Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
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|ClinicalTrials.gov Identifier: NCT01338818|
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : May 26, 2014
Last Update Posted : November 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder||Drug: Ritalin LA (methylphenidate hydrochloride extended release)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Ritalin LA
All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
Drug: Ritalin LA (methylphenidate hydrochloride extended release)
Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.
Other Name: Ritalin LA, methylphenidate hydrochloride extended release, RIT124D
- Number of Participants With Adverse Events, Serious Adverse Events and Deaths. [ Time Frame: Week 40 - Week 66 ]Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.
- Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score. [ Time Frame: week 40 - week 66 ]Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("rarely or never") to 3 ("Very often"). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing.
- Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score [ Time Frame: week 40 - week 66 ]SDS,5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338818
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|