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Efficacy and Safety Study of Methylphenidate Hydrochloride Modified Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01259492
First received: December 11, 2010
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

This study will evaluate efficacy and safety of methylphenidate hydrochloride modified release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).


Condition Intervention Phase
Attention Deficit/Hyperactivity Disorder
 Drug: Placebo
Drug: RIT124D
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate HCl Modified Release in the Treatment of Adult Patients With Childhood-onset ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Attention Deficit/Hyperactivity Disorder Rating Scale total score [ Time Frame: End of Week 9 ] [ Designated as safety issue: No ]
  • Total score on Sheehan Disability Scale [ Time Frame: End of Week 9 ] [ Designated as safety issue: No ]
  • Percentage of treatment failures [ Time Frame: at 40 weeks (end of withdrawal period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients with clinical improvement on Clinical Global Impression-Improvement Scale. [ Time Frame: End of Week 9 ] [ Designated as safety issue: No ]

Enrollment: 700
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo Comparator: Placebo
Experimental: Methylphenidate hydrochloride modified release 40 mg Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg
Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg
Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg
Experimental: Methylphenidate hydrochloride modified release 60 mg Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg
Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg
Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg
Experimental: Methylphenidate hydrochloride modified release 80 mg Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg
Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg
Drug: RIT124D
Experimental: Methylphenidate hydrochloride modified release 40 mg

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259492

  Show 67 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01259492     History of Changes
Other Study ID Numbers: CRIT124D2302, 2010-021533-31
Study First Received: December 11, 2010
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Singapore: Health Sciences Authority
South Africa: Medicines Control Council

Keywords provided by Novartis:
Attention Deficit /Hyperactivity Disorder, hyperactivity

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013