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

NCT ID: NCT00475735

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-04-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-0249

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

Group Type: EXPERIMENTAL

MK0249

Intervention Type: 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.

Concerta

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

Group Type: ACTIVE_COMPARATOR

Concerta (methylphenidate)

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

CONCERTA®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: BACKGROUND

PMID: 22901359 (View on PubMed)

Other Identifiers

2007_519

Identifier Type: -

Identifier Source: secondary_id

0249-018

Identifier Type: -

Identifier Source: org_study_id