Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder

NCT03768726 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: A1281201
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

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).

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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.

  A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)

Secondary Outcomes (18)

• 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 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 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)

Study Arms (1)

Ziprasidone

EXPERIMENTAL

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.

Drug: Ziprasidone; Drug: Placebo

Interventions

Ziprasidone DRUG

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.

Ziprasidone

Placebo DRUG

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.

Ziprasidone

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Evidence of personally signed and dated informed consent document by the legal representative and an assent document by the subject .
• Subjects and their legal guardians who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• The subjects must have received investigational product in Study A1281198 before entering this open label extension.
• In the investigator's opinion, the subject must be likely to benefit from antipsychotic therapy .
• All fertile male subjects and female subjects of childbearing potential who are sexually active and/or their legal guardians, as appropriate, must agree that a highly effective method of contraception

You may not qualify if:

• Any subjects from the preceding double blind trail who experienced a serious adverse event which required study medication to be discontinued and the subject to be withdrawn from the study. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation (confirmed and persistent Fridericia's correction (QTcF) \>480 msec or increase from baseline QTcF \>60 msec) during the preceding study.
• Subjects requiring any medications not allowed by the Concomitant Medication Table 12 (see "Concomitant Treatment(s)").
• Subjects who require treatment with drugs that are known to consistently prolong the QT interval (see Concomitant Medication Table 12).
• Subjects who are judged by the investigator as being at imminent risk of suicide.
• Subjects living in the same home as another study participant or having the same caregiver during the same enrollment period (Such subjects can be enrolled in the study at different times but may not be in the study at the same time).
• Subjects should be excluded or a risk assessment should be done to verify that it is safe for the subject to participate in the trial if the subject's responses on the C SSRS or other information based on the investigator's judgment indicate:
• Suicide ideation associated with actual intent and a method or plan such that a positive response ('Yes') is made on items 4 or 5 of the suicidal ideation subscale of the C SSRS; or
• Any suicide behaviors such that a determination of 'yes' is made to any of the suicide behavior items of the C SSRS.
• Pregnant female subjects, breastfeeding female subjects.
• Participation in other studies other than the preceding Study.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (9)

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Inova Clinical Trials and Research Centre

Fayetteville, Georgia, 30214, United States

Location

Attalla Consultants, LLC dba Institute for Behavioral Medicine

Smyrna, Georgia, 30082-2629, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

AIM Trials, LLC

Plano, Texas, 75093, United States

Location

Family Psychiatry of the Woodlands

The Woodlands, Texas, 77381, United States

Location

Eastside Therapeutic Resource Inc dba Core Clinical Research

Everett, Washington, 98201, United States

Location

Related Publications (2)

• Atkinson S, Bachinsky M, Raiter Y, Abreu P, Ianos C, Chappell P, Findling RL. 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). J Child Adolesc Psychopharmacol. 2022 Oct;32(8):453-458. doi: 10.1089/cap.2022.0030.

  PMID: 36282771 DERIVED

• Findling RL, Atkinson S, Bachinsky M, Raiter Y, Abreu P, Ianos C, Chappell P. Efficacy, Safety, and Tolerability of Flexibly Dosed Ziprasidone in Children and Adolescents with Mania in Bipolar I Disorder: A Randomized Placebo-Controlled Replication Study. J Child Adolesc Psychopharmacol. 2022 Apr;32(3):143-152. doi: 10.1089/cap.2021.0121. Epub 2022 Apr 7.

  PMID: 35394365 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

Prioritization of outcome measures per study team's discretion.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects who participate in A1281198 will be transitioned under double blind conditions (during the first two weeks of the study) to 26 weeks of treatment with flexibly dosed opened label ziprasidone.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects would completed A1281198 will be transitioned under double blind conditions to 26 weeks of treatment with flexibly dosed opened label ziprasidone.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: December 7, 2018
• Study Start: December 21, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: June 16, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (9)