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Trial record 80 of 439 for:    Methylphenidate

Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD

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ClinicalTrials.gov Identifier: NCT00506285
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
frederick reimherr, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: Methylphenidate Transdermal System (MTS)
Other: placebo patch
Enrollment 92
Recruitment Details Subjects (n=92) were recruited from 4-16-2007 through 10-24-2008. They were seen at the Psychiatry Research Clinic at the University of Utah School of Medicine.
Pre-assignment Details There were 3 screening visits. Subjects met DSM-IV &/or Utah criteria for adult ADHD, experiencing at least moderate impairment. Most DSM-IV axis-I disorders were excluded. Of 92 subjects enrolled, 65 were randomized and produced double-blind data. The assessment procedure was more extensive than normal, leading to a high dropout rate.
Arm/Group Title A) MTS Arm Was 1st and PBO Arm Was 2nd B) PBO Arm Was 1st and MTS Arm Was 2nd
Hide Arm/Group Description MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm. Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
Period Title: 3 Week Screening Phase
Started 46 46
Completed 29 36
Not Completed 17 10
Reason Not Completed
Withdrawal by Subject             17             10
Period Title: Double Blind Cross-Over Phase
Started 29 36
Received at Least 1 Dose MTS 29 31
Completed 20 31
Not Completed 9 5
Reason Not Completed
Withdrawal by Subject             4             3
Lost to Follow-up             5             2
Period Title: 6-month Open Label Phase
Started 20 31
Completed 10 19
Not Completed 10 12
Reason Not Completed
Lost to Follow-up             1             7
Withdrawal by Subject             9             5
Arm/Group Title a) Methylphenidate Transdermal System Was Taken First B Placebo Patch Was Used First Total
Hide Arm/Group Description Subjects took Methylphenidate Transdermal System in the first treatment arm and placebo patch in the second treatment arm Placebo patch was used in the first treatment arm and MTS in the second treatment arm. Total of all reporting groups
Overall Number of Baseline Participants 29 36 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 36 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
36
 100.0%
65
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 36 participants 65 participants
30.4  (9.5) 40.4  (11.8) 35.2  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 36 participants 65 participants
Female
8
  27.6%
13
  36.1%
21
  32.3%
Male
21
  72.4%
23
  63.9%
44
  67.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 36 participants 65 participants
29 36 65
Wender-Reimherr Adult Attention Deficit Disorder Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants 36 participants 65 participants
21.5  (4.2) 21.3  (4.1) 21.4  (4.2)
[1]
Measure Description: This is a investigator rated scale of ADHD symptoms. It assessed the 7 domains of the Utah Criteria using scores of 0 (none) to 4 (highly symptomatic). Total possible scores range from 0 (no symptoms) to 28 (worst possible score).
1.Primary Outcome
Title Wender Reimherr Adult Attention Deficit Disorder Scale
Hide Description This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.
Time Frame Double-blind endpoints during MTS and placebo arms
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects given active treatment "last observation carried forward" using a mixed models design.
Arm/Group Title Scores in MTS Arm Scores in Placebo Arm
Hide Arm/Group Description:
Average WRAADDS scores at end of active treatment (MTS) arm
Average WRAADDS scores at end of placebo arm
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.0  (7.4) 17.9  (6.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Scores in MTS Arm, Scores in Placebo Arm
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments F(1,47)=26.7, p=.001
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Mixed Models Analysis
Comments F(1,47)=26.7, p=.001
2.Secondary Outcome
Title Conners' Adult ADHD Rating Scales (CAARS)
Hide Description Measures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms.
Time Frame Double-blind endpoints for MTS and placebo arms
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Scores in MTS Arm Scores in Placebo Arm
Hide Arm/Group Description:
Average CAARS score at end of active treatment
Average CAARS score at end of placebo treatment
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.8  (19.1) 49.5  (18.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Scores in MTS Arm, Scores in Placebo Arm
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments mixed models analysis
Statistical Test of Hypothesis P-Value .001
Comments F(1,47)=24.8, p=.001
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
Adverse Event Reporting Description A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
 
Arm/Group Title MTS Arm Placebo Arm
Hide Arm/Group Description Adverse events and Serious AEs during active treatment (MTS) arm Adverse events and Serious AEs during placebo arm
All-Cause Mortality
MTS Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MTS Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/61 (0.00%)      0/58 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MTS Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/61 (39.34%)      10/58 (17.24%)    
Gastrointestinal disorders     
decreased appetite   7/61 (11.48%)  7 2/58 (3.45%)  2
General disorders     
insomnia/sleep   19/61 (31.15%)  19 4/58 (6.90%)  4
dry eyes, nose, mouth   8/61 (13.11%)  8 1/58 (1.72%)  1
headache   8/61 (13.11%)  8 4/58 (6.90%)  4
anxiety   7/61 (11.48%)  7 1/58 (1.72%)  1
Psychiatric disorders     
anger/irritability   7/61 (11.48%)  7 3/58 (5.17%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barrie K. Marchant
Organization: Psychiatry Research Clinic
Phone: 801 585-6663
EMail: barriemarchant@aol.com
Layout table for additonal information
Responsible Party: frederick reimherr, University of Utah
ClinicalTrials.gov Identifier: NCT00506285     History of Changes
Other Study ID Numbers: 20405
SPD485.420-Reimherr ( Other Grant/Funding Number: Shire Pharma )
First Submitted: July 23, 2007
First Posted: July 25, 2007
Results First Submitted: October 19, 2012
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015