A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT01458340 | Completed Phase 2 Results

• 1 other identifier: 0085
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Attention-Deficit/Hyperactivity Disorder; ADHD

Keywords

Adult ADHD; Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in AISRS Total Score at Day 42

  The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.

  Baseline and Day 42

Secondary Outcomes (12)

• Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42

  Baseline and Day 42

• Change From Baseline in AISRS Inattentive Subscale at Day 42

  Baseline and Day 42

• Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42

  Baseline and Day 42

• Percentage of Participants With an AISRS Response at Day 42

  Day 42

• Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42

  Baseline and Day 42

Study Arms (3)

TD-9855 Dose 1

EXPERIMENTAL

Drug: TD-9855

Placebo

EXPERIMENTAL

Drug: Placebo

TD-9855 Dose 2

EXPERIMENTAL

Drug: TD-9855

Interventions

TD-9855 DRUG

Once daily

TD-9855 Dose 1

Placebo DRUG

Once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (17)

Florida Clinical Research Center, LLC

Bradenton, Florida, 34201, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Florida Clinical Research Center

Maitland, Florida, 34201, United States

Location

Janus Ctr. for Psychiatric Research

Palm Beach, Florida, 33407, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Ctr. for Psychiatry & Behavioral Med.

Las Vegas, Nevada, 89128, United States

Location

Adult ADHD Program

New York, New York, 10016, United States

Location

IPS Research

Oklahoma City, Oklahoma, 73103, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Lincoln Research

Lincoln, Rhode Island, 02865, United States

Location

CNS Healthcare of Memphis

Memphis, Tennessee, 38119, United States

Location

FutureSearch Clinical Trials

Austin, Texas, 78731, United States

Location

Psychiatric & Behavioral Solutions

Salt Lake City, Utah, 84105, United States

Location

Lifetree Clinical Research, LC

Salt Lake City, Utah, 84106, United States

Location

Summit Research Network (Seattle), LLC

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 32856281 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

ampreloxetine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Monitor
• Organization: Theravance Biopharma

medinfo@theravance.com

1-855-633-8479

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 4, 2022
• Results First Posted: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)