Trial intelligence / Profile preview

Ritalin LA in Adult ADHD

NCT01259492Phase 3

Key facts

Status: Completed
Start: Nov 2010
Primary completion: Aug 2012
Countries: 9
Sponsor: Novartis
Modality: Small Molecules

Drugs: methylphenidate
Conditions: attention deficit hyperactivity disorder (ADHD)

Overview

Phase 3, randomised, double-blind trial of methylphenidate in attention deficit hyperactivity disorder (ADHD) (4 arms), sponsored by Novartis. Primary endpoints: DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale Total Score at 9 weeks, Sheehan Disability Scale Total Score at 9 weeks and 1 more. Started Nov 2010; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Ritalin LA 40 mg
Ritalin LA 40 mg/day
Ritalin LA 60 mg
Ritalin LA 60 mg/day
Ritalin LA 80 mg
Ritalin LA 80 mg/day
Placebo
Placebo

Who it enrols

Adult patients (18-60 years) with childhood-onset ADHD, BMI 18.5-35 kg/m2. Excludes patients with history of substance abuse, seizures, severe cardiovascular disorders, glaucoma, hyperthyroidism, Tourette's syndrome, or other significant psychiatric or medical conditions.

Endpoints

Primary

DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale Total Score9 weeks
Sheehan Disability Scale Total Score9 weeks
Percentage of Participants With Treatment Failures40 weeks

Secondary

Clinical Global Impression - Improvement Scale40 weeks
Conners' Adult ADHD Rating Scale Observer Short Version Total Score40 weeks
Adult Self-Report Scale Total Score40 weeks
Clinical Global Impression - Severity Scale40 weeks

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