Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Forced Dose Titration, Safety and Efficacy Study of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
1 other identifier
interventional
420
1 country
48
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of NRP104 administered as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder (ADHD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2006
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 7, 2006
CompletedFirst Posted
Study publicly available on registry
June 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJuly 2, 2009
July 1, 2009
June 7, 2006
July 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts
weekly over a period of 4 weeks
Secondary Outcomes (3)
The Clinical Global Impression of Improvement (CGI-I)
4 times over a period of 4 weeks
Self-report of the Pittsburgh Sleep Quality Index (PSQI) measured at Baseline and at the Final Study Visit
twice over a period of 4 weeks
Occurrence of treatment-emergent adverse events and specific evaluation of blood pressure, heart rate, electrocardiogram (ECG), laboratory findings, and physical examination (PE)
4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Must be 18-55 years of age, inclusive.
- Must be male or non-pregnant female. Females of childbearing potential (FOCP) must use contraception.
- Must have a medical assessment with no clinically significant or relevant abnormalities as determined by medical history, PE, clinical and lab evaluation.
- Must have 12-lead ECGs defined by the following parameters:
- QT/QTcF interval \< 450 msec for males and \< 470 msec for females
- Resting heart rate is between 40 and 100 beats per minute
- P-R interval \< 200 msec
- QRS interval \<110 msec.
- Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM-IV-TRâ„¢) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a psychiatric evaluation that reviews DSM-IV-TRâ„¢ criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale (ACDS v1.2) will be utilized as the diagnostic tool.
- Has a baseline ADHD-RS score greater than or equal to 28 assessed using adult DSM-IV prompts.
- Understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
- Has given written informed consent to participate in the study in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and applicable regulations before completing any study procedures.
You may not qualify if:
- In the opinion of the investigator, the subject is significantly underweight \[e.g., Body Mass Index (BMI) \< 18.5\] or morbidly obese.
- Has any comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders including Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that will contraindicate NRP104 treatment or confound efficacy or safety assessments. Specifically, subjects with mild to moderate forms of Axis I disorders including social phobia and dysthymia may be included while subjects with a lifetime history of psychosis or bipolar disorder will be excluded from participation. Comorbid psychiatric diagnoses will be established by a psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TRâ„¢ disorders (SCID-I) interview at the screening visit.
- Has any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. Subjects with mental retardation or a severe learning disability are excluded.
- Has a history of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
- Has a known cardiac structural abnormality or any other condition that may affect cardiac performance.
- Has any clinically significant ECG or laboratory abnormality at Screening or Baseline.
- Subject has a history of hypertension or has a resting sitting systolic blood pressure \> 139mmHg or diastolic blood pressure \> 89mmHg.
- Has used any prohibited medication except for ADHD medications within 30 days of screening visit. Hormonal contraceptives are acceptable.
- Has a documented allergy, intolerance, or documented history of non-responsivity to methylphenidate or amphetamine.
- Currently has (or had a history within the last 6 months of) a drug dependence or substance abuse disorder according to DSM-IV-TRâ„¢ criteria (excluding nicotine) as established by a SCID-I at the screening visit.
- Has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy, if any) or at Baseline.
- Has taken an investigational drug or taken part in a clinical trial within 30 days prior to Screening.
- The female subject is pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
Valley Clinical Research, Inc.
El Centro, California, 92243, United States
University of California, Irvine Child Development Center
Irvine, California, 92612, United States
Bay Area Research Institute
Lafayette, California, 94549, United States
Peninsula Research Associates
Rolling Hills Estate, California, 90274, United States
University of California, San Francisco, Dept. of Psychiatry
San Francisco, California, 94143, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Alpine Clinical Research Center
Boulder, Colorado, 80304, United States
Yale University School of Medicine
New Haven, Connecticut, 06511, United States
Psychiatric Medicine Center
New London, Connecticut, 06320, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Miami Research Associates
Miami, Florida, 33173, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Meridien Research
Tampa, Florida, 33606, United States
Janus Center for Psychiatric Research LLC
West Palm Beach, Florida, 33407, United States
Northwest Behavioral Research Center
Roswell, Georgia, 30076, United States
Carman Research
Smyrna, Georgia, 30080, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Johns Hopkins at Green Spring Station
Lutherville, Maryland, 21093, United States
Marc Hertzman, MD
Rockville, Maryland, 20852, United States
Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
Summit Research Network (Michigan) Inc.
