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Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01227668
First received: October 22, 2010
Last updated: March 31, 2014
Last verified: March 2014
Results First Received: November 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Irritability Associated With Autistic Disorder
Interventions: Drug: Aripiprazole
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 215 participants enrolled, 58 discontinued during screening and before entry into Phase 1. Of the 58 who discontinued, 1 withdrew for an adverse event, 12 withdrew consent, 8 were lost to follow-up, 36 no longer met study criteria, and 1 withdrew for other reason.

Reporting Groups
  Description
Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)

Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.

Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.

Placebo Phase 2 only: Participants received placebo for 16 weeks.

Participant Flow for 2 periods

Period 1:   Phase 1 (Stabilization Phase)
    Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)     Placebo  
STARTED     157 [1]   0  
Received Treatment     155     0  
COMPLETED     85     0  
NOT COMPLETED     72     0  
Adverse Event                 12                 0  
Withdrawal by Subject                 7                 0  
Lost to Follow-up                 8                 0  
Sponsor's administrative reason                 11                 0  
No longer meets study criteria                 7                 0  
Lack of Efficacy                 25                 0  
Poor compliance/noncompliance                 2                 0  
[1] Randomized

Period 2:   Phase 2 (Randomization Phase)
    Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)     Placebo  
STARTED     41 [1]   44 [1]
Received Treatment     39     43  
COMPLETED     22     19  
NOT COMPLETED     19     25  
Adverse Event                 0                 1  
Withdrawal by Subject                 5                 0  
Lost to Follow-up                 1                 0  
Lack of Efficacy                 13                 23  
Poor compliance/noncompliance                 0                 1  
[1] Randomized



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who were randomized to receive treatment in Phase 2

Reporting Groups
  Description
Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose) Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
Placebo Phase 2: Participants received placebo for 16 weeks.
Total Total of all reporting groups

Baseline Measures
    Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)     Placebo     Total  
Number of Participants  
[units: participants]
  41     44     85  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  10.1  ± 2.80     10.8  ± 2.77     10.4  ± 2.79  
Age, Customized  
[units: Years]
Median ( Full Range )
  10.0  
  ( 6 to 16 )  
  11.0  
  ( 6 to 17 )  
  10.0  
  ( 6 to 17 )  
Gender  
[units: participants]
     
Female     11     6     17  
Male     30     38     68  
Race/Ethnicity, Customized  
[units: Participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     3     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     8     11     19  
White     31     28     59  
Other     2     1     3  



  Outcome Measures
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1.  Primary:   Percentage of Patients Relapsing by Week 16   [ Time Frame: From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment ]

2.  Secondary:   Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline (end of Phase 1) to Week 16 of Phase 2 ]

3.  Secondary:   Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline (end of Phase 1) to Week 16 of Phase 2 ]

4.  Secondary:   Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1   [ Time Frame: Weekly from Week 1 to Week 26 and continuously to end of treatment ]

5.  Other Pre-specified:   Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs During Phase 2   [ Time Frame: Weekly from Weeks 1 through 16 (end of treatment) of Phase 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01227668     History of Changes
Other Study ID Numbers: CN138-603
Study First Received: October 22, 2010
Results First Received: November 7, 2013
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration