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Trial record 90 of 439 for:    Methylphenidate

Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD

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ClinicalTrials.gov Identifier: NCT00501293
Recruitment Status : Completed
First Posted : July 16, 2007
Results First Posted : January 15, 2010
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition ADHD
Intervention Drug: Methylphenidate Transdermal System
Enrollment 163
Recruitment Details Open-label, extension study of Methylphenidate Transdermal System (MTS) in subjects who had previously received study medication (MTS or placebo) in the antecedent study, SPD485-409 (NCT00499863). Upon entry into this study (SPD485-410), all subjects received MTS treatment regardless of the study treatment they had received in study SPD485-409.
Pre-assignment Details The study consisted of a dose optimization period (approx. 5 weeks) and a maintenance period (5 months). Methylphenidate Transdermal System (MTS)(10, 15, 20 or 30 mg / 9 hour dose patch) was applied once-daily on the alternating hip for a 9-hour wear time. One subject in the MTS group was enrolled in error and was removed prior to receiving drug.
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment. Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Period Title: Optimization Period
Started 110 53
Completed 109 53
Not Completed 1 0
Reason Not Completed
Enrolled in error             1             0
Period Title: Maintenance Period
Started 109 53
Completed 63 25
Not Completed 46 28
Reason Not Completed
Withdrawal by Subject             14             13
Lost to Follow-up             12             7
Adverse Event             6             6
Protocol Violation             2             1
Lack of Efficacy             4             1
Noncompliant with study medication             5             0
Went into rehabilitation             1             0
Would not wear patch             1             0
Application site reaction             1             0
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo Total
Hide Arm/Group Description Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment. Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment. Total of all reporting groups
Overall Number of Baseline Participants 110 53 163
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 53 participants 163 participants
<=18 years
110
 100.0%
53
 100.0%
163
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 53 participants 163 participants
14.5  (1.18) 14.5  (1.37) 14.5  (1.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 53 participants 163 participants
Female
27
  24.5%
14
  26.4%
41
  25.2%
Male
83
  75.5%
39
  73.6%
122
  74.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants 53 participants 163 participants
110 53 163
1.Primary Outcome
Title Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all subjects that received at least one dose of MTS.
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 109 53
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline measure 113.4  (9.59) 113.0  (11.20)
6 months 115.3  (9.91) 115.9  (14.82)
2.Primary Outcome
Title Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 109 53
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline measure 69.4  (7.42) 67.2  (7.69)
6 months 67.9  (7.79) 68.9  (8.28)
3.Primary Outcome
Title Pulse Rate
Hide Description [Not Specified]
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 109 53
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline measure 80.4  (11.34) 74.3  (9.73)
6 months 81.7  (11.60) 78.9  (12.27)
4.Primary Outcome
Title Electrocardiogram Results (QTcF Interval)
Hide Description QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 108 52
Mean (Standard Deviation)
Unit of Measure: msec
Baseline measure 391.8  (20.76) 393.2  (17.85)
6 months 395.3  (21.22) 393.5  (21.53)
5.Primary Outcome
Title Post Sleep Questionnaire (PSQ) Quality of Sleep
Hide Description Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 91 38
Measure Type: Number
Unit of Measure: Participants
Very poor 1 1
Poor 6 3
Average 34 10
Good 27 15
Very Good 23 9
6.Primary Outcome
Title Weight
Hide Description [Not Specified]
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 109 53
Mean (Standard Deviation)
Unit of Measure: lb
Baseline measure 127.05  (24.003) 131.95  (29.862)
6 months 134.55  (25.575) 124.78  (29.083)
7.Primary Outcome
Title Dermal Reactions
Hide Description Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Antecedent MTS and Antecedent Placebo
Hide Arm/Group Description:
Methylphenidate Transdermal System and Placebo Patch
Overall Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: Participants
0 (No evidence of irritation) 23
1 (Minimal erythema) 42
2 (Definite erythema) 82
3 (Erythema and papules) 6
4 (Definite edema) 0
5 (Erythema, edema, and papules) 4
6 (Vesicular eruption) 0
7 (Strong reaction beyond test site) 0
No dermal evaluation 5
8.Secondary Outcome
Title Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months
Hide Description The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) defined as subjects who were enrolled and received at least one dose of MTS and had at least one assessment of the primary efficacy endpoint.
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 106 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline measure 16.0  (12.00) 27.4  (12.91)
6 months 13.5  (10.55) 14.5  (9.53)
Change from baseline at 6 months -2.6  (11.80) -12.9  (15.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antecedent Methylphenidate Transdermal System (MTS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test of MTS at baseline and 6 months
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antecedent Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test of placebo at baseline and 6 months
9.Secondary Outcome
Title Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months
Hide Description The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 105 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline measure 26.5  (18.22) 42.3  (16.94)
6 months 22.5  (16.68) 24.6  (12.92)
Change from baseline at 6 months -3.9  (17.91) -17.7  (20.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antecedent Methylphenidate Transdermal System (MTS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test of MTS at baseline and 6 months
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antecedent Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test of placebo at baseline and 6 months
10.Secondary Outcome
Title Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Hide Description Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 106 52
Measure Type: Number
Unit of Measure: Participants
81 39
11.Secondary Outcome
Title Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.
Hide Description Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 106 52
Measure Type: Number
Unit of Measure: Participants
69 31
12.Secondary Outcome
Title Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months
Hide Description The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Not all subjects in the ITT population completed a YQOL-R.
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description:
Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
Overall Number of Participants Analyzed 84 33
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline measure 82.4  (14.28) 80.9  (14.61)
6 months 85.0  (13.00) 84.6  (10.78)
Change from baseline at 6 months 1.9  (9.57) 2.7  (6.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antecedent Methylphenidate Transdermal System (MTS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test of MTS at baseline and 6 months
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antecedent Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test of placebo at baseline and 6 months
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population defined as all subjects who received at least one dose of MTS.
 
Arm/Group Title Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Hide Arm/Group Description Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment. Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
All-Cause Mortality
Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/109 (2.75%)   1/53 (1.89%) 
Nervous system disorders     
Seizure  2/109 (1.83%)  0/53 (0.00%) 
Syncope  0/109 (0.00%)  1/53 (1.89%) 
Psychiatric disorders     
Hallucinations  1/109 (0.92%)  0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antecedent Methylphenidate Transdermal System (MTS) Antecedent Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   36/109 (33.03%)   32/53 (60.38%) 
Infections and infestations     
Nasopharyngitis  10/109 (9.17%)  3/53 (5.66%) 
Upper respiratory tract infection  11/109 (10.09%)  6/53 (11.32%) 
Metabolism and nutrition disorders     
Decreased appetite  12/109 (11.01%)  13/53 (24.53%) 
Nervous system disorders     
Headache  11/109 (10.09%)  8/53 (15.09%) 
Psychiatric disorders     
Irritability  6/109 (5.50%)  4/53 (7.55%) 
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Whitaker, MD
Organization: Shire Pharmaceutical
EMail: twhitaker@shire.com
Layout table for additonal information
Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00501293     History of Changes
Other Study ID Numbers: SPD485-410
First Submitted: July 12, 2007
First Posted: July 16, 2007
Results First Submitted: October 5, 2009
Results First Posted: January 15, 2010
Last Update Posted: April 26, 2017