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

NCT ID: NCT01338818

Last Updated: 2014-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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Conditions

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Attention Deficit/Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ritalin LA

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).

Group Type EXPERIMENTAL

Ritalin LA (methylphenidate hydrochloride extended release)

Intervention Type 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.

Interventions

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Ritalin LA (methylphenidate hydrochloride extended release)

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.

Intervention Type DRUG

Other Intervention Names

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Ritalin LA, methylphenidate hydrochloride extended release, RIT124D

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Little Rock, Arkansas, United States

Site Status

Novartis Investigative Site

Beverly Hills, California, United States

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Novartis Investigative Site

Spring Valley, California, United States

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Novartis Investigative Site

Bradenton, Florida, United States

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Novartis Investigative Site

Orlando, Florida, United States

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Novartis Investigative Site

West Plam Beach, Florida, United States

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Novartis Investigative Site

Libertyville, Illinois, United States

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Novartis Investigative Site

Owensboro, Kentucky, United States

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Novartis Investigative Site

Las Vegas, Nevada, United States

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Novartis Investigative Site

Las Vegas, Nevada, United States

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Novartis Investigative Site

Fargo, North Dakota, United States

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Novartis Investigative Site

Columbus, Ohio, United States

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Novartis Investigative Site

Philadelphia, Pennsylvania, United States

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Novartis Investigative Site

Houston, Texas, United States

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Novartis Investigative Site

Bellevue, Washington, United States

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Novartis Investigative Site

Seattle, Washington, United States

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Novartis Investigative Site

Bruges, Belgium, Belgium

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Novartis Investigative Site

Heusden-Zolder, Belgium, Belgium

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Novartis Investigative Site

Uccle, Belgium, Belgium

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Novartis Investigative Site

Kessel-Lo, , Belgium

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Novartis Investigative Site

Mechelen, , Belgium

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Novartis Investigative Site

Santa Fe de Antioquia, Antioquia, Colombia

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Novartis Investigative Site

Antioquia, , Colombia

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Novartis Investigative Site

Århus C, , Denmark

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Novartis Investigative Site

Bamberg, Germany, Germany

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Berlin, Germany, Germany

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Hamburg, Germany, Germany

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Novartis Investigative Site

Ludwigsburg, Germany, Germany

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Novartis Investigative Site

Mainz, Germany, Germany

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Novartis Investigative Site

München, Germany, Germany

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Novartis Investigative Site

Naumburg, Germany, Germany

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Novartis Investigative Site

Nuremberg, Germany, Germany

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Novartis Investigative Site

Wolfsburg, Germany, Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Dresden, , Germany

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Novartis Investigative Site

Freiburg im Breisgau, , Germany

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Novartis Investigative Site

Freiburg im Breisgau, , Germany

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Novartis Investigative Site

Homburg, , Germany

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Novartis Investigative Site

Landau, , Germany

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Novartis Investigative Site

Leipzig, , Germany

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Novartis Investigative Site

Limburg, , Germany

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Novartis Investigative Site

Mannheim, , Germany

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Novartis Investigative Site

Siegen, , Germany

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Novartis Investigative Site

Ulm, , Germany

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Novartis Investigative Site

Westerstede/Oldenburg, , Germany

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Novartis Investigative Site

Würzburg, , Germany

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Novartis Investigative Site

Luleå, , Sweden

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Novartis Investigative Site

Malmo, , Sweden

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Countries

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United States Belgium Colombia Denmark Germany Sweden

References

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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.

Reference Type DERIVED
PMID: 35201607 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25183661 (View on PubMed)

Other Identifiers

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2011-000210-19

Identifier Type: -

Identifier Source: secondary_id

CRIT124D2302E1

Identifier Type: -

Identifier Source: org_study_id