An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT00337285

Last Updated: 2012-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-06-30

Brief Summary

The purpose of this study is to assess the long-term safety and efficacy of three NRP104 doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of adults with ADHD.

Detailed Description

This is a multi-center, open-label, and single-arm study to assess the safety of three NRP104 doses (30 mg, 50 mg, or 70 mg per day) for up to one (1) year in the treatment of adults with ADHD. Subjects who were randomized and met all inclusion/exclusion criteria in Protocol NRP104.303 are eligible for participation in this protocol. The study will consist of three periods: a screening/baseline period, a 4-week dose titration, and a long-term maintenance of up to 11 months. There are three possibilities for subjects that rollover from the NRP104.303 protocol. They are:

Subjects that rollover at the final visit of the NRP104.303 study (on the same day):

The screening and baseline procedures from this open label study will coincide with the final study visit of Protocol NRP104.303. Subject data from final study visit will be transferred and utilized for the open label study. On this same day, the subject will be consented for NRP104.304, inclusion/exclusion criteria will be assessed, the subject will be enrolled, and study medication will be dispensed.

Subjects that rollover not on the same day but within seven days of the NRP104.303 study:

If the subject returns to enroll into the NRP104.304 study within seven days of the final NRP104.303 study visit and has not taken any excluded medications for which a washout is required, the final study visit procedures and data from the NRP104.303 study will be transferred and utilized for the screening and baseline visit procedures of this study, where applicable. When the subject returns to the site, they will be consented, inclusion and exclusion criteria will be assessed, the subject will be enrolled, and study medication will be dispensed.

Subjects will require a full screening visit if more than 7 days have elapsed since they completed the NRP104.303 study:

After screening results have been received by the site, the site personnel will contact the subject via telephone to inform them of continued study eligibility. During this call the subject will be instructed to stop all medications for the treatment of ADHD, if any. This call starts the washout of all psychoactive medications, which should last 7 (±2) days. During the Washout Phone Contact, the visit dates for the Baseline visit (Visit 01) and Visits 02 through 05 should be scheduled at 7-day intervals as calculated from Baseline. After the washout is complete, subjects will return to the clinic for the baseline visit (Visit 01) to have the baseline procedures performed and to receive study medication.

Dose Titration

All subjects will initiate treatment at NRP104 30 mg for the 1st week. At the subsequent 4 weekly visits (Visits 02, 03, 04, and 05), the subject's daily dose of NRP104 may be increased or decreased by 20 mg at weekly intervals to achieve the optimal efficacy and tolerability, if deemed appropriate by the Investigator. In this study, the maximum daily dose of NRP104 that can be received by the subject is 70 mg, and the minimum daily dose of NRP104 the subject must take to continue the treatment is 30 mg.

Monthly Maintenance

At the end of the initial 4-week dose titration (Visit 05), subjects will enter the long-term maintenance of up to 11 months. Monthly visits, starting with Visit 06, will have a window of ±4 days. All visits will be scheduled relative to the Baseline Visit date. The last scheduled visit of the protocol is Visit 16 at Month 12. During the long-term maintenance, the subject's dose may be increased or decreased by 20 mg at any visit, if deemed appropriate by the Investigator, to maintain optimal treatment in terms of efficacy and tolerability. All reasons for dose changes should be well documented by the investigator during the maintenance period. Subjects who cannot maintain the minimum daily dose of NRP 30 mg due to intolerance will be withdrawn from the study.

Safety and Efficacy Assessments

ADHD Rating Scale (ADHD-RS) performed using adult prompts and Clinical Global Impression (CGI) will be assessed by the Investigator. The Pittsburgh Sleep Quality Index (PSQI) will be assessed once every three months following baseline.

Adverse events and concomitant medications will be recorded at each visit starting from the baseline visit. Vital signs will be measured at each visit from the screening visit. Physical exam and clinical laboratory tests (including pregnancy tests) will be assessed at Screening, Visit 10 and the final visit. Weight will be measured at the screening visit, baseline visit, and every month thereafter. Height will be measured at the screening visit and final visit. ECG parameters will be assessed at the screening visit, baseline visit, and every 3 months thereafter.

Conditions

Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders With Hyperactivity; Attention Deficit Hyperactivity Disorders

Keywords

Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders with Hyperactivity; Attention Deficit Hyperactivity Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Vyvanse (lisdexamfetamine dimesylate), NRP104

Intervention Type: DRUG

NRP104 capsule once-a-day orally beginning at 30mg/day and titrated by 20 mg per day at weekly intervals up to a maximum daily dose of 70 mg

Interventions

Vyvanse (lisdexamfetamine dimesylate), NRP104

NRP104 capsule once-a-day orally beginning at 30mg/day and titrated by 20 mg per day at weekly intervals up to a maximum daily dose of 70 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject must be 18-55 years of age, inclusive, at the time of consent of the NRP104.303 study.

Exclusion Criteria

• Subject must be male or non-pregnant female. Females of childbearing potential (FOCP) must comply with contraceptive restrictions noted in the protocol.
• Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, PE, clinical and laboratory evaluation.
• In the opinion of the investigator, the subject understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
• Subject must have given written, personally signed and dated 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 specific procedures.
• Subject experienced no adverse events in a previous study of NRP104 or elsewhere that would preclude continued exposure to NRP104.

• Subject 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 who have a history of mental retardation or a severe learning disability are excluded.
• Subject has a known cardiac structural abnormality or any other condition that may affect cardiac performance.
• Subject has any clinically significant ECG or laboratory abnormality known to the investigator prior to dispensation of study medication.
• Subject has a resting sitting systolic blood pressure or diastolic blood pressure deemed clinically significant by the investigator.
• Subject has used any prohibited prescription medication except for medications used to treat ADHD within 30 days of screening visit. Hormonal contraceptives are acceptable.
• Subject has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy, if any).
• Subject has taken an investigational drug or taken part in a clinical trial within 30 days prior to Screening (except for participating in an NRP104 study).
• The female subject is pregnant or lactating.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

New River Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Shire Pharmaceutical

Principal Investigators

Joseph Biederman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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

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

Masschusetts 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

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, United States

CNS Research Institute (CRI)

Clementon, New Jersey, United States

VA New York 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

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

United States

References

Ginsberg L, Katic A, Adeyi B, Dirks B, Babcock T, Lasser R, Scheckner B, Adler LA. Long-term treatment outcomes with lisdexamfetamine dimesylate for adults with attention-deficit/hyperactivity disorder stratified by baseline severity. Curr Med Res Opin. 2011 Jun;27(6):1097-107. doi: 10.1185/03007995.2011.567256. Epub 2011 Mar 28.

Reference Type: RESULT

PMID: 21438796 (View on PubMed)

Mattingly G, Weisler R, Dirks B, Babcock T, Adeyi B, Scheckner B, Lasser R. Attention deficit hyperactivity disorder subtypes and symptom response in adults treated with lisdexamfetamine dimesylate. Innov Clin Neurosci. 2012 May;9(5-6):22-30.

Reference Type: RESULT

PMID: 22808446 (View on PubMed)

Related Links

http://www.fda.gov/opacom/7alerts.html

(FDA Recall Information)

Other Identifiers

NRP104.304

Identifier Type: -

Identifier Source: org_study_id