Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

NCT01338818 | Completed Phase 3 Results

• 2 other identifiers: CRIT124D2302E12011-000210-19
• Study Type: interventional
• Target: 299
• Locations: 6 countries
• Sites: 48

Brief Summary

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

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Attention Deficit /Hyperactivity Disorder,; hyperactivity

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events, Serious Adverse Events and Deaths.

  Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.

  Week 40 - Week 66

Secondary Outcomes (2)

• 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.

  week 40 - week 66

• Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score

  week 40 - week 66

Study Arms (1)

Ritalin LA

EXPERIMENTAL

All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).

Drug: Ritalin LA (methylphenidate hydrochloride extended release)

Interventions

Ritalin LA (methylphenidate hydrochloride extended release) DRUG

Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.

Also known as: Ritalin LA, methylphenidate hydrochloride extended release, RIT124D

Ritalin LA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)

You may not qualify if:

• 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.
• Patients who during the core study developed cardiovascular disorders.
• Pregnant women.
• Patients who developed seizures during the core study.
• Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
• Diagnosis or family history of Tourette's syndrome.
• Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (48)

Novartis Investigative Site

Little Rock, Arkansas, 72205, United States

Location

Novartis Investigative Site

Beverly Hills, California, 90210, United States

Location

Novartis Investigative Site

Spring Valley, California, 91978-1522, United States

Location

Novartis Investigative Site

Bradenton, Florida, 34208, United States

Location

Novartis Investigative Site

Orlando, Florida, 32806, United States

Location

Novartis Investigative Site

West Plam Beach, Florida, 33407, United States

Location

Novartis Investigative Site

Libertyville, Illinois, 60048, United States

Location

Novartis Investigative Site

Owensboro, Kentucky, 42301, United States

Location

Novartis Investigative Site

Las Vegas, Nevada, 89119, United States

Location

Novartis Investigative Site

Las Vegas, Nevada, 89128, United States

Location

Novartis Investigative Site

Fargo, North Dakota, 58103, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43210, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19149, United States

Location

Novartis Investigative Site

Houston, Texas, 77007, United States

Location

Novartis Investigative Site

Bellevue, Washington, 98004, United States

Location

Novartis Investigative Site

Seattle, Washington, 98104, United States

Location

Novartis Investigative Site

Bruges, Belgium, 8310, Belgium

Location

Novartis Investigative Site

Heusden-Zolder, Belgium, 3550, Belgium

Location

Novartis Investigative Site

Uccle, Belgium, 1180, Belgium

Location

Novartis Investigative Site

Kessel-Lo, 3010, Belgium

Location

Novartis Investigative Site

Mechelen, 2800, Belgium

Location

Novartis Investigative Site

Santa Fe de Antioquia, Antioquia, 0000, Colombia

Location

Novartis Investigative Site

Antioquia, Colombia

Location

Novartis Investigative Site

Århus C, 8000, Denmark

Location

Novartis Investigative Site

Bamberg, Germany, 96047, Germany

Location

Novartis Investigative Site

Berlin, Germany, 12203, Germany

Location

Novartis Investigative Site

Hamburg, Germany, 20259, Germany

Location

Novartis Investigative Site

Ludwigsburg, Germany, 71636, Germany

Location

Novartis Investigative Site

Mainz, Germany, 55131, Germany

Location

Novartis Investigative Site

München, Germany, 80333, Germany

Location

Novartis Investigative Site

Naumburg, Germany, 06618, Germany

Location

Novartis Investigative Site

Nuremberg, Germany, 90419, Germany

Location

Novartis Investigative Site

Wolfsburg, Germany, 38444, Germany

Location

Novartis Investigative Site

Berlin, 10629, Germany

Location

Novartis Investigative Site

Dresden, 01129, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79104, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Homburg, 66421, Germany

Location

Novartis Investigative Site

Landau, 76829, Germany

Location

Novartis Investigative Site

Leipzig, 04157, Germany

Location

Novartis Investigative Site

Limburg, 65549, Germany

Location

Novartis Investigative Site

Mannheim, 68159, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Westerstede/Oldenburg, 26655, Germany

Location

Novartis Investigative Site

Würzburg, 97070, Germany

Location

Novartis Investigative Site

Luleå, 972 35, Sweden

Location

Novartis Investigative Site

Malmo, 211 53, Sweden

Location

Related Publications (2)

• 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.

  PMID: 35201607 DERIVED

• 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.

  PMID: 25183661 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

8627788300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 20, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 24, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-11

Locations

DK (1); CO (2); SE (2); DE (22); US (16); BE (5)