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

NCT00475735 | Completed Phase 2 Results

• 2 other identifiers: 0249-0182007_519
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• 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.

  after 4 weeks of treatment

Secondary Outcomes (6)

• Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment

  after 4 weeks of treatment

• >/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;

  after 4 weeks of treatment

• >/=1-point Improvement in the CGI-S Score

  4 weeks of treatment

• Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score

  4 weeks of treatment

• Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.

  4 weeks of treatment

Other Outcomes (1)

• Baseline AISRS

  Baseline

Study Arms (3)

MK-0249

EXPERIMENTAL

Total time in the study will be \~10 weeks.

Drug: MK0249

Concerta

ACTIVE COMPARATOR

Total time in the study will be \~10 weeks.

Drug: Concerta (methylphenidate)

Placebo

PLACEBO COMPARATOR

Total time in the study will be \~10 weeks.

Drug: Placebo

Interventions

MK0249 DRUG

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.

MK-0249

Concerta (methylphenidate) DRUG

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.

Also known as: CONCERTA®

Concerta

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22901359 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

MK-0249; Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 28, 2015
• Results First Posted: December 10, 2010

Record last verified: 2015-07