Clinical trial NCT01458340: A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Proof-of-Concept Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
ADHD
Keywords: Adult ADHD
Attention-Deficit/Hyperactivity Disorder
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.


Eligibility criteria: Inclusion Criteria:

* Subjects must meet the following ADHD diagnostic and inclusion criteria:
* Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by Adult Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2).
* Subjects must have a total score of 24 or greater on the AISRS at both the Screening and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20% from Screening.
* Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms.
* For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0. All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing.
* A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device \[IUD\] with documented failure rate of \<1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with a barrier method.
* Women are considered to be not of childbearing potential if they have had a total hysterectomy or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal. Female subjects cannot be breast-feeding.

Exclusion Criteria:

Any current psychiatric disorder other than ADHD as defined in DSM-IV-TR as assessed by Mini International Neuropsychiatric Interview (MINI). Subjects with dysthymia that does not require pharmacological treatment will not be excluded.

* MADRS total score \>15.
* A diagnosis of ADHD NOS.
* Any diagnosis of lifetime bipolar disorder or psychotic disorder
* A current diagnosis of any severe comorbid Axis II disorder
* Any history of mental retardation, organic mental disorders due to general medical condition or pervasive developmental disorder as defined by DSM-IV-TR.-

Primary outcomes:
measure: Change From Baseline in AISRS Total Score at Day 42
timeFrame: Baseline and Day 42
Secondary outcomes:
measure: Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42
timeFrame: Baseline and Day 42
measure: Change From Baseline in AISRS Inattentive Subscale at Day 42
timeFrame: Baseline and Day 42
measure: Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42
timeFrame: Baseline and Day 42
measure: Percentage of Participants With an AISRS Response at Day 42
timeFrame: Day 42
measure: Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42
timeFrame: Baseline and Day 42
measure: Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42
timeFrame: Baseline and Day 42
measure: Change From Baseline in ASRS Inattentive Subscale at Day 42
timeFrame: Baseline and Day 42
measure: Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42
timeFrame: Baseline and Day 42
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42
timeFrame: Baseline and Day 42
measure: Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42
timeFrame: Baseline and Day 42
measure: Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42
timeFrame: Baseline and Day 42
measure: Change From Baseline in BDEFS-SF Symptom Count at Day 42
timeFrame: Baseline and Day 42
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Palm Beach
country: United States
facility: Janus Ctr. for Psychiatric Research
state: Florida
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Las Vegas
country: United States
facility: Ctr. for Psychiatry & Behavioral Med.
state: Nevada
city: New York
country: United States
facility: Adult ADHD Program
state: New York
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Memphis
country: United States
facility: CNS Healthcare of Memphis
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: Psychiatric & Behavioral Solutions
state: Utah
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research, LC
state: Utah
city: Seattle
country: United States
facility: Summit Research Network (Seattle), LLC
state: Washington
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.