Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00904670
First received: May 18, 2009
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Quillivant Oral Suspension XR
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
The study consisted of an open-label (OL) dose-optimization phase (4 to 6 weeks), and a placebo-controlled, double blind (DB) 2-way crossover phase (1 week each) with no dose adjustments.

Reporting Groups
  Description
OL Phase (NWP06); DB Phase (Placebo First, Then NWP06) Placebo-matched to NWP06 oral suspension once daily for 1 week in the first intervention period followed by NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the second intervention period.
OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo) NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the first intervention period followed by placebo-matched to NWP06 oral suspension once daily for 1 week in the second intervention period.

Participant Flow for 3 periods

Period 1:   Open Label Phase
    OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)     OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)  
STARTED     23     22  
COMPLETED     17     22  
NOT COMPLETED     6     0  
Withdrawal by Subject                 2                 0  
Adverse Event                 2                 0  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 1                 0  

Period 2:   First Intervention Period
    OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)     OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)  
STARTED     17     22  
COMPLETED     17     22  
NOT COMPLETED     0     0  

Period 3:   Second Intervention Period
    OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)     OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)  
STARTED     17     22  
COMPLETED     17     22  
NOT COMPLETED     0     0  



  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.
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.

Reporting Groups
  Description
Entire Study Population Includes all randomized participants who received at least 1 dose of study medication.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  45  
Age  
[units: years]
Mean ± Standard Deviation
  8.8  ± 1.69  
Gender  
[units: participants]
 
Female     12  
Male     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose   [ Time Frame: Hour 4 post-dose ]

2.  Secondary:   Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale   [ Time Frame: 0.75, 2, 8, 10, 12 hours post-dose ]

3.  Secondary:   SKAMP Attention Subscale Score Over 12 Hours   [ Time Frame: 0.75, 2, 4, 8, 10, 12 hours post-dose ]

4.  Secondary:   SKAMP Deportment Subscale Score Over 12 Hours   [ Time Frame: 0.75, 2, 4, 8, 10, 12 hours post-dose ]

5.  Secondary:   Permanent Product Measure of Performance (PERMP) Score Over 12 Hours   [ Time Frame: 0.75, 2, 4, 8, 10, 12 hours post-dose ]

6.  Secondary:   SKAMP Combined Scores Over 12 Hours   [ Time Frame: 0.75, 2, 8, 10, 12 hours post-dose ]

7.  Other Pre-specified:   SKAMP Quality of Work Subscale Score Over 12 Hours   [ Time Frame: 0.75, 2, 4, 8, 10, 12 hours post-dose ]

8.  Other Pre-specified:   SKAMP Compliance Subscale Score Over 12 Hours   [ Time Frame: 0.75, 2, 4, 8, 10, 12 hours post-dose ]


  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
Results for primary outcome is presented as absolute values and not as change from pre-dose and the secondary outcomes are presented at each post-dose time-point and not pre-dose, as planned.


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00904670     History of Changes
Other Study ID Numbers: NWP06-ADD-100, B7491007
Study First Received: May 18, 2009
Results First Received: May 27, 2014
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration