Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01190267
First received: August 25, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia. This is an extension of base study P05896 (NCT01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study P05897. Participants in this extension study will receive open-label asenapine for 26 weeks. Throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.


Condition Intervention Phase
Schizophrenia, Paranoid
Schizophrenia, Disorganized
Schizophrenia, Undifferentiated
Drug: asenapine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was defined as a "treatment-emergent" AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period.

  • Number of Participants Who Discontinued Study Drug During Extension Study Due to an Adverse Event [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.


Enrollment: 204
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine
All enrolled participants receive open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which is increased to 5.0 mg BID on Day 4 (dose can be increased earlier at the investigator's discretion). Asenapine dosing is flexible for the remainder of the 26-week open-label drug administration period, and can be adjusted to either 2.5 mg or 5.0 mg BID at the investigator's discretion, based on tolerability and/or symptomatology.
Drug: asenapine
asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID
Other Name: Saphris®, SCH 900274, Org 5222

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 [NCT01190254]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met.
  • Must have completed the 8-week efficacy and safety trial (P05896 [NCT01190254]) and, according to the investigator's judgment, would benefit from long-term treatment.
  • Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 [NCT01190254]), in the opinion of the investigator.

Exclusion Criteria:

  • A female participant must not be pregnant and must not have the intention to become pregnant during the trial.
  • A participant must not be at imminent risk of self-harm or harm to others.
  • A participant must not currently be under involuntary inpatient commitment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190267

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01190267     History of Changes
Other Study ID Numbers: P05897, 2009-018038-12, MK-8274-021
Study First Received: August 25, 2010
Results First Received: July 14, 2014
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia, Disorganized
Schizophrenia, Paranoid
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Asenapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 30, 2014