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

NCT ID: NCT01458340

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TD-9855 Dose 1

Group Type: EXPERIMENTAL

TD-9855

Intervention Type: DRUG

Once daily

Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Once daily

TD-9855 Dose 2

Group Type: EXPERIMENTAL

TD-9855

Intervention Type: DRUG

Once daily

Interventions

TD-9855

Once daily

Intervention Type: DRUG

TD-9855

Once daily

Intervention Type: DRUG

Placebo

Once daily

Intervention Type: DRUG

Eligibility Criteria

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.-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theravance Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Florida Clinical Research Center

Maitland, Florida, United States

Janus Ctr. for Psychiatric Research

Palm Beach, Florida, United States

Carman Research

Smyrna, Georgia, United States

Psychiatric Associates

Overland Park, Kansas, United States

Midwest Research Group

Saint Charles, Missouri, United States

Ctr. for Psychiatry & Behavioral Med.

Las Vegas, Nevada, United States

Adult ADHD Program

New York, New York, United States

IPS Research

Oklahoma City, Oklahoma, United States

Summit Research Network

Portland, Oregon, United States

Lincoln Research

Lincoln, Rhode Island, United States

CNS Healthcare of Memphis

Memphis, Tennessee, United States

FutureSearch Clinical Trials

Austin, Texas, United States

Psychiatric & Behavioral Solutions

Salt Lake City, Utah, United States

Lifetree Clinical Research, LC

Salt Lake City, Utah, United States

Summit Research Network (Seattle), LLC

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32856281 (View on PubMed)

Other Identifiers

0085

Identifier Type: -

Identifier Source: org_study_id