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Attention Deficit Hyperactivity DisorderPhase 3NCT00334880

Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

A Phase 3 study testing NRP104 in people with Attention Deficit Hyperactivity Disorder and Attention Deficit Disorders With Hyperactivity, run by New River Pharmaceuticals at 48 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
NRP104
How many people
420 participants
Where
48 sitesUnited States
Study dates
May 2006to Nov 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • P-R interval < 200 msec
  • 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.

Who cannot join

  • 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-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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • FutureSearch Trials

    Austin, Texas, 78756

  • Claghorn-Lesem Research Clinic

    Bellaire, Texas, 77401

  • Alpine Clinical Research Center

    Boulder, Colorado, 80304

  • The Clinical Study Center

    Burlington, Vermont, 05401

  • Massachusetts General Hospital

    Cambridge, Massachusetts, 02138

  • Psychiatric Alliance of the Blue Ridge Clinical Research

    Charlottesville, Virginia, 22903

  • CNS Research Institute (CRI)

    Clementon, New Jersey, 08021

  • University Hospitals of Cleveland, Case Western Reserve University

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • Duke University ADHD Program

    Durham, North Carolina, 27705

  • Valley Clinical Research, Inc.

    El Centro, California, 92243

  • Summit Research Network (Michigan) Inc.

    Flint, Michigan, 48507

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • NeuroScience, Inc.

    Herndon, Virginia, 20170

  • Bayou City Research

    Houston, Texas, 77007

  • Red Oak Psychiatry Associates, P.A.

    Houston, Texas, 77090

  • University of California, Irvine Child Development Center

    Irvine, California, 92612

  • Bay Area Research Institute

    Lafayette, California, 94549

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas, 77566

  • Center for Psychiatry and Behavioral Medicine

    Las Vegas, Nevada, 89128

  • Clinical Study Centers, LLC

    Little Rock, Arkansas, 72205

  • John M. Turnbow, MD, PA

    Lubbock, Texas, 79423

  • Johns Hopkins at Green Spring Station

    Lutherville, Maryland, 21093

  • Miami Research Associates

    Miami, Florida, 33173

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

  • Psychiatric Medicine Center

    New London, Connecticut, 06320

  • VA NY Harbor Healthcare System

    New York, New York, 10010

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Psychiatric Associates

    Overland Park, Kansas, 66211

  • Vince and Associates Clinical Research

    Overland Park, Kansas, 66212

  • CNS Research Institute, P.C.

    Philadelphia, Pennsylvania, 19149

  • Oregon Center for Clinical Investigations, Inc.

    Portland, Oregon, 97210-2659

  • Richard Weisler and Associates

    Raleigh, North Carolina, 27609

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • Marc Hertzman, MD

    Rockville, Maryland, 20852

  • Peninsula Research Associates

    Rolling Hills Estate, California, 90274

  • Northwest Behavioral Research Center

    Roswell, Georgia, 30076

  • St Charles Psychiatric Associates-Midwest Research

    Saint Charles, Missouri, 63301

  • University of California, San Francisco, Dept. of Psychiatry

    San Francisco, California, 94143

  • Summit Research Network LLC (Seattle)

    Seattle, Washington, 98104

  • Carman Research

    Smyrna, Georgia, 30080

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Meridien Research

    Tampa, Florida, 33606

  • Brighton Research Group

    Virginia Beach, Virginia, 23452

  • Janus Center for Psychiatric Research LLC

    West Palm Beach, Florida, 33407

  • Neuropsychiatric Associates

    Woodstock, Vermont, 05091

Other trials in United States

About this study

Official title: 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)

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).

Read the detailed description

This study is a randomized, phase III, multi-center, placebo-controlled, parallel-group, forced dose titration in which adult subjects (18-55 years of age inclusive) with ADHD will be randomized to NRP104 (30, 50, or 70 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy.

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.

Being tested
NRP104
Keywords
Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders with Hyperactivity, Attention Deficit Hyperactivity Disorders
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRP104Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts

    Measured: weekly over a period of 4 weeks

Secondary outcomes (3)

  1. The Clinical Global Impression of Improvement (CGI-I)

    Measured: 4 times over a period of 4 weeks

  2. Self-report of the Pittsburgh Sleep Quality Index (PSQI) measured at Baseline and at the Final Study Visit

    Measured: twice over a period of 4 weeks

  3. Occurrence of treatment-emergent adverse events and specific evaluation of blood pressure, heart rate, electrocardiogram (ECG), laboratory findings, and physical examination (PE)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334880
Sponsor's protocol ID
NRP104.303
Status last verified
Jul 2009
First submitted
7 Jun 2006
Last updated
2 Jul 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19012818

  • 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.

    PubMed 38824626

  • 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.

    PubMed 23356790

  • 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.

    PubMed 23254273

  • 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.

    PubMed 21824454

  • 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.

    PubMed 21367347

  • 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.

    PubMed 20141706

  • 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.

    PubMed 19650932

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NRP104 in people with Attention Deficit Hyperactivity Disorder and Attention Deficit Disorders With Hyperactivity, run by New River Pharmaceuticals at 48 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts (time frame: weekly over a period of 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334880, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2009.

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