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Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD

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ClinicalTrials.gov Identifier: NCT00780208
Recruitment Status : Completed
First Posted : October 27, 2008
Results First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adult Attention Deficit Hyperactivity Disorder (ADHD)
Intervention Drug: Daytrana (methylphenidate patch)
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daytrana (Methylphenidate Patch)
Hide Arm/Group Description

Methylphenidate patch

Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.

Period Title: Overall Study
Started 14
Completed 8
Not Completed 6
Arm/Group Title Daytrana (Methylphenidate Patch)
Hide Arm/Group Description

Methylphenidate patch

Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
28.5
(22 to 44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
8
  57.1%
Male
6
  42.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
 100.0%
1.Primary Outcome
Title ADHD Symptom Severity
Hide Description Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daytrana (Methylphenidate Patch)
Hide Arm/Group Description:

Methylphenidate patch

Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-17.93  (5.89)
2.Secondary Outcome
Title Number of Participants With Positive Drug Screen
Hide Description Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daytrana (Methylphenidate Patch)
Hide Arm/Group Description:

Methylphenidate patch

Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.

Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
4
  28.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daytrana (Methylphenidate Patch)
Hide Arm/Group Description

Methylphenidate patch

Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.

All-Cause Mortality
Daytrana (Methylphenidate Patch)
Affected / at Risk (%)
Total   0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Daytrana (Methylphenidate Patch)
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Daytrana (Methylphenidate Patch)
Affected / at Risk (%) # Events
Total   10/14 (71.43%)    
General disorders   
Headache *  4/14 (28.57%)  5
Dry mouth *  2/14 (14.29%)  2
Paresthesia *  1/14 (7.14%)  2
Insomnia *  1/14 (7.14%)  1
Dehydration *  1/14 (7.14%)  1
Tooth pain *  1/14 (7.14%)  1
Hot flash *  1/14 (7.14%)  1
Infections and infestations   
Yeast infection *  1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders   
Muscle cramps *  1/14 (7.14%)  1
Psychiatric disorders   
Hyperactivity *  1/14 (7.14%)  1
Depression *  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
Sinus/cold/allergies *  1/14 (7.14%)  1
Skin and subcutaneous tissue disorders   
Skin reaction *  8/14 (57.14%)  9
Canker sores *  1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
Small sample size and open-label design, preliminary nature of the trial precludes the ability to make treatment recommendations based on the results.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aimee McRae-Clark, Professor
Organization: Medical University of South Carolina
Phone: 843-792-5216
EMail: mcraeal@musc.edu
Layout table for additonal information
Responsible Party: Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00780208     History of Changes
Other Study ID Numbers: HR#16784
First Submitted: October 23, 2008
First Posted: October 27, 2008
Results First Submitted: May 8, 2018
Results First Posted: June 14, 2018
Last Update Posted: June 14, 2018