A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00475735
First received: May 17, 2007
Last updated: August 28, 2013
Last verified: August 2013
Results First Received: October 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
Interventions: Drug: MK0249
Drug: Concerta (methylphenidate)
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
First Patient Dosed: 16 AUG 2007; Last Patient Last Treatment: 04 APR 2008. Six U.S. study centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Pre-Treatment consisted of 2 visits: Screening Visit1 & Baseline Randomization Visit2. Patients continuing after Visit1 entered a 1-wk placebo Run-in period. At Visit2, patients were assessed using the protocol eligibility criteria. Then, if deemed eligible, patients were randomized at Visit2 to one of six 2-period cross-over treatment sequences.

Reporting Groups
  Description
MK-0249 Then Placebo These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
Placebo Then MK-0249 These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
MK-0249 Then Concerta These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
Concerta Then MK-0249 These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
Concerta Then Placebo These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
Placebo Then Concerta These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    MK-0249 Then Placebo     Placebo Then MK-0249     MK-0249 Then Concerta     Concerta Then MK-0249     Concerta Then Placebo     Placebo Then Concerta  
STARTED     14     13     7     7     16     15  
COMPLETED     10     11     7     5     14     12  
NOT COMPLETED     4     2     0     2     2     3  
Adverse Event                 2                 0                 0                 0                 0                 0  
Lack of Efficacy                 1                 0                 0                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 1  
Protocol Violation                 0                 0                 0                 1                 0                 0  
Withdrawal by Subject                 1                 1                 0                 0                 0                 0  
DC due to AE but continuing                 0                 0                 0                 1                 2                 2  
DC due to no efficacy but Continuing                 0                 1                 0                 0                 0                 0  

Period 2:   Treatment Washout
    MK-0249 Then Placebo     Placebo Then MK-0249     MK-0249 Then Concerta     Concerta Then MK-0249     Concerta Then Placebo     Placebo Then Concerta  
STARTED     10     12 [1]   7     6 [1]   16 [2]   14 [2]
COMPLETED     10     10     7     6     16     14  
NOT COMPLETED     0     2     0     0     0     0  
Lost to Follow-up                 0                 1                 0                 0                 0                 0  
Protocol Violation                 0                 1                 0                 0                 0                 0  
[1] Includes 1 patient that discontinued Treatment Period 1 but continued the Study.
[2] Includes 2 patients that discontinued Treatment Period 1 but continued the Study.

Period 3:   Treatment Period 2
    MK-0249 Then Placebo     Placebo Then MK-0249     MK-0249 Then Concerta     Concerta Then MK-0249     Concerta Then Placebo     Placebo Then Concerta  
STARTED     10     10     7     6     16     14  
COMPLETED     10     9     7     4     15     13  
NOT COMPLETED     0     1     0     2     1     1  
Adverse Event                 0                 1                 0                 2                 0                 0  
Lack of Efficacy                 0                 0                 0                 0                 0                 1  
Withdrawal by Subject                 0                 0                 0                 0                 1                 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.
No text entered.

Reporting Groups
  Description
MK-0249 Then Placebo These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
Placebo Then MK-0249 These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
MK-0249 Then Concerta These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
Concerta Then MK-0249 These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
Concerta Then Placebo These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
Placebo Then Concerta These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
Total Total of all reporting groups

Baseline Measures
    MK-0249 Then Placebo     Placebo Then MK-0249     MK-0249 Then Concerta     Concerta Then MK-0249     Concerta Then Placebo     Placebo Then Concerta     Total  
Number of Participants  
[units: participants]
  14     13     7     7     16     15     72  
Age  
[units: years]
Mean ± Standard Deviation
  39.6  ± 9.2     36.9  ± 11.0     39.3  ± 7.5     39.0  ± 12.3     39.8  ± 11.1     36.5  ± 13.3     38.4  ± 10.8  
Gender  
[units: participants]
             
Female     6     4     2     5     3     7     27  
Male     8     9     5     2     13     8     45  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment   [ Time Frame: after 4 weeks of treatment ]

2.  Other Pre-specified:   Baseline AISRS   [ Time Frame: Baseline ]

3.  Secondary:   Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment   [ Time Frame: after 4 weeks of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   >/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;   [ Time Frame: after 4 weeks of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   >/=1-point Improvement in the CGI-S Score   [ Time Frame: 4 weeks of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score   [ Time Frame: 4 weeks of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.   [ Time Frame: 4 weeks of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score   [ Time Frame: 4 weeks of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00475735     History of Changes
Other Study ID Numbers: 0249-018, 2007_519
Study First Received: May 17, 2007
Results First Received: October 13, 2010
Last Updated: August 28, 2013
Health Authority: United States: Food and Drug Administration