Clinical trial NCT01259492: Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
Official title: A 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate HCl Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: Attention Deficit /Hyperactivity Disorder, hyperactivity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-14
Enrollment: 725
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

1. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
2. History of alcohol or substance abuse within the last six months.
3. History of seizures or use of anticonvulsant medication.
4. Any psychiatric condition that requires medication or may interfere with study participation.
5. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
6. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
7. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
8. Diagnosis or family history of Tourette's syndrome
9. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: 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)
measure: 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)
measure: 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
Secondary outcomes:
measure: Percentage of Patients With Improvement on Clinical Global Impression - Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1
timeFrame: Baseline 1 to End of Period 1 (Week 9)
measure: Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners' Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)
timeFrame: Baseline 1 to End of Period 2 (Week 14)
measure: Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)
timeFrame: Baseline 1 to End of Period 2 (Week 14)
measure: Number of Participants With Clinical Global Impression - Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)
timeFrame: Baseline 1 to End of Period 2 (Week 14)
measure: Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment
timeFrame: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)
measure: Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment
timeFrame: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)
measure: Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment
timeFrame: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)
measure: Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment
timeFrame: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)
measure: Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment
timeFrame: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)
measure: Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment
timeFrame: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Spring Valley
country: United States
facility: Novartis Investigative Site
state: California
city: Bradenton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Plam Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Libertyville
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Owensboro
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Troy
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Willingboro
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Bellevue
country: United States
facility: Novartis Investigative Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Heusden-Zolder
country: Belgium
facility: Novartis Investigative Site
city: Kessel-Lo
country: Belgium
facility: Novartis Investigative Site
city: Kortenberg
country: Belgium
facility: Novartis Investigative Site
city: Mechelen
country: Belgium
facility: Novartis Investigative Site
city: Uccle
country: Belgium
facility: Novartis Investigative Site
city: Antioquia
country: Colombia
facility: Novartis Investigative Site
city: Antioquia
country: Colombia
facility: Novartis Investigative Site
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Århus C
country: Denmark
facility: Novartis Investigative Site
city: Ahrensburg
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Ellwangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Homburg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Landau
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Limburg
country: Germany
facility: Novartis Investigative Site
city: Ludwigsburg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Naumburg
country: Germany
facility: Novartis Investigative Site
city: Nürnberg
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Westerstede/Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
city: Porsgrunn
country: Norway
facility: Novartis Investigative Site
city: Skien
country: Norway
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Benoni
country: South Africa
facility: Novartis Investigative Site
city: Melrose Arch
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Luleå
country: Sweden
facility: Novartis Investigative Site
city: Malmö
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Huss M, Ginsberg Y, Tvedten T, Arngrim T, Philipsen A, Carter K, Chen CW, Kumar V. Methylphenidate hydrochloride modified-release in adults with attention deficit hyperactivity disorder: a randomized double-blind placebo-controlled trial. Adv Ther. 2014 Jan;31(1):44-65. doi: 10.1007/s12325-013-0085-5. Epub 2013 Dec 27.