) | 3/109 (2.8%) | 3/58 (5.2%) | |||
| Constipation | 9/81 (11.1%) | 5/109 (4.6%) | 6/58 (10.3%) | |||
| Dental caries | 3/81 (3.7%) | 1/109 (0.9%) | 4/58 (6.9%) | |||
| Diarrhoea | 3/81 (3.7%) | 4/109 (3.7%) | 5/58 (8.6%) | |||
| Nausea | 4/81 (4.9%) | 2/109 (1.8%) | 4/58 (6.9%) | |||
| Vomiting | 5/81 (6.2%) | 3/109 (2.8%) | 4/58 (6.9%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 21/81 (25.9%) | 13/109 (11.9%) | 13/58 (22.4%) | |||
| Tinea pedis | 0/81 (0%) | 3/109 (2.8%) | 6/58 (10.3%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 3/81 (3.7%) | 5/109 (4.6%) | 3/58 (5.2%) | |||
| Excoriation | 1/81 (1.2%) | 1/109 (0.9%) | 3/58 (5.2%) | |||
| Investigations | ||||||
| Blood creatine phosphokinase increased | 1/81 (1.2%) | 7/109 (6.4%) | 0/58 (0%) | |||
| Weight increased | 4/81 (4.9%) | 11/109 (10.1%) | 2/58 (3.4%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 3/81 (3.7%) | 3/109 (2.8%) | 4/58 (6.9%) | |||
| Nervous system disorders | ||||||
| Akathisia | 15/81 (18.5%) | 15/109 (13.8%) | 2/58 (3.4%) | |||
| Dizziness | 4/81 (4.9%) | 6/109 (5.5%) | 2/58 (3.4%) | |||
| Extrapyramidal disorder | 8/81 (9.9%) | 7/109 (6.4%) | 4/58 (6.9%) | |||
| Headache | 9/81 (11.1%) | 7/109 (6.4%) | 4/58 (6.9%) | |||
| Somnolence | 2/81 (2.5%) | 6/109 (5.5%) | 1/58 (1.7%) | |||
| Tremor | 0/81 (0%) | 5/109 (4.6%) | 4/58 (6.9%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 3/81 (3.7%) | 7/109 (6.4%) | 2/58 (3.4%) | |||
| Insomnia | 4/81 (4.9%) | 12/109 (11%) | 8/58 (13.8%) | |||
| Restlessness | 1/81 (1.2%) | 4/109 (3.7%) | 3/58 (5.2%) | |||
| Schizophrenia | 12/81 (14.8%) | 12/109 (11%) | 11/58 (19%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Oropharyngeal pain | 1/81 (1.2%) | 0/109 (0%) | 3/58 (5.2%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Eczema | 1/81 (1.2%) | 5/109 (4.6%) | 6/58 (10.3%) | |||
| Haemorrhage subcutaneous | 0/81 (0%) | 0/109 (0%) | 3/58 (5.2%) | |||
| Vascular disorders | ||||||
| Hypertension | 3/81 (3.7%) | 4/109 (3.7%) | 3/58 (5.2%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Clinical Trials, Information Desk |
|---|---|
| Organization | Mitsubishi Tanabe Pharma Corporation |
| Phone | |
| cti-inq-ml@ml.mt-pharma.co.jp |
Responsible Party:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01626872
Other Study ID Numbers:
- A002-A5
First Posted:
Jun 25, 2012
Last Update Posted:
Apr 12, 2021
Last Verified:
Apr 1, 2021