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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03324581
Recruitment Status : Completed
First Posted : October 27, 2017
Results First Posted : October 29, 2021
Last Update Posted : October 29, 2021
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 9, 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
During the titration period, participants received OPC-64005 two 10 milligram (mg) tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, once daily (QD), from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable.
 Drug: OPC-64005
OPC-64005 film coated tablets

Drug: Placebo
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Active Comparator: Atomoxetine

During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4.

During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable.

 Drug: Atomoxetine
Atomoxetine gelatin capsules

Drug: Placebo
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Placebo Comparator: Placebo
Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.
 Drug: Placebo
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) 18-item ADHD Symptoms Total Score at Day 56 [ Time Frame: Baseline, Day 56 ]
    The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). It includes a 9-item inattentive symptom subscale and a 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of individual scores and can range from 0 to 54. Higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement.


Other Outcome Measures:
  1. Change From Baseline in CAARS-O:SV 18-item Score on Days 7, 14, 21, 28, 42, and 56 [ Time Frame: Baseline, Days 7, 14, 21, 28, 42, and 56 ]
    The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. It includes a 9-item inattentive symptom subscale and a 9- item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of individual scores and can range from 0 to 54. Higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement.

  2. Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) With Adult Prompts Score on Day 28 and Day 56 [ Time Frame: Baseline, Days 28 and 56 ]
    The AISRS consists of 18-items derived from DSM-IV criteria for ADHD symptoms. The AISRS total score is the sum of the 9-item inattentive symptoms subscale and 9-item hyperactive and impulsive symptoms subscale. Each item is scored as follows: 0=none, 1=mild, 2=moderate, and 3=severe. The score for each subscale can range from 0 to 27. The total score can range from 0 to 54. A negative change from Baseline indicates improvement.

  3. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score on Days 7, 14, 21, 28, 42, and 56 [ Time Frame: Baseline, Days 7, 14, 21, 28, 42, and 56 ]
    The CGI-S evaluates the severity of individual symptoms and treatment response in participants with mental disorders. It is a 7-point scale that that requires the clinician to rate the severity of the participant's illness at the time of assessment as 0=not assessed, 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants. The score 0=not assessed was set to missing. A negative change from Baseline indicates improvement.

  4. Clinical Global Impression-Improvement (CGI-I) Score on Days 7, 14, 21, 28, 42, and 56 [ Time Frame: Baseline, Days 7, 14, 21, 28, 42, and 56 ]
    The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention and rated as: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The score of 0 =not assessed was set to missing. Lower scores indicate improvement.

  5. Change From Baseline in Conners' Adult ADHD Rating Scales-Self-Report: Screening Version (CAARS-S:SV) 18-item Total Score on Days 7, 14, 21, 28, 42, and 56 [ Time Frame: Baseline, Days 7, 14, 21, 28, 42, and 56 ]
    The CAARS-S:SV comprises of 30 items to measure symptoms for ADHD in adults but was limited to the 18 DSM-5 criteria relevant items for this trial. The 18-item ADHD Symptoms total score is the sum of the 9-item inattentive symptoms subscale and the 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. Total score can range from 0 to 54. A negative change from Baseline indicates improvement.

  6. Change From Baseline in Adult ADHD Quality of Life Scale (AAQoL) Total Score on Day 28 and Day 56 [ Time Frame: Baseline, Days 28, and 56 ]
    The AAQoL is a validated, 29-item instrument for measuring the impact of ADHD symptoms on quality of life. The scale assesses 4 distinct functional domains based on the following subscales: life productivity (11 items), psychological health (6 items), life outlook (7 items), and relationships (5 items). Scores for individual items range from 1=never/not at all to 5=extremely/very often. Total and subscale scores were computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. Higher scores indicate a greater impact.

  7. OPC-64005 Potential for Abuse Liability and Dependence as Assessed by the Drug Effects Questionnaire (DEQ) Score [ Time Frame: Baseline, Days 7, 14, 21, 28, 42, and 56 ]
    The DEQ was used to assess the potential for abuse of OPC-64005. It is a 5-item questionnaire completed by the participant that includes the following questions: 1. Do you feel a drug effect right now? 2. Are you high right now? 3. Do you dislike any of the effects you are feeling right now? 4. Do you like any of the effects you are feeling right now? 5. would you like more of the drug you took, right now? Each item is rated on a 100-point scale of 1 (not at all) to 100 (extremely). 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.


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 participants 18 to 55 years of age, inclusive, at the time of informed consent.
  • Participants 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.
  • Participants 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:

  • Participants with a history of inadequate response or suboptimal tolerability to atomoxetine.
  • Participants who report allergies (lifetime treatment history) to stimulant or nonstimulant ADHD medications.
  • Participants 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.
  • Participants with a clinically significant current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, histrionic, narcissistic, avoidant, obsessive compulsive, or dependent personality disorders.
  • Participants 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 (human immunodeficiency virus) seropositive status/acquired immunodeficiency syndrome, or active or chronic hepatitis B or C.
  • Participants 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.
  Study Documents (Full-Text)

Documents provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Study Protocol  [PDF] August 28, 2017
Statistical Analysis Plan  [PDF] June 20, 2018

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
Results First Posted: October 29, 2021
Last Update Posted: October 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
URL: https://clinical-trials.otsuka.com

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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