A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00475735
First received: May 17, 2007
Last updated: August 6, 2014
Last verified: August 2014
  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: Concerta (methylphenidate)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
    The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.


Secondary Outcome Measures:
  • 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: No ]

    The AISRS inattentive subscale score consists of 9 items from the original ADHD-RS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.

    Data not reported due to failure of primary hypothesis and program termination.


  • >/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment; [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

    The AISRS total score consists of 18 items from the original ADHD-RS which were derived based on DSM-IV criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.

    Data not reported due to failure of primary hypothesis and program termination.


  • >/=1-point Improvement in the CGI-S Score [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]

    The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.

    Data not reported due to failure of primary hypothesis and program termination.


  • Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]

    The Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) hyperactive/impulsive subscale score consists of 9 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.

    Data not reported due to failure of primary hypothesis and program termination


  • Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score. [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]

    Conners' Adult ADHD Rating Scale - Observer Screening version (CAARS-O: SV) evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. It is a 30-item scale administered by a trained investigator or rater with "cue" questions. Each item is scored from 0 to 3 with higher scores corresponding to worse symptoms. The total score can range from 0 to 90.

    Data not reported due to failure of primary hypothesis and program termination.


  • Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]

    The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.

    Data not reported due to failure of primary hypothesis and program termination.



Other Outcome Measures:
  • Baseline AISRS [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    Baseline values for all treatment groups are equal because

    the constrained longitudinal data analysis (cLDA) model was used

    (Liang and Zeger, 2000, Sankhyā: The Indian Journal of Statistics, Series B 62, 134-148).



Enrollment: 72
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0249
Total time in the study will be ~10 weeks.
Drug: MK0249
MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
Active Comparator: Concerta
Total time in the study will be ~10 weeks.
Drug: Concerta (methylphenidate)
Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
Other Name: CONCERTA®
Placebo Comparator: Placebo
Total time in the study will be ~10 weeks.
Drug: Placebo
For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00475735     History of Changes
Other Study ID Numbers: 0249-018, 2007_519
Study First Received: May 17, 2007
Results First Received: October 13, 2010
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

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
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014