Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

NCT00776009 | Completed Phase 4 Results

• 1 other identifier: CRIT124EUS21
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 8

Brief Summary

This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHD, children, subjects, laboratory classroom

Outcome Measures

Primary Outcomes (1)

• Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose

  SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.

  Pre-dose to 10, 11, and 12 hours post-dose

Secondary Outcomes (4)

• Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose

  Pre-dose to 10, 11, and 12 hours post-dose

• Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose

  Pre-dose to 10, 11, and 12 hours post-dose

• Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose

  Pre-dose to 10, 11, and 12 hours post-dose

• Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose

  Pre-dose to 10, 11, and 12 hours post-dose

Study Arms (3)

Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg

EXPERIMENTAL

Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days.

Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg

ACTIVE COMPARATOR

Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days.

Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

Placebo

PLACEBO COMPARATOR

Two Capsules taken orally once a day for 7 days

Drug: Placebo

Interventions

Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) DRUG

10 mg and/or 20 mg capsules

Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg; Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg

Placebo DRUG

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects aged 6-12 years, inclusive.
• Subjects meeting the DSM-IV criteria for primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
• Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to Screening visit.

You may not qualify if:

• Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
• Diagnosed with or history of a tic disorder or Tourette's syndrome.
• History of seizure disorder.
• The presence of a known medical condition that would preclude the use of methylphenidate.
• A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease.
• ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of Normal) at Screening.
• A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
• Subjects who have participated in an investigational trial within the past 4 weeks (28 days)
• Subjects who are currently taking antidepressants or other psychotropic medication.
• Subjects who have initiated psychotherapy during the three months prior to randomization.
• Subjects with a positive urine drug screen.
• Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Clinical Study Center, LLC

Little Rock, Arkansas, 72205, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Bayou City Research

Houston, Texas, 77007, United States

Location

Claghorn-Lesem Research Clinic

Houston, Texas, 77008, United States

Location

Behavioral Neurology

Lubbock, Texas, 79423, United States

Location

Related Publications (1)

• Brams M, Turnbow J, Pestreich L, Giblin J, Childress A, McCague K, Muniz R. A randomized, double-blind study of 30 versus 20 mg dexmethylphenidate extended-release in children with attention-deficit/hyperactivity disorder: late-day symptom control. J Clin Psychopharmacol. 2012 Oct;32(5):637-44. doi: 10.1097/JCP.0b013e3182677825.

  PMID: 22926597 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 8, 2011
• Results First Posted: March 16, 2011

Record last verified: 2011-06

Locations

US (8)