Back to resultsA Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
Primary Purpose
Attention-Deficit/Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0249
Concerta (methylphenidate)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder (ADHD)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
MK-0249
Concerta
Placebo
Arm Description
Total time in the study will be ~10 weeks.
Total time in the study will be ~10 weeks.
Total time in the study will be ~10 weeks.
Outcomes
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
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
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;
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
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
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00475735
Brief Title
A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder (ADHD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK-0249
Arm Type
Experimental
Arm Description
Total time in the study will be ~10 weeks.
Arm Title
Concerta
Arm Type
Active Comparator
Arm Description
Total time in the study will be ~10 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Total time in the study will be ~10 weeks.
Intervention Type
Drug
Intervention Name(s)
MK0249
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Concerta (methylphenidate)
Other Intervention Name(s)
CONCERTA®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment
Description
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.
Time Frame
after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment
Description
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.
Time Frame
after 4 weeks of treatment
Title
>/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;
Description
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.
Time Frame
after 4 weeks of treatment
Title
>/=1-point Improvement in the CGI-S Score
Description
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.
Time Frame
4 weeks of treatment
Title
Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score
Description
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
Time Frame
4 weeks of treatment
Title
Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.
Description
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.
Time Frame
4 weeks of treatment
Title
Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score
Description
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.
Time Frame
4 weeks of treatment
Other Pre-specified Outcome Measures:
Title
Baseline AISRS
Description
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).
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22901359
Citation
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.
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A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
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