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

Attention Deficit/Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338818
• Other study ID #: CRIT124D2302E1
• Secondary ID: 2011-000210-19
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2011
• Last updated: November 4, 2014
• Start date: April 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Institute for Drugs and Medical DevicesNorway: Norwegian Medicines AgencyDenmark: Danish Medicines AgencySweden: Medical Products AgencySingapore: Health Sciences AuthoritySouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Heusden-Zolder
Belgium	Novartis Investigative Site	Kessel-Lo
Belgium	Novartis Investigative Site	Mechelen
Belgium	Novartis Investigative Site	Uccle
Colombia	Novartis Investigative Site	Antioquia
Colombia	Novartis Investigative Site	Antioquia
Denmark	Novartis Investigative Site	Århus C
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Landau
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Limburg
Germany	Novartis Investigative Site	Ludwigsburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Naumburg
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Westerstede/Oldenburg
Germany	Novartis Investigative Site	Wolfsburg
Germany	Novartis Investigative Site	Würzburg
Sweden	Novartis Investigative Site	Luleå
Sweden	Novartis Investigative Site	Malmö
United States	Novartis Investigative Site	Bellevue	Washington
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Fargo	North Dakota
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Libertyville	Illinois
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Spring Valley	California
United States	Novartis Investigative Site	West Plam Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Colombia,  Denmark,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("rarely or never") to 3 ("Very often"). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing.	week 40 - week 66	No
Secondary	Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score	SDS,5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.	week 40 - week 66	No