Attention Deficit Hyperactivity DisorderPhase 3NCT00556296
Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD
A Phase 3 study testing NRP104 in people with Attention Deficit Hyperactivity Disorder, run by New River Pharmaceuticals.
Trial summary
This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- NRP104
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Sep 2005
- Phase
- Phase 3
- 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
- primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria
- functioning at age appropriate levels intellectually
- blood pressure measurements within the 95th percentile for their gender, height and age
- ECG results are within the normal range
Who cannot join
- comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations
- history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder
- weighs less than 55 lbs (25 kg)or is significantly overweight or obese
- clinically significant ECG abnormality
- documented allergy or intolerance to amphetamines
About this study
Official title: A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder
This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- NRP104, 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
NRP104 30mg capsule once daily in a.m.
NRP104Drug
NRP104 50mg capsule once daily in a.m.
NRp104Drug
NRP104 70mg capsule once daily in a.m.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: NRP104 |
| 2 | Experimental | Not described Receives: Drug: NRP104 |
| 3 | Experimental | Not described Receives: Drug: NRp104 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change score from baseline of the ADHD-RS
Measured: 4 weeks
Secondary outcomes (3)
Duration of therapeutic responses using the CPRS ADHD Index
Measured: At treatment endpoint, separately for morning, afternoon and evening responses
Clinical global impression of severity(CGI-S) and improvement (CGI-I)
Measured: Treatment endpoint
Treatment emergent AEs
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startOct 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- New River Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shire
- Investigators
- Suma Krishnan, Study director, New River Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556296
- Sponsor's protocol ID
- NRP104.301
- Status last verified
- Jun 2011
- First submitted
- 7 Nov 2007
- Last updated
- 21 Jun 2011
- Results posted
- No
Publications
Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007 Mar;29(3):450-63. doi: 10.1016/s0149-2918(07)80083-x.
PubMed 17577466Faraone SV, Spencer TJ, Kollins SH and Glatt SJ. Moderators of Dose-Response Effects of Lisdexamfetamine Dimesylate Treatment in Children With ADHD. Journal of ADHD and Related Disorders 1(3):16-24, 2010
Jain R, Babcock T, Burtea T, Dirks B, Adeyi B, Scheckner B, Lasser R. Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. Child Adolesc Psychiatry Ment Health. 2011 Nov 4;5(1):35. doi: 10.1186/1753-2000-5-35.
PubMed 22054243Waxmonsky JG, Waschbusch DA, Glatt SJ, Faraone SV. Prediction of placebo response in 2 clinical trials of lisdexamfetamine dimesylate for the treatment of ADHD. J Clin Psychiatry. 2011 Oct;72(10):1366-75. doi: 10.4088/JCP.10m05979pur.
PubMed 21367347Faraone 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 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00556296
- Acronym / sponsor ID
- NRP104.301
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- New River PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Shire
- Study start
- Oct 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 9 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.
This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NRP104 |
| 2 | Experimental | Drug: NRP104 |
| 3 | Experimental | Drug: NRp104 |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria
- functioning at age appropriate levels intellectually
- blood pressure measurements within the 95th percentile for their gender, height and age
- ECG results are within the normal range
Key exclusion criteria (5 listed)
- comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations
- history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder
- weighs less than 55 lbs (25 kg)or is significantly overweight or obese
- clinically significant ECG abnormality
- documented allergy or intolerance to amphetamines
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 |
|---|---|---|
| NRP104NRP104 30mg capsule once daily in a.m. | Drug | 1 |
| NRP104NRP104 50mg capsule once daily in a.m. | Drug | 2 |
| NRp104NRP104 70mg capsule once daily in a.m. | Drug | 3 |
| PlaceboPlacebo | Drug | 4 |
Primary outcome
Change score from baseline of the ADHD-RS
Time frame: 4 weeks
3 secondary outcomes
Duration of therapeutic responses using the CPRS ADHD Index
Time frame: At treatment endpoint, separately for morning, afternoon and evening responses
Clinical global impression of severity(CGI-S) and improvement (CGI-I)
Time frame: Treatment endpoint
Treatment emergent AEs
Time frame: 4 weeks
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 21 Jun 2011.
- Results publication: PubMed 17577466Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007 Mar;29(3):450-63. doi: 10.1016/s0149-2918(07)80083-x.
- Results publicationFaraone SV, Spencer TJ, Kollins SH and Glatt SJ. Moderators of Dose-Response Effects of Lisdexamfetamine Dimesylate Treatment in Children With ADHD. Journal of ADHD and Related Disorders 1(3):16-24, 2010
- Derived from this study: PubMed 22054243Jain R, Babcock T, Burtea T, Dirks B, Adeyi B, Scheckner B, Lasser R. Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. Child Adolesc Psychiatry Ment Health. 2011 Nov 4;5(1):35. doi: 10.1186/1753-2000-5-35.
- Derived from this study: PubMed 21367347Waxmonsky JG, Waschbusch DA, Glatt SJ, Faraone SV. Prediction of placebo response in 2 clinical trials of lisdexamfetamine dimesylate for the treatment of ADHD. J Clin Psychiatry. 2011 Oct;72(10):1366-75. doi: 10.4088/JCP.10m05979pur.
- 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.
Suma Krishnan study director
New River Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NRP104 in people with Attention Deficit Hyperactivity Disorder, 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 4 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 21 Jun 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change score from baseline of the ADHD-RS (time frame: 4 weeks). 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 NCT00556296, which also lists 5 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 21 Jun 2011.