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

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by:
New River Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00337285
First received: June 9, 2006
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders With Hyperactivity
Attention Deficit Hyperactivity Disorders
Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, and Single-Arm Study of NRP104 30 mg, 50 mg, or 70 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by New River Pharmaceuticals:

Primary Outcome Measures:
  • Change in ADHD-RS-IV Total Score From Baseline at Up to One Year [ Time Frame: up to one year ] [ Designated as safety issue: No ]
    Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.


Secondary Outcome Measures:
  • Number of Participants With Improvement on CGI-I [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.

  • Change in PSQI Total Score From Baseline at Up to One Year [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
    Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.


Enrollment: 349
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be 18-55 years of age, inclusive, at the time of consent of the NRP104.303 study.
  • Subject must have been randomized and must have met all inclusion/exclusion criteria in the NRP104.303 study.
  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337285

  Show 45 Study Locations
Sponsors and Collaborators
New River Pharmaceuticals
Shire
Investigators
Principal Investigator: Joseph Biederman, M.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00337285     History of Changes
Other Study ID Numbers: NRP104.304
Study First Received: June 9, 2006
Results First Received: May 28, 2009
Last Updated: August 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New River Pharmaceuticals:
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders with Hyperactivity
Attention Deficit Hyperactivity Disorders

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Nervous System Diseases
Hyperkinesis
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014