Flint, Michigan, 48507, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
St Charles Psychiatric Associates-Midwest Research
Saint Charles, Missouri, 63301, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128, United States
CNS Research Institute (CRI)
Clementon, New Jersey, 08021, United States
VA NY Harbor Healthcare System
New York, New York, 10010, United States
Duke University ADHD Program
Durham, North Carolina, 27705, United States
Richard Weisler and Associates
Raleigh, North Carolina, 27609, United States
University Hospitals of Cleveland, Case Western Reserve University
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210-2659, United States
CNS Research Institute, P.C.
Philadelphia, Pennsylvania, 19149, United States
FutureSearch Trials
Austin, Texas, 78756, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
Bayou City Research
Houston, Texas, 77007, United States
Red Oak Psychiatry Associates, P.A.
Houston, Texas, 77090, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
John M. Turnbow, MD, PA
Lubbock, Texas, 79423, United States
The Clinical Study Center
Burlington, Vermont, 05401, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
Psychiatric Alliance of the Blue Ridge Clinical Research
Charlottesville, Virginia, 22903, United States
NeuroScience, Inc.
Herndon, Virginia, 20170, United States
Brighton Research Group
Virginia Beach, Virginia, 23452, United States
Summit Research Network LLC (Seattle)
Seattle, Washington, 98104, United States
Related Publications (8)
Adler LA, Goodman DW, Kollins SH, Weisler RH, Krishnan S, Zhang Y, Biederman J; 303 Study Group. Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008 Sep;69(9):1364-73. doi: 10.4088/jcp.v69n0903. Epub 2008 Sep 9.
PMID: 19012818RESULTSchein J, Cloutier M, Gauthier-Loiselle M, Catillon M, Xu C, Chan D, Childress A. Assessment of centanafadine in adults with attention-deficit/hyperactivity disorder: A matching-adjusted indirect comparison vs lisdexamfetamine dimesylate, atomoxetine hydrochloride, and viloxazine extended-release. J Manag Care Spec Pharm. 2024 Jun;30(6):528-540. doi: 10.18553/jmcp.2024.30.6.528.
PMID: 38824626DERIVEDMattingly GW, Weisler RH, Young J, Adeyi B, Dirks B, Babcock T, Lasser R, Scheckner B, Goodman DW. Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. BMC Psychiatry. 2013 Jan 29;13:39. doi: 10.1186/1471-244X-13-39.
PMID: 23356790DERIVEDBabcock T, Dirks B, Adeyi B, Scheckner B. Efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder previously treated with amphetamines: analyses from a randomized, double-blind, multicenter, placebo-controlled titration study. BMC Pharmacol Toxicol. 2012 Dec 19;13:18. doi: 10.1186/2050-6511-13-18.
PMID: 23254273DERIVEDSurman CB, Roth T. Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials. J Clin Psychiatry. 2011 Jul;72(7):903-8. doi: 10.4088/JCP.11m06838.
PMID: 21824454DERIVEDWaxmonsky JG, Waschbusch DA, Glatt SJ, Faraone SV. Prediction of placebo response in 2 clinical trials of lisdexamfetamine dimesylate for the treatment of ADHD. J Clin Psychiatry. 2011 Oct;72(10):1366-75. doi: 10.4088/JCP.10m05979pur.
PMID: 21367347DERIVEDAdler LA, Weisler RH, Goodman DW, Hamdani M, Niebler GE. Short-term effects of lisdexamfetamine dimesylate on cardiovascular parameters in a 4-week clinical trial in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2009 Dec;70(12):1652-61. doi: 10.4088/JCP.09m05335pur.
PMID: 20141706DERIVEDAdler LA, Goodman D, Weisler R, Hamdani M, Roth T. Effect of lisdexamfetamine dimesylate on sleep in adults with attention-deficit/hyperactivity disorder. Behav Brain Funct. 2009 Aug 3;5:34. doi: 10.1186/1744-9081-5-34.
PMID: 19650932DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Biederman, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 7, 2006
First Posted
June 8, 2006
Study Start
May 1, 2006
Study Completion
November 1, 2006
Last Updated
July 2, 2009
Record last verified: 2009-07