Attention Deficit Disorder With HyperactivityPhase 2NCT00557011
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
A Phase 2 study testing NRP104 and Adderall XR in people with Attention Deficit Disorder With Hyperactivity, run by New River Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- NRP104 and Adderall XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Dec 2004
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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)
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.
- Being tested
- NRP104, Adderall XR, Placebo
- 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
Also called lisdexamfetamine dimesylate
30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
Adderall XRDrug
Also called mixed salts of a single-entity amphetamine
10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
PlaceboDrug
Placebo capsule taken once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NRP104 Receives: Drug: NRP104 |
| 2 | Active comparator | Adderall XR Receives: Drug: Adderall XR |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SKAMP-DS scores across a treatment assessment day
Measured: 1 week
Secondary outcomes (3)
SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day
Measured: 1 week
Treatment emergent adverse events
Measured: 1 week
PK profile and PK/PD relationship of NRP104
Measured: After multiple doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startSep 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- New River Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joseph Biederman, M.D., Principal investigator, Harvard Medical School (HMS and HSDM)Samuel Boellner, M.D., Principal investigator, Clinical Study Centers, LLCAnn Childress, M.D., Principal investigator, Center for Psychiatry And Behavioral Medicine Inc.Frank Lopez, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557011
- Sponsor's protocol ID
- NRP104.201
- Status last verified
- May 2011
- First submitted
- 9 Nov 2007
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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. 2007 Nov 1;62(9):970-6. doi: 10.1016/j.biopsych.2007.04.015. Epub 2007 Jul 12.
PubMed 17631866Faraone SV, Spencer TJ, Kollins SH, Glatt SJ. Effects of lisdexamfetamine dimesylate treatment for ADHD on growth. J Am Acad Child Adolesc Psychiatry. 2010 Jan;49(1):24-32. doi: 10.1097/00004583-201001000-00006.
PubMed 20215923
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00557011
- Acronym / sponsor ID
- NRP104.201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- New River PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NRP104NRP104 |
| 2 | Active comparator | Drug: Adderall XRAdderall XR |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRP104Also: lisdexamfetamine dimesylate30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning | Drug | 1 |
| Adderall XRAlso: mixed salts of a single-entity amphetamine10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg | Drug | 2 |
| PlaceboPlacebo capsule taken once daily in the morning | Drug | 3 |
Primary outcome
SKAMP-DS scores across a treatment assessment day
Time frame: 1 week
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
- Results publication: PubMed 17631866Biederman 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. 2007 Nov 1;62(9):970-6. doi: 10.1016/j.biopsych.2007.04.015. Epub 2007 Jul 12.
- Derived from this study: PubMed 20215923Faraone SV, Spencer TJ, Kollins SH, Glatt SJ. Effects of lisdexamfetamine dimesylate treatment for ADHD on growth. J Am Acad Child Adolesc Psychiatry. 2010 Jan;49(1):24-32. doi: 10.1097/00004583-201001000-00006.
- FDA Recall informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Biederman, M.D. principal investigator
Harvard Medical School (HMS and HSDM)
Samuel Boellner, M.D. principal investigator
Clinical Study Centers, LLC
Ann Childress, M.D. principal investigator
Center for Psychiatry And Behavioral Medicine Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRP104 and Adderall XR in people with Attention Deficit Disorder With Hyperactivity, run by New River Pharmaceuticals.
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 2 inclusion and 5 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 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
SKAMP-DS scores across a treatment assessment day (time frame: 1 week). 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 NCT00557011, which also lists 2 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 25 May 2011.