Dasotraline Adult ADHD Study

NCT02276209 | Completed Phase 3 DMC

• 1 other identifier: SEP360-301
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 59

Brief Summary

This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD.

Conditions

Adult Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline at Week 8 in ADHD symptoms measured by the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score.

  8 Weeks

Secondary Outcomes (28)

• Change from baseline in ADHD symptoms measured with the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score at Weeks 1, 2, 4, and 6.

  8 Weeks

• Change from baseline in the inattentiveness and hyperactivity-impulsivity subscale scores of the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts at Weeks 1, 2, 4, 6, and 8.

  8 Weeks

• Change from baseline in Clinical Global Impression - Severity scale (CGI S) scale at Weeks 1, 2, 4, 6, and 8.

  8 Weeks

• Change from baseline in Sheehan Depression Scale (SDS) total score at Weeks 4 and 8.

  8 Weeks

• Change from baseline in Sheehan Depression Scale (SDS) domain scores: work/school, family life, social life at Weeks 4 and 8.

  8 Weeks

Study Arms (3)

Dasotraline 4 mg

EXPERIMENTAL

Dasotraline 4 mg once daily

Drug: Dasotraline

Dasotraline 6 mg

EXPERIMENTAL

Dasotraline 6 mg once daily

Drug: Dasotraline

Placebo

PLACEBO COMPARATOR

Placebo once daily

Other: Placebo

Interventions

Dasotraline DRUG

Dasotraline 4 mg once daily

Dasotraline 4 mg

Placebo OTHER

Placebo once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is male or female, 18 to 55 years old, inclusive, at the time of informed consent.
• Subject has an ADHD RS IV with adult prompts total score of ≥ 26 at screening and at Baseline.
• Subject has a CGI S score of ≥ 4 at screening and at Baseline.
• Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug at screening.
• If the subject has a positive drug screen for ADHD medications (eg, amphetamine) at screening, the subject must have a negative repeat UDS at least 7 days before baseline.
• Subject is male or a non pregnant, non lactating female.
• Female subjects must have a negative serum pregnancy test at screening; females who are post menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
• Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use an effective and medically acceptable form of birth control, as defined in Section 10.4, throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
• Subject must have a stable living arrangement that allows for consistent participation for the full duration of the study.
• Subject must be able to comply with study medication administration and adhere to protocol requirements.
• Subject can read well enough to understand the informed consent form and other subject materials.
• Subjects must complete a practice trial for the TASS assessment at one timepoint during Screening.

You may not qualify if:

• Subject has a ≥ 25% improvement on the ADHD RS IV total score between screening and baseline.
• Subject has a psychiatric disorder other than ADHD that has been the primary focus of treatment at any time during the 12 months before screening.
• Subject has a past history of, or current presentation consistent with, bipolar disorder (including bipolar I and bipolar II), schizophrenia, schizoaffective disorder, or any other psychotic disorder; a personality disorder per DSM 5 criteria.
• Subject has a history of drug dependence or Substance Related Disorder (excluding nicotine and caffeine) within the 12 months before screening, as defined by DSM 5 criteria.
• \-- Subject has Hamilton Anxiety Rating Scale (HAM A) total score ≥ 21 at screening and baseline.
• Subject has PSQI total score ≥ 8 at screening or baseline or moderate to severe insomnia as determined by the Investigator.
• Subject has a history of non-response (per clinician judgment) to two adequate treatment regimens of stimulant or non-stimulant treatment for ADHD.
• Subject has a history of epilepsy, seizures (except childhood febrile seizures), unexplained syncope or other unexplained blackouts (except single incident), or head trauma with loss of consciousness lasting more than 5 minutes, or a history of clinically significant multiple head traumas without loss of consciousness.
• Subject has an acute or chronic medical condition (other than ADHD) that in the opinion of the investigator could confound clinical assessments or interfere with the ability of the subject to participate in the study.
• Subject is currently taking or has taken within 6 weeks prior to screening an antidepressent medication; antipsychotic medication; or lithium (any lithium preparation or formulation).
• Subject is currently taking or has taken within the previous 6 months an anticonvulsant medication (eg, phenytoin, carbamazepine, lamotrigine, valproic acid); antipsychotic medication; or lithium (any lithium preparation or formulation).
• Subject is currently taking an alpha 2 adrenergic receptor agonist (including clonidine and guanfacine).
• Subject has a life-time history of a pattern of abuse or diversion of stimulants.
• Subject has a body mass index (BMI) less than 18 or greater than 35 kg/m2 at screening or baseline.
• Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at screening (in the past month). Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (59)

NoesisPharma,LLC

Phoenix, Arizona, 85032, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Southern California Research LLC

Beverly Hills, California, 90210, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

North County Clinical Research

Oceanside, California, 92056, United States

Location

University ot California, San Francisco

San Francisco, California, 94143, United States

Location

Elite Clinical Trials, Inc.

Wildomar, California, 92595, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

ConnecticutClinicalResearch

Cromwell, Connecticut, 06416, United States

Location

CNS Clinical Research Group

Coral Springs, Florida, 33067, United States

Location

Gulfcoast Clinical Research

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

The Institute for Advanced Medical Research

Alpharetta, Georgia, 30005, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Northwest Behavioral Research Center

Roswell, Georgia, 30076, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Capstone Clinical Research, Inc.

Libertyville, Illinois, 60048, United States

Location

Alpine Clinic

Lafayette, Indiana, 47905, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Saint Charles Psychiatric Associates/Midwest Research Group

Saint Charles, Missouri, 63301, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Village Clinical Research Inc.

New York, New York, 10003, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Eastside Comprehensive Medical Center, LLC

New York, New York, 10021, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Triangle Neuropsychiatry

Durham, North Carolina, 27707, United States

Location

University of Cincinnati, Department of Psychiatry

Cincinnati, Ohio, 45219, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Paradigm Research Professionals

Oklahoma City, Oklahoma, 73118, United States

Location

SummitResearchNetwork

Portland, Oregon, 97210, United States

Location

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, 97214, United States

Location

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, 97301, United States

Location

Keystone Clinical Studies, LLC

Norristown, Pennsylvania, 19403, United States

Location

Medical University of SC (MUSC)

Charleston, South Carolina, 29425, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

FutureSearch Clinical Trials, LP

Austin, Texas, 78731, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

Bayou City Research Corporation

Houston, Texas, 77007, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Road Runner Research

San Antonio, Texas, 78258, United States

Location

Family Psychiatry of the Woodlands

The Woodlands, Texas, 77381-4546, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

NeuroScience, Inc

Herndon, Virginia, 20170, United States

Location

Summit Research Network LLC

Seattle, Washington, 98104, United States

Location

Dean Foundation for Health, Research and Education

Middleton, Wisconsin, 53562, United States

Location

Related Publications (1)

• Adler LA, Goldman R, Hopkins SC, Koblan KS, Kent J, Hsu J, Loebel A. Dasotraline in adults with attention deficit hyperactivity disorder: a placebo-controlled, fixed-dose trial. Int Clin Psychopharmacol. 2021 May 1;36(3):117-125. doi: 10.1097/YIC.0000000000000333.

  PMID: 33724251 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine

Condition Hierarchy (Ancestors)

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

Study Officials

• SEP-289 Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 28, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

US (59)