Clinical trial NCT01338818: Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
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 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: 2011-04-20
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder


Eligibility criteria: Inclusion Criteria:

1. Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)

Exclusion Criteria:

1. Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
2. Patients who during the core study developed cardiovascular disorders.
3. Pregnant women.
4. Patients who developed seizures during the core study.
5. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
6. Diagnosis or family history of Tourette's syndrome.
7. Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
timeFrame: Week 40 - Week 66
Secondary outcomes:
measure: 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.
timeFrame: week 40 - week 66
measure: Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score
timeFrame: week 40 - week 66
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: 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: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
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: 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: Århus C
country: Denmark
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: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Homburg
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: Luleå
country: Sweden
facility: Novartis Investigative Site
city: Malmö
country: Sweden
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.
citation: Ginsberg Y, Arngrim T, Philipsen A, Gandhi P, Chen CW, Kumar V, Huss M. Long-term (1 year) safety and efficacy of methylphenidate modified-release long-acting formulation (MPH-LA) in adults with attention-deficit hyperactivity disorder: a 26-week, flexible-dose, open-label extension to a 40-week, double-blind, randomised, placebo-controlled core study. CNS Drugs. 2014 Oct;28(10):951-62. doi: 10.1007/s40263-014-0180-4.