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The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT03324581
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Description
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Brief Summary:
A trial to assess the safety and efficacy of OPC-64005 in the treatment of Adult Attention-deficit/Hyperactivity Disorder

Condition or disease Intervention/treatment Phase
Adult Attention Deficit Hyperactivity Disorder Drug: OPC-64005 Drug: Atomoxetine Drug: Placebo Phase 2

Detailed Description:
A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Active- and Placebo-controlled Trial of the Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OPC-64005
20 mg tablet dose, titrated up to a max of 30 mg, daily, oral
 Drug: OPC-64005
Tablet
Active Comparator: Atomoxetine
40 mg capsule titrated up to 80 mg, daily, oral
 Drug: Atomoxetine
Capsule
Placebo Comparator: Placebo
tablet/capsule, daily, oral
 Drug: Placebo
Tablet/Capsule


Outcome Measures
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Primary Outcome Measures :
  1. Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) [Efficacy] [ Time Frame: Up to 56 days or early termination ]
    18-item ADHD symptom score will be assessed to compare experimental group to active comparator; Total Score: Min score: 0, Max score: 54. Individual item scores: Min score: 0, max score: 3. Best outcome - Score = 0, Worse outcome - Score = 3. Total score is sum of individual scores.


Other Outcome Measures:
  1. CAARS-O:SV [ Time Frame: Up to 56 days or early termination ]
    Change in score will be assessed on experimental versus active comparator & placebo. Total Score: Minimum: 0, Maximum: 54. Individual Score: Minimum: 0, Maximum: 3. Score of 0 is best outcome, score of 3 is worse outcome. Total score is sum of individual scores.

  2. Adult ADHD Investigator Symptom Rating Scale (AISRS) With Adult Prompts [ Time Frame: Up to 56 days or early termination ]
    Change in score will be assessed on experimental versus active comparator & placebo. Total Score: Minimum: 0, maximum: 54. Individual scores: minimum: 0, maximum: 3. Score of 0 is best outcome, score of 3 is worse outcome. Total score is sum of individual scores.

  3. Clinical Global Impression -Severity of Illness Scale (CGI-S) Score [ Time Frame: Up to 56 days or early termination ]
    Change in score will be assessed on experimental versus active comparator & placebo. Minimum Score: 1, Maximum Score: 7. Score of 1 is best outcome, score of 7 is worse outcome.

  4. Clinical Global Impression - Global Improvement Scale (CGI-I) Score [ Time Frame: Up to 56 days or early termination ]
    Change in score will be assessed on experimental versus active comparator & placebo. Minimum Score: 1, Maximum Score: 7. Score of 1 is best outcome, score of 7 is worse outcome.

  5. Conners' Adult ADHD Rating Scales-Self-Report: Screening Version (CAARS-S:SV) [ Time Frame: Up to 56 days or early termination ]
    Change in score will be assessed on experimental versus active comparator & placebo. Total Score: Minimum: 0, Maximum: 54. Individual Score: Minimum: 0, Maximum: 3. Score of 0 is best outcome, score of 3 is worse outcome. Total score is sum of individual scores.

  6. Adult ADHD Quality of Life Scale (AAQoL) [ Time Frame: Up to 56 days or early termination ]
    Change in score will be assessed on experimental versus active comparator & placebo. 6 item scale; Individual Score: Minimum: 1, Maximum: 5 additional option of "not applicable" for 1 sub-question. Outcome measure vary by question, some will be: 1 - best outcome, 5 - worse outcome; others will be 1 - worse outcome, 5 - best outcome.

  7. Drug Effects Questionnaire (DEQ) [ Time Frame: Up to 56 days or early termination ]
    Change in score will be assessed on experimental versus active comparator & placebo to determine potential for abuse liability and dependence. Visual analog scale from 0 to 100. Scale is not quantifiable by "better" or "worse" as it is a subjective question on the subject's feelings about the medication.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Screening):

  • Male and female outpatients 18 to 55 years of age, inclusive, at the time of informed consent.
  • Subjects with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of ADHD (including predominantly inattentive presentation, hyperactive presentation, and combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) v 1.2.
  • Subjects willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and up to the 30 (+ 2)-day follow-up period.

Exclusion Criteria:

  • Subjects with a history of inadequate response or suboptimal tolerability to atomoxetine.
  • Subjects who report allergies (lifetime treatment history) to stimulant or nonstimulant ADHD medications.
  • Subjects with other DSM-5 disorders including psychosis (current or lifetime), bipolar disorder (current or lifetime), current major depressive disorder, or current panic disorder; or another psychiatric diagnosis that the investigator believes is primary or that will confound efficacy or safety assessments of the trail or interfere with participation in the trial otherwise.
  • Subjects with a clinically significant current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, histrionic, narcissistic, avoidant, obsessive compulsive, or dependent personality disorders.
  • Subjects who currently have clinically significant dermatological, neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or active or chronic hepatitis B or C.
  • Subjects with a history of obstructive sleep apnea.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324581


Locations
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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03324581    
Other Study ID Numbers: 277-201-00001
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
ADHD
ADD
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs