NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
This study has been completed.
Sponsor:
New River Pharmaceuticals
Information provided by:
New River Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00557011
First received: November 9, 2007
Last updated: May 23, 2011
Last verified: May 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: NRP104 Drug: Adderall XR Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Treatment, 3-Period, Crossover Study With One Week Per Treatment and Once-a-Day Dosing of Either NRP104, Adderall XR, or Placebo in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD) |
Resource links provided by NLM:
Further study details as provided by New River Pharmaceuticals:
Primary Outcome Measures:
- SKAMP-DS scores across a treatment assessment day [ Time Frame: 1 week ]
Secondary Outcome Measures:
- SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day [ Time Frame: 1 week ]
- Treatment emergent adverse events [ Time Frame: 1 week ]
- PK profile and PK/PD relationship of NRP104 [ Time Frame: After multiple doses ]
| Enrollment: | 52 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2004 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
NRP104
|
Drug: NRP104
30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
Other Name: lisdexamfetamine dimesylate
|
|
Active Comparator: 2
Adderall XR
|
Drug: Adderall XR
10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
Other Name: mixed salts of a single-entity amphetamine
|
|
Placebo Comparator: 3
Placebo
|
Drug: Placebo
Placebo capsule taken once daily in the morning
|
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes
- on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects
Exclusion Criteria:
- co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder
- history of seizure during the last 2 years, a tic disorder or Tourette's
- clinically significant ECG or laboratory abnormalities at screening or baseline
- taking clonidine or anticonvulsant drugs
- taking medications that affect blood pressure or heart rate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557011
Sponsors and Collaborators
New River Pharmaceuticals
Investigators
| Principal Investigator: | Joseph Biederman, M.D. | Harvard Medical School |
| Principal Investigator: | Samuel Boellner, M.D. | Clinical Study Centers, LLC |
| Principal Investigator: | Ann Childress, M.D. | Center for Psychiatry and Behavioral Medicine, Inc. |
| Principal Investigator: | Frank Lopez, M.D. |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00557011 History of Changes |
| Other Study ID Numbers: | NRP104.201 |
| Study First Received: | November 9, 2007 |
| Last Updated: | May 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Adderall 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 May 23, 2013