Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
NCT ID: NCT00334880
Last Updated: 2009-07-02
Study Results
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Basic Information
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COMPLETED
PHASE3
420 participants
INTERVENTIONAL
2006-05-31
2006-11-30
Brief Summary
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Detailed Description
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The study will have three phases: (1) screening and washout; (2) baseline; and (3) 4-week double-blind evaluation of NRP104 and placebo. The double-blind period will include a forced dose titration phase followed by a fixed dose phase. Subjects will be required to visit the site up to 6 times over a 5-8 week period, or longer in cases requiring a 28-day wash out.
Screening and Washout: Subjects will be screened to establish eligibility for study participation. The Screening Visit (Visit 1) may take place over multiple days if needed to accommodate the subject's schedule. Those subjects who meet eligibility requirements will undergo medication washout, if applicable. The length of the ADHD medication washout period will range from 7-28 days.
Baseline: Following medication washout, subjects will return to the clinic for reassessment of eligibility criteria and establishment of baseline measures. The interval between the first day of the Screening Visit (informed consent date) and the Baseline Visit (Visit 2) must not exceed 35 days. Eligible subjects with a baseline ADHD-RS score greater than or equal to 28 (performed using adult DSM-IV prompts) will be randomized to treatment.
Double-blind treatment: Eligible subjects will be randomly assigned (in a 2:2:2:1 ratio of each of the three active doses vs. placebo) to a daily morning dose of NRP104 or placebo for 4 weeks. All NRP104 groups will start at a dose of 30 mg/day. Subjects randomized to 70 mg will be titrated to that dose over a 2-week period; those randomized to 50 mg will be titrated to that dose over a 1-week period; and those randomized to 30 mg will begin dosing on 30 mg per day during week one and will remain on that dose throughout the study. Double-blind assessment of the safety and efficacy of NRP104 will proceed for 4 weeks with weekly clinic visits scheduled for evaluations and medication disbursement.
Follow-up period: Subjects who have completed at least 2 weeks of double-blind participation, will have the option to continue participation in an open-label extension study (Protocol NRP104.304: one-year safety study). Subjects who are not eligible or who choose not to participate in the extension study will continue to be followed for thirty days following their last dose of study drug. A telephone contact (or contact in person) will be initiated by the research site to collect any new or ongoing SAEs and to follow-up on any unresolved or related AEs from the Final Study Visit or Early Termination (ET) Visit (Visit 6). If the Principal Investigator determines AEs are not acceptably resolved, appropriate follow-up should continue until all safety concerns, in the opinion of the Investigator, are resolved.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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NRP104
Eligibility Criteria
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Inclusion Criteria
* 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:
1. QT/QTcF interval \< 450 msec for males and \< 470 msec for females
2. Resting heart rate is between 40 and 100 beats per minute
3. P-R interval \< 200 msec
4. QRS interval \<110 msec.
* Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM-IV-TR™) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a psychiatric evaluation that reviews DSM-IV-TR™ 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.
Exclusion Criteria
* 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-TR™ 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-TR™ 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.
18 Years
55 Years
ALL
No
Sponsors
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New River Pharmaceuticals
INDUSTRY
Principal Investigators
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Joseph Biederman, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Valley Clinical Research, Inc.
El Centro, California, United States
University of California, Irvine Child Development Center
Irvine, California, United States
Bay Area Research Institute
Lafayette, California, United States
Peninsula Research Associates
Rolling Hills Estate, California, United States
University of California, San Francisco, Dept. of Psychiatry
San Francisco, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Psychiatric Medicine Center
New London, Connecticut, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Miami Research Associates
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Meridien Research
Tampa, Florida, United States
Janus Center for Psychiatric Research LLC
West Palm Beach, Florida, United States
Northwest Behavioral Research Center
Roswell, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Psychiatric Associates
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Johns Hopkins at Green Spring Station
Lutherville, Maryland, United States
Marc Hertzman, MD
Rockville, Maryland, United States
Massachusetts General Hospital
Cambridge, Massachusetts, United States
Summit Research Network (Michigan) Inc.
Flint, Michigan, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
St Charles Psychiatric Associates-Midwest Research
Saint Charles, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States
CNS Research Institute (CRI)
Clementon, New Jersey, United States
VA NY Harbor Healthcare System
New York, New York, United States
Duke University ADHD Program
Durham, North Carolina, United States
Richard Weisler and Associates
Raleigh, North Carolina, United States
University Hospitals of Cleveland, Case Western Reserve University
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States
CNS Research Institute, P.C.
Philadelphia, Pennsylvania, United States
FutureSearch Trials
Austin, Texas, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States
Bayou City Research
Houston, Texas, United States
Red Oak Psychiatry Associates, P.A.
Houston, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
John M. Turnbow, MD, PA
Lubbock, Texas, United States
The Clinical Study Center
Burlington, Vermont, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
Psychiatric Alliance of the Blue Ridge Clinical Research
Charlottesville, Virginia, United States
NeuroScience, Inc.
Herndon, Virginia, United States
Brighton Research Group
Virginia Beach, Virginia, United States
Summit Research Network LLC (Seattle)
Seattle, Washington, United States
Countries
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References
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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.
Schein 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.
Mattingly 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.
Babcock 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.
Surman 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.
Waxmonsky 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.
Adler 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.
Adler 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.
Related Links
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FDA recall information
Other Identifiers
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NRP104.303
Identifier Type: -
Identifier Source: org_study_id
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