A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00475735

Purpose

The purpose of this study is to investigate the safety and efficacy of an investigational treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.

Condition	Intervention	Phase
Attention-Deficit/Hyperactivity Disorder (ADHD)	Drug: MK0249 Drug: Comparator: methylphenidate Drug: Comparator: Placebo (unspecified)	Phase II

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Incomplete Block, Two-Period, Crossover Clinical Trial to Study the Safety and Efficacy of MK0249, 10 mg, for Adult Patients, Ages 18 to 55, With Attention Deficit Hyperactivity Disorder (ADHD)

Further study details as provided by Merck:

Primary Outcome Measures:

mean change from baseline in the AISRS total score after 4 weeks of treatment [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

>/= 30% AISRS total score responder rate after 4 weeks of treatment; mean change from baseline in the AISRS inattentive subscale score after 4 weeks of treatment [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	48
Study Start Date:	July 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: drug	Drug: MK0249 MK0249 5mg tablet bid. Total time in the study will be ~10 weeks. Drug: Comparator: Placebo (unspecified) Methylphenidate 18mg encapsulated Pbo tablet up to qid. Total time in the study will be ~10 weeks.
2: Active Comparator Arm 2: Active comparator	Drug: Comparator: methylphenidate methylphenidate 18mg encapsulated tablet up to qid. Total time in the study will be ~10 weeks. Drug: Comparator: Placebo (unspecified) MK0249 5mg Pbo tablet bid. Total time in the study will be ~10 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is between 18 and 55 years of age (inclusive)
Patient is an adult with a current DSM-IV diagnosis of ADHD of inattentive or combined subtype, as assessed via a structured interview using the ACDS and AISRS
Females of child-bearing potential must use acceptable methods of birth control during the study and for 1 month post-therapy

Exclusion Criteria:

Patient has a history of a neurological disorder resulting in ongoing impairment
Patient has a lifetime history of a psychotic disorder, bipolar disorder, or post-traumatic stress disorder
Patient has evidence of ongoing depression
Patient is sensitive or allergic to methylphenidate
Patient has glaucoma
Patient has a previous history of narrowing or blockage of the GI tract
Patient has a history of a sleep disorder (e.g., insomnia, sleep apnea, nightmares, or night terrors) within 6 months prior to screening
Patient has a history of a cardiovascular disorder within 6 months prior to screening
Patient has moderate or severe persistent asthma
Patient has a history of substance abuse or dependence not in sustained full remission for at least one year according to DSM-IV
Patient has taken part in a research study within the past 30 days of signing informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475735

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_519, MK0249-018
Study First Received:	May 17, 2007
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00475735
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009