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1082 – 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy And Safety Study Of Methylphenidate Hydrochloride Modified Release (mph-la) In Adults With Attention Deficit Hyperactivity Disorder (adhd)

  • M. Huss (a1), Y. Ginsberg (a2), A. Philipsen (a3), T. Tvedten (a4), T. Arngrim (a5), M. Greenbaum (a6), K. Carter (a7), C.-W. Chen (a7) and V. Kumar (a7)...

Abstract

Introduction

Recent epidemiology studies have reported the prevalence of adult ADHD to be approximately 4%, however approved treatments are limited.

Objectives

Primary objectives were to confirm the clinically-effective and safe dosage range of MPH-LA in adults with ADHD and evaluate the 6-month maintenance of effect.

Methods

Treatment Period (TP) 1: Patients were randomized to double-blind placebo, MPH-LA 40, 60, or 80 mg/day for 9- weeks (3-week titration, 6-week fixed-dose) to evaluate change in DSM-IV ADHD-RS and Sheehan Disability Scale (SDS) total score in TP1. TP2: 5-week titration to individual optimal dose. TP3: Patients were randomized to their optimal dose or placebo for 6-months double-blind withdrawal period to evaluate percentage of treatment failures during TP3.

Results

Improvement from baseline in total score on the DSM-IV ADHD-RS and SDS was significantly greater than placebo for all MPH-LA dose levels (table). Patients treated with MPH-LA had significantly lower treatment failure rates (21.34%) compared to placebo in TP3 (49.6%; odds-ratio (95%CI=0.3 (0.2, 0.4); p< 0.0001). The safety results were consistent with the established safety profile for MPH-LA.

[Improvement by week 9: DSM-IV ADHD-RS and SDS].

N=Full Analysis Set for TP1 (All randomized patients receiving one dose of study drug in TP1)MPH-LA (40mg) (N=174)MPH-LA (60mg) (N=175)MPH-LA (80mg) (N=179)Placebo (N=172)
Attention-Deficit/Hyperactivity Disorder Rating scale (DSM-IV ADHD-RS) (n)160155156161
LS Mean15.4514.7116.369.35
LS mean difference from placebo (95% CI)6.10 (3.68, 8.53)36 (2.92, 7.79)7.01 (4.59, 9.42) 
p valuep<0.0001p<0.0001p<0.0001 
Sheehan Disability Scale (n)151146148152
LS Mean5.894.906.473.03
LS mean difference from placebo (95% CI)2.86 (1.33, 4.39)1.87 (0.33, 3.41)3.44 (1.91, 4.97) 
p value0.00030.0176<0.0001 
Significance level (gatekeeping procedure)0.01670.02080.0313 

Conclusions

MPH-LA administered at 40-80mg/day demonstrated superior ADHD symptom control and reduction in functional impairment compared to placebo and demonstrated maintenance of effect over 6 months. No unexpected adverse events were observed.

Copyright

1082 – 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy And Safety Study Of Methylphenidate Hydrochloride Modified Release (mph-la) In Adults With Attention Deficit Hyperactivity Disorder (adhd)

  • M. Huss (a1), Y. Ginsberg (a2), A. Philipsen (a3), T. Tvedten (a4), T. Arngrim (a5), M. Greenbaum (a6), K. Carter (a7), C.-W. Chen (a7) and V. Kumar (a7)...

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1082 – 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy And Safety Study Of Methylphenidate Hydrochloride Modified Release (mph-la) In Adults With Attention Deficit Hyperactivity Disorder (adhd)

  • M. Huss (a1), Y. Ginsberg (a2), A. Philipsen (a3), T. Tvedten (a4), T. Arngrim (a5), M. Greenbaum (a6), K. Carter (a7), C.-W. Chen (a7) and V. Kumar (a7)...
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