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 28, 2013
Last verified: August 2013

May 17, 2007
August 28, 2013
July 2007
April 2008   (final data collection date for primary outcome measure)
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.
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Complete list of historical versions of study NCT00475735 on ClinicalTrials.gov Archive Site
  • 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.

Proprietary Information - Exploratory (Non-Confirmatory) Trial
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).
Not Provided
 
A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder (ADHD)
  • 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.
  • 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®
  • 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.
  • Experimental: MK-0249
    Total time in the study will be ~10 weeks.
    Intervention: Drug: MK0249
  • Active Comparator: Concerta
    Total time in the study will be ~10 weeks.
    Intervention: Drug: Concerta (methylphenidate)
  • Placebo Comparator: Placebo
    Total time in the study will be ~10 weeks.
    Intervention: Drug: Placebo
Herring WJ, Wilens TE, Adler LA, Baranak C, Liu K, Snavely DB, Lines CR, Michelson D. Randomized controlled study of the histamine H3 inverse agonist MK-0249 in adult attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Jul;73(7):e891-8. doi: 10.4088/JCP.11m07178.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00475735
0249-018, 2007_519
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP