26-WEEK OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (MOST RECENT EPISODE MANIC)
Overview
- Phase
- Phase 3
- Intervention
- Ziprasidone
- Conditions
- Bipolar Disorder
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 23
- Locations
- 9
- Primary Endpoint
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents with Bipolar I Disorder (current or most recent episode manic).
Detailed Description
Study A1281201 is a 6 month, open label extension study of the ongoing double blind, randomized, placebo controlled study of ziprasidone in pediatric Bipolar Disorder (Study A1281198). Study A1281201 will enroll adolescents aged 10 to 17 years with Bipolar I Disorder who have participated in double blind Study A1281198. In order to be enrolled in this open label extension trial, subjects must have met the enrollment criteria for Study A1281198, and must meet the inclusion and exclusion criteria for Study A1281201 at the extension study Baseline visit (last visit in the double blind study). The purpose of adding this extension study to the ongoing Geodon pediatric bipolar program is to obtain additional longer term safety data in children and adolescents with Bipolar I disorder treated with ziprasidone.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ziprasidone
All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period. During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules. During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.
Intervention: Ziprasidone
Ziprasidone
All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period. During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules. During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)
An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.
Secondary Outcomes
- Number of Participants With Laboratory Abnormalities(A1281201: Day 1 up to 1 Week after last dose of study medication (maximum up to 27 Weeks))
- Number of Participants With Physical Examination Abnormalities at Baseline and Week 26(Baseline (last measurement from A1281198), Week 26 of A1281201)
- Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit(Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26(Baseline (last measurement from A1281198), A1281201: Week 26)
- Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit(Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26(Baseline (last measurement from A1281198), A1281201: Week 1, 2, 6, 14, 22, 26)
- Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26(Baseline (last measurement from A1281198), A1281201: Week 26)
- Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Movement Cluster Subscale Score of Abnormal Involuntary Movement Scale (AIMS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit(Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27))
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26(Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26)