The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
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
1 other identifier
interventional
239
1 country
26
Brief Summary
A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2017
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2017
CompletedFirst Posted
Study publicly available on registry
October 27, 2017
CompletedStudy Start
First participant enrolled
November 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedResults Posted
Study results publicly available
October 29, 2021
CompletedOctober 29, 2021
September 1, 2021
12 months
October 25, 2017
September 30, 2021
September 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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.
Baseline, Day 56
Other Outcomes (7)
Change From Baseline in CAARS-O:SV 18-item Score on Days 7, 14, 21, 28, 42, and 56
Baseline, Days 7, 14, 21, 28, 42, and 56
Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) With Adult Prompts Score on Day 28 and Day 56
Baseline, Days 28 and 56
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score on Days 7, 14, 21, 28, 42, and 56
Baseline, Days 7, 14, 21, 28, 42, and 56
- +4 more other outcomes
Study Arms (3)
OPC-64005
EXPERIMENTALDuring 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.
Atomoxetine
ACTIVE COMPARATORDuring 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.
Placebo
PLACEBO COMPARATORParticipants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.
Interventions
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Southern California Research, LLC
Beverly Hills, California, 90210, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Artemis Institute for Clinical Research
San Marcos, California, 92078, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910, United States
Meridien Research
Bradenton, Florida, 34201, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions Inc.
Orlando, Florida, 32806, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
Psychiatric Associates
Overland Park, Kansas, 66223, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526, United States
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128, United States
Eastside Comprehensive Medical Center, LLC.
New York, New York, 10128, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118, United States
Oregon Center for Clinical Investigators, Inc.
Portland, Oregon, 97214, United States
Oregon Center for Clinical Investigators, Inc.
Salem, Oregon, 97301, United States
BTC of Lincoln
Lincoln, Rhode Island, 02865, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2017
First Posted
October 27, 2017
Study Start
November 9, 2017
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
October 29, 2021
Results First Posted
October 29, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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/
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.