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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00557011
Other study ID # NRP104.201
Secondary ID
Status Completed
Phase Phase 2
First received November 9, 2007
Last updated May 23, 2011
Start date September 2004
Est. completion date December 2004

Study information

Verified date May 2011
Source New River Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 12 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Intervention

Drug:
NRP104
30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
Adderall XR
10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
Placebo
Placebo capsule taken once daily in the morning

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
New River Pharmaceuticals

References & Publications (1)

Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 20 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary SKAMP-DS scores across a treatment assessment day 1 week
Secondary SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day 1 week
Secondary Treatment emergent adverse events 1 week
Secondary PK profile and PK/PD relationship of NRP104 After multiple doses
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Completed NCT00050050 - Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder Phase 1
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