Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506285
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2007-07-23
Brief Title:
Methylphenidate Transdermal System MTS in the Treatment of Adult ADHD
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Methylphenidate Transdermal System MTS in the Treatment of Adult ADHD
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will look at the effectiveness of Methylphenidate Transdermal System MTS in treating adult ADHD MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD Subjects will experience two screening visits and one baseline visit Those who meet admission criteria will enter the double-blind phase This will involve two 4-week treatment periods one of which will involve the use of MTS and the other a placebo patch Subjects who complete the double-blind phase will be allowed to enter a 180-day open-label MTS phase designed to assess long-term effects
Detailed Description:
ADHD affects from 3 to 5 of children persists into adolescence in 40 to 70 of these children and continues into adulthood in at least 50 of affected adolescents Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used While the extended release formulations represent an improvement over the immediate release versions significant problems remain for many patients In particular most have been designed with the goal of providing medication only during school hours and a short time period after school In adults there is a frequent need for much more extended duration of treatment MTS is a new form of methylphenidate that provides medication in a transdermal patch delivery system It has a very even slowly ascending pharmacokinetic profile MTSs very stable slowly increasing blood level should overcome the problems noted above with a delivery system that is more convenient for many patients It is currently approved for treatment of childhood ADHD with effectiveness and safety profiles similar to other forms of methylphenidate This study will be the first to evaluate the effectiveness and safety of MTS in adult ADHD
This is a double-blind placebo-controlled randomized crossover trial comparing MTS with placebo patch The double-blind trial will be preceded by an enrollment period consisting of two screening visits followed as quickly as possible by a baseline visit Patients who continue to meet admission criteria at baseline will be randomized into the first of two 4-week treatment periods We will attempt to reach the highest tolerated dose size of MTS within 2 weeks and then observe the response over the last two weeks of each crossover phase The double-blind period will be followed by a 180 day open-treatment flexible-dose phase designed to assess long-term effects
This is a double-blind placebo-controlled randomized crossover trial comparing MTS with placebo patch The double-blind trial will be preceded by an enrollment period consisting of two screening visits followed as quickly as possible by a baseline visit Patients who continue to meet admission criteria at baseline will be randomized into the first of two 4-week treatment periods We will attempt to reach the highest tolerated dose size of MTS within 2 weeks and then observe the response over the last two weeks of each crossover phase The double-blind period will be followed by a 180 day open-treatment flexible-dose phase designed to assess long-term effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SPD485420-Reimherr | OTHER_GRANT | Shire Pharma | None |