Adult Attention Deficit Hyperactivity DisorderPhase 2NCT03324581

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

A Phase 2 study testing OPC-64005 and Atomoxetine in people with Adult Attention Deficit Hyperactivity Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Adult Attention Deficit Hyperactivity Disorder
What is being tested?: OPC-64005 and Atomoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 239 participants
Where: 26 sitesUnited States
Study dates: 9 Nov 2017to 31 Oct 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Southern California Research, LLC
Beverly Hills, California, 90210
Meridien Research
Bradenton, Florida, 34201
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
iResearch Atlanta
Decatur, Georgia, 30030
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526
BTC of Lincoln
Lincoln, Rhode Island, 02865
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Eastside Comprehensive Medical Center, LLC.
New York, New York, 10128
The Medical Research Network, LLC
New York, New York, 10128
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161
IPS Research Company
Oklahoma City, Oklahoma, 73103
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118
Aspen Clinical Research
Orem, Utah, 84058
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Clinical Neuroscience Solutions Inc.
Orlando, Florida, 32806
Psychiatric Associates
Overland Park, Kansas, 66223
Oregon Center for Clinical Investigators, Inc.
Portland, Oregon, 97214
Oregon Center for Clinical Investigators, Inc.
Salem, Oregon, 97301
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Artemis Institute for Clinical Research
San Diego, California, 92103
Artemis Institute for Clinical Research
San Marcos, California, 92078
Neuropsychiatric Associates
Woodstock, Vermont, 05091

Other trials in United States

About this study

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

A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.

Read the detailed description

A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design trial.

Conditions: Adult Attention Deficit Hyperactivity Disorder
Being tested: OPC-64005, Atomoxetine, Placebo
Keywords: ADHD, ADD
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-64005Drug
OPC-64005 film coated tablets
AtomoxetineDrug
Atomoxetine gelatin capsules
PlaceboDrug
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules

Study groups in NCT03324581
Study group	Role	What they receive
OPC-64005	Experimental	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. Receives: Drug: OPC-64005; Drug: Placebo
Atomoxetine	Active comparator	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. Receives: Drug: Atomoxetine; Drug: Placebo
Placebo	Placebo comparator	Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 201731 Oct 2018

First posted27 Oct 2017
Study start9 Nov 2017
Primary completion31 Oct 2018
Study completion31 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adult Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03324581
Sponsor's protocol ID: 277-201-00001
Status last verified: Sep 2021
First submitted: 25 Oct 2017
Last updated: 29 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adult Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03324581
Acronym / sponsor ID: 277-201-00001
Conditions: Adult Attention Deficit Hyperactivity Disorder
Keywords: ADHD, ADD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: 9 Nov 2017 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 31 Oct 2018 (actual)
First posted: 27 Oct 2017 (actual)
Results: Posted 29 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.

Detailed description

A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
OPC-64005	Experimental	Drug: OPC-64005, Drug: PlaceboDuring 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 comparator	Drug: Atomoxetine, Drug: PlaceboDuring 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 comparator	Drug: PlaceboParticipants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-64005OPC-64005 film coated tablets	Drug	OPC-64005
AtomoxetineAtomoxetine gelatin capsules	Drug	Atomoxetine
PlaceboOPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules	Drug	Atomoxetine, OPC-64005, Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 29 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-64005	77	38
Atomoxetine	80	44
Placebo	82	57

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	OPC-64005 n = 76	Atomoxetine n = 74	Placebo n = 77
Baseline	40.71 (6.99)	41.59 (6.66)	40.51 (7.10)
Change at Day 56	-19.4 (17.79)	-20.2 (13.24)	-10.3 (13.52)

OPC-64005 vs Atomoxetine: Difference: 0.81 (95% CI -4.30 to 5.92), p =0.7554, Mixed-effect Model Repeated Measures
OPC-64005 vs Placebo: Difference: -6.61 (95% CI -11.6 to -1.60), p =0.0101, Mixed-effect Model Repeated Measures
Atomoxetine vs Placebo: Difference: -7.42 (95% CI -12.3 to -2.50), p =0.0033, Mixed-effect Model Repeated Measures

Population analysed: Full Analysis Set (FAS) included all randomized participants who took at least one dose of IMP and had a Baseline and at least one post randomization evaluation for the CAARS-O:SV ADHD Symptoms total score (18-items). Number analyzed is the number of participants with data available for analysis at the given time point.

Adverse events

Time frame: From first dose up to 30 days post last dose of study drug (Up to approximately 12 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-64005	1 of 77 (1.3%)	61 of 77 (79.2%)	0 of 77
Atomoxetine	0 of 79 (0%)	59 of 79 (74.7%)	0 of 79
Placebo	0 of 82 (0%)	38 of 82 (46.3%)	0 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Adult Attention Deficit Hyperactivity Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03324581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.