Phase 3
Completed N=201
Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
Source: ClinicalTrials.gov NCT01142596 ↗Enrolled (actual)
201
Serious AEs
18.4%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment — 12.9; 26.8; 64.5; 61.6 percentage of participants in category
Summary
This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in participants with schizophrenia. The first six weeks of the study will be double-blind and the remainder of the study will be open label. Participants in this study consist of participants who have completed the preceding short-term study (P06124 [NCT01098110]), who meet the inclusion criteria and wish to continue receiving study drug, and whom the investigators have deemed eligible for study participation. Participants who were on placebo twice daily (BID) in core trial P06124 will get placebo for the first 2 weeks then 5 mg asenapine BID for the next 4 weeks of double blind treatment, and will be re-randomized after week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 5 mg BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 10 mg BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. After re-randomization, drug will be administered open-label for 46 weeks. During this period dose is flexible can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment |
12.9; 26.8; 64.5; 61.6; 22.6; 11.6 | — |
| PRIMARY Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment |
22.6; 23.9; 64.5; 62.3; 12.9; 13.8 | — |
| PRIMARY Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52 |
-0.04; 0.91 | — |
| PRIMARY Change From Study P06125 Baseline in BMI at Week 52 |
0.35; 0.75 | — |
| PRIMARY Number of Participants With Extrapyramidal Symptoms |
11; 34; 1; 2; 2; 13 | — |
| PRIMARY Change From Study P06124 Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score at Endpoint |
-0.11; -0.46 | — |
| PRIMARY Change From Study P06125 Baseline in DIEPSS Total Score at Endpoint |
0.25; -0.03 | — |
| PRIMARY Change From Study P06124 Baseline in DIEPSS Item 9 Score at Endpoint |
0.14; -0.01 | — |
| PRIMARY Change From Study P06125 Baseline in DIEPSS Item 9 Score at Endpoint |
0.18; -0.02 | — |
| PRIMARY Change From Study P06124 Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 |
-0.09; -0.02 | — |
| PRIMARY Change From Study P06125 Baseline in HbA1c at Week 52 |
0.21; 0.12 | — |
| PRIMARY Change From Study P06124 Baseline in Fasting Glucose at Week 52 |
0.37; 0.28 | — |
| PRIMARY Change From Study P06125 Baseline in Fasting Glucose at Week 52 |
0.60; 0.00 | — |
| PRIMARY Change From Study P06124 Baseline in Insulin at Week 52 |
4.06; 2.24 | — |
| PRIMARY Change From Study P06125 Baseline in Insulin at Week 52 |
-5.61; 0.56 | — |
| PRIMARY Change From Study P06124 Baseline in Prolactin at Week 52 |
-37.46; -20.98 | — |
| PRIMARY Change From Study P06125 Baseline in Prolactin at Week 52 |
10.91; -1.59 | — |
| PRIMARY Number of Participants With Serious Adverse Events (AEs) |
5; 32 | — |
| PRIMARY Number of Participants With Non-serious AEs |
40; 131 | — |
| PRIMARY Percentage of Participants With Abnormalities on Electrocardiogram (ECG) at Study P06124 Baseline, Study P06125 Baseline and Week 52 |
41.9; 24.8; 34.1; 26.9; 42.9; 25.7 | — |
| PRIMARY Number of Participants Who Took Antiparkinsonian Drugs |
12; 40; 4; 8; 3; 16 | — |
| PRIMARY Median Time to Loss of Effect in Responders |
357.0; 177.0 | — |
| PRIMARY Median Time to Loss of Effect in Non-Responders |
53.0; 368.0 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has completed 42-day drug administration in the preceding short-term study (Protocol P06124), has exhibited efficacy (CGI-I at the completion of the preceding short-term study of markedly improved, moderately improved, or slightly improved), has no significant safety problems, and has been judged appropriate for study participation by the investigator.
- Male and female participants. Women who are of childbearing potential (i.e., not surgically sterile or post menopausal for at least 1 year) must use medically acceptable birth control. Medically acceptable birth control includes condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, insert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms during their participation in the study.
- Participant must have been explained the nature of the study by the investigator, and be able to provide written consent prior to the conduct of the tests/observation of the clinical study.
Exclusion Criteria
- A participant must not have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings that, in the investigator's opinion, preclude the participant's participation in the study
- A participant must not have a positive pregnancy test or be planning to become pregnant during the term of the study;
- A participant must not receive antipsychotics, antidepressants, mood stabilizers, anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are dopamine antagonist, or traditional herbal medication for psychiatric symptoms at the baseline;
- A participant must not be at risk of harming themselves or others, in the investigator's opinion;
- A participant must not have been determined to be unsuitable by an investigator.
Data sourced from ClinicalTrials.gov (NCT01142596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.