Clinical trial

A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Subjects With Acute Manic or Mixed Episodes Associated With Bipolar I Disorder

Name

P05898

Description

This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed study P06107.

Trial arms

Trial start

2011-06-16

Estimated PCD

2014-09-05

Trial end

2014-09-05

Status

Completed

Phase

Early phase I

Treatment

Asenapine

One flavored asenapine sublingual tablet (containing either 2.5, 5 or 10 mg asenapine) twice daily (BID), starting at 2.5 mg on Day 1 for three consecutive days. Normally on Day 4, the dose will increase to 5 mg BID beginning with the evening dose. Normally on Day 7, the dose will increase to 10 mg BID beginning with the evening dose. The dose may be up-titrated earlier than Days 4 and 7 at the investigator's discretion. Beginning on Day 8 (or after at least 1 day on 10 mg BID), asenapine dosing will be flexible (2.5, 5, or 10 mg BID) until up to Week 50.

Arms:

Asenapine/Asenapine, Placebo/Asenapine

Other names:

SCH 900274, ORG 5222

Rescue medication

For participants whose symptoms worsen or are not adequately controlled on assigned treatment, rescue medication may be administered during the trial in the following circumstances. For the control of agitation, anxiety, insomnia, restlessness, or akathisia and extrapyramidal symptoms (EPS) some benzodiazepines (i.e., lorazepam \[up to 4 mg/day\] or an equivalent dose of short-acting benzodiazepines) and EPS medications (i.e., anticholinergics) are allowed. Benadryl (diphenhydramine) and beta blockers are also permitted, provided that they are not taken within 8 hours of efficacy assessments.

Arms:

Asenapine/Asenapine, Placebo/Asenapine

Size

322

Primary endpoint

Number of Participants Who Experienced Clinical or Laboratory Adverse Events

Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)

Eligibility criteria

Inclusion Criteria: * Completed study P06107 and demonstrated acceptable degree of compliance with medication, visits and other study requirements * Must be male or a female who is not of childbearing potential and is not sexually active or is using a medically accepted method of contraception; or female who is not pregnant, or not lactating. * Must have a caregiver or responsible person living with the participant who agrees to provide support to ensure compliance with treatment, visits, and protocol procedures Exclusion Criteria: * Positive pregnancy test or intention to become pregnant during the study * At imminent risk of self-harm or harm to others * Under involuntary inpatient commitment * Known serological evidence of human immunodeficiency virus (HIV) antibody

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 322, 'type': 'ACTUAL'}}

Updated at

2024-05-22

1 organization

Organization

Organon and Co