A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder



Status:Recruiting
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:2/17/2019
Start Date:January 16, 2019
End Date:May 2020

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

This study evaluates the efficacy, safety, and tolerability of centanafadine
sustained-release tablets in adults with ADHD. Patients will either receive a twice-daily
dose of centanafadine sustained-release tablets, or twice-daily placebo.

Screening & Washout Period: up to 28 days Investigational Treatment Period: 49 days Follow-up
Period : 7 days or 10 days

Inclusion Criteria:

- Subjects must meet the Diagnostic and Statistical Manual of Mental Disorders Fifth
Edition (DSM-5) criteria for ADHD (including predominantly inattentive presentation,
hyperactive presentation, or combined presentation) as confirmed by the Adult ADHD
Clinical Diagnostic Scale (ACDS) Version 1.2. To confirm that ADHD is the primary
diagnosis, the Mini International Neuropsychiatric Interview (MINI) will be used to
identify and exclude other psychiatric conditions which would preclude enrollment.

- Subjects who were not receiving any pharmacological treatment for ADHD must have an
Adult ADHD Investigator Symptom Rating Scale (AISRS) score of ≥ 28 at screening and
baseline. Subjects who were receiving pharmacological treatment for ADHD at screening
must have a minimum AISRS score of ≥ 22 at screening, and a score of ≥ 28 at baseline.

- All subjects must be willing to discontinue all prohibited psychotropic medications
starting from the time of signing the informed consent through the 7-day follow-up
period. Subjects that do not rollover into Trial 405-201-00015 must be willing to
discontinue all prohibited psychotropic medications starting from the time of signing
the informed consent until after the follow-up telephone call 10 days after the last
dose of IMP.

- Subjects must have a Clinical Global Impression-Severity of Illness Scale (CGI-S)
score of ≥ 4 (≥ moderate impairment) at baseline.

Exclusion Criteria:

- Subjects with a DSM-5 diagnosis of Other Specified or Unspecified Attention
Deficit/Hyperactivity Disorder.

- Subject has a current comorbid psychiatric disorder that either could be expected to
require treatment with medications prohibited in this trial, or to confound efficacy
or safety assessments. Examples include, but are not limited to, psychotic disorder,
bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, panic
disorder, a current major depressive episode, or posttraumatic stress disorder, as
established by the Mini International Neuropsychiatric Interview (MINI).

- In the opinion of the investigator, subject has not derived significant therapeutic
benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and
methylphenidate) given with an acceptable dose and duration during adulthood (aged 18
or older). NOTE: If subject has not derived significant therapeutic benefit due to an
inability to tolerate side effects, eligibility can be discussed on case-by-case basis
with the medical monitor.

- Subjects that have a positive alcohol test (via breathalyzer or blood), a positive
drug screen for cocaine, or other illicit drugs (excluding marijuana). Subjects with a
positive drug screen for confirmed prescription or over-the-counter (OTC) use of ADHD
medications at screening will be required to undergo a washout period. NOTE: Subjects
that test positive for marijuana may be permitted to be enrolled if they have no
evidence of a substance use disorder, and if they agree to refrain from use for the
duration of the trial. Allowance for subjects testing positive for marijuana at
screening require explicit approval from the medical monitor.

- In the opinion of the investigator, the subject is unable to adhere to the treatment
regimen or other requirements outlined in the protocol.
We found this trial at
30
sites
Baltimore, Maryland 21208
Phone: 410-602-1440
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Austin, Texas 78737
Phone: 512-898-9362
?
mi
from
Austin, TX
Click here to add this to my saved trials
2026 Wirt Road
Bellaire, Texas 77401
Phone: 713-527-8839
?
mi
from
Bellaire, TX
Click here to add this to my saved trials
Berlin, New Jersey
Phone: 856-753-7335
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
Cedarhurst, New York 11516
Phone: 516-295-7230
?
mi
from
Cedarhurst, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28210
Phone: 800-785-3150
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
Phone: 719-634-6576
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Coral Springs, Florida 33067
Phone: 954-796-8222
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
Culver City, California 90230
Phone: 424-227-8127
?
mi
from
Culver City, CA
Click here to add this to my saved trials
Garden Grove, California 92845
Phone: 714-799-7799
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Hialeah, Florida 33012
Phone: 786-536-4177
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Jacksonville, Florida 32216
Phone: 904-281-5757
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89128
Phone: 702-838-0742
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Libertyville, Illinois 60048
Phone: 847-549-7214
?
mi
from
Libertyville, IL
Click here to add this to my saved trials
Maitland, Florida 32751
Phone: 407-644-1165
?
mi
from
Maitland, FL
Click here to add this to my saved trials
Memphis, Tennessee 38119
Phone: 901-843-1045
?
mi
from
Memphis, TN
Click here to add this to my saved trials
11750 Southwest 40th Street
Miami, Florida 33175
Phone: 786-600-0012
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
Phone: 843-856-3784
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
New York, New York 10168
Phone: 212-772-3570
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
Phone: 949-752-7910
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
O'Fallon, Missouri 63368
Phone: 636-244-3593
?
mi
from
O'Fallon, MO
Click here to add this to my saved trials
Oceanside, California 92056
Phone: 760-639-4378
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Orlando, Florida 32806
Phone: 407-425-5100
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27609
Phone: 919-872-5900
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Redlands, California 92374
Phone: 909-792-9007
?
mi
from
Redlands, CA
Click here to add this to my saved trials
Richardson, Texas 75080
Phone: 214-396-4844
?
mi
from
Richardson, TX
Click here to add this to my saved trials
Salem, Oregon 97301
Phone: 503-540-0100
?
mi
from
Salem, OR
Click here to add this to my saved trials
San Diego, California 92123
Phone: 858-278-3647
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Tampa, Florida 33634
Phone: 813-877-8839
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Upland, California 91786
Phone: 909-920-3000
?
mi
from
Upland, CA
Click here to add this to my saved trials