CompletedPhase 3

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

United States725 participantsStarted 2010-11

Plain-language summary

This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood
✓. Female patients of childbearing potential must be practicing an acceptable method of contraception.

Exclusion criteria

✕. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
✕. History of alcohol or substance abuse within the last six months.
✕. History of seizures or use of anticonvulsant medication.
✕. Any psychiatric condition that requires medication or may interfere with study participation.
✕. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
✕. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
✕. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
✕. Diagnosis or family history of Tourette's syndrome

What they're measuring

Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment

Timeframe: Baseline 1 to End of Period 1 (Week 9)

Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment

Timeframe: Baseline 1 to End of Period 1 (Week 9)

Percentage of Participants With Treatment Failures During Period 3

Timeframe: Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40

Trial details

NCT IDNCT01259492

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

Results submitted2013-08-06

View on ClinicalTrials.gov More Attention Deficit/Hyperactivity Disorder trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood
✓. Female patients of childbearing potential must be practicing an acceptable method of contraception.

Exclusion criteria

✕. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
✕. History of alcohol or substance abuse within the last six months.
✕. History of seizures or use of anticonvulsant medication.
✕. Any psychiatric condition that requires medication or may interfere with study participation.
✕. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
✕. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
✕. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
✕. Diagnosis or family history of Tourette's syndrome

What they're measuring

Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment

Timeframe: Baseline 1 to End of Period 1 (Week 9)

Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment

Timeframe: Baseline 1 to End of Period 1 (Week 9)

Percentage of Participants With Treatment Failures During Period 3

Timeframe: Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40