Attention Deficit Hyperactivity DisorderPhase 3NCT00337285
An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study testing Vyvanse (lisdexamfetamine dimesylate), NRP104 in people with Attention Deficit Hyperactivity Disorder and Attention Deficit Disorders With Hyperactivity, run by New River Pharmaceuticals at 45 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders
- What is being tested?
- Vyvanse (lisdexamfetamine dimesylate), NRP104
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 45 sitesUnited States
- Study dates
- Jul 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
FutureSearch Trials
Austin, Texas, 78756
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401
Alpine Clinical Research Center
Boulder, Colorado, 80304
The Clinical Study Center
Burlington, Vermont, 05401
Masschusetts General Hospital
Cambridge, Massachusetts, 02138
Psychiatric Alliance of the Blue Ridge Clinical Research
Charlottesville, Virginia, 22903
CNS Research Institute (CRI)
Clementon, New Jersey, 08021
The Ohio State University
Columbus, Ohio, 43210
Duke University ADHD Program
Durham, North Carolina, 27705
Valley Clinical Research, Inc.
El Centro, California, 92243
Summit Research Network (Michigan) Inc.
Flint, Michigan, 48507
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
NeuroScience, Inc.
Herndon, Virginia, 20170
Bayou City Research
Houston, Texas, 77007
Red Oak Psychiatry Associates, P.A.
Houston, Texas, 77090
University of California, Irvine Child Development Center
Irvine, California, 92612
Bay Area Research Institute
Lafayette, California, 94549
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
John M. Turnbow, MD, PA
Lubbock, Texas, 79423
Johns Hopkins at Green Spring Station
Lutherville, Maryland, 21093
Miami Research Associates
Miami, Florida, 33173
Psychiatric Medicine Center
New London, Connecticut, 06320
VA New York Harbor Healthcare System
New York, New York, 10010
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Psychiatric Associates
Overland Park, Kansas, 66211
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
CNS Research Institute, P.C.
Philadelphia, Pennsylvania, 19149
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210-2659
Richard Weisler and Associates
Raleigh, North Carolina, 27609
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Marc Hertzman, MD
Rockville, Maryland, 20852
Peninsula Research Associates
Rolling Hills Estate, California, 90274
Northwest Behavioral Research Center
Roswell, Georgia, 30076
St Charles Psychiatric Associates-Midwest Research
Saint Charles, Missouri, 63301
University of California, San Francisco, Dept. of Psychiatry
San Francisco, California, 94143
Summit Research Network LLC (Seattle)
Seattle, Washington, 98104
Carman Research
Smyrna, Georgia, 30080
Encompass Clinical Research
Spring Valley, California, 91978
Meridien Research
Tampa, Florida, 33606
Brighton Research Group
Virginia Beach, Virginia, 23452
Janus Center for Psychiatric Research LLC
West Palm Beach, Florida, 33407
Neuropsychiatric Associates
Woodstock, Vermont, 05091
About this study
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)
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.
Read the detailed description
This is a multi-center, open-label, and single-arm study to assess the safety of three NRP104 doses (30 mg, 50 mg, or 70 mg per day) for up to one (1) year in the treatment of adults with ADHD. Subjects who were randomized and met all inclusion/exclusion criteria in Protocol NRP104.303 are eligible for participation in this protocol. The study will consist of three periods: a screening/baseline period, a 4-week dose titration, and a long-term maintenance of up to 11 months. There are three possibilities for subjects that rollover from the NRP104.303 protocol. They are:
Subjects that rollover at the final visit of the NRP104.303 study (on the same day):
The screening and baseline procedures from this open label study will coincide with the final study visit of Protocol NRP104.303. Subject data from final study visit will be transferred and utilized for the open label study. On this same day, the subject will be consented for NRP104.304, inclusion/exclusion criteria will be assessed, the subject will be enrolled, and study medication will be dispensed.
Subjects that rollover not on the same day but within seven days of the NRP104.303 study:
If the subject returns to enroll into the NRP104.304 study within seven days of the final NRP104.303 study visit and has not taken any excluded medications for which a washout is required, the final study visit procedures and data from the NRP104.303 study will be transferred and utilized for the screening and baseline visit procedures of this study, where applicable. When the subject returns to the site, they will be consented, inclusion and exclusion criteria will be assessed, the subject will be enrolled, and study medication will be dispensed.
Subjects will require a full screening visit if more than 7 days have elapsed since they completed the NRP104.303 study:
After screening results have been received by the site, the site personnel will contact the subject via telephone to inform them of continued study eligibility. During this call the subject will be instructed to stop all medications for the treatment of ADHD, if any. This call starts the washout of all psychoactive medications, which should last 7 (±2) days. During the Washout Phone Contact, the visit dates for the Baseline visit (Visit 01) and Visits 02 through 05 should be scheduled at 7-day intervals as calculated from Baseline. After the washout is complete, subjects will return to the clinic for the baseline visit (Visit 01) to have the baseline procedures performed and to receive study medication.
Dose Titration
All subjects will initiate treatment at NRP104 30 mg for the 1st week. At the subsequent 4 weekly visits (Visits 02, 03, 04, and 05), the subject's daily dose of NRP104 may be increased or decreased by 20 mg at weekly intervals to achieve the optimal efficacy and tolerability, if deemed appropriate by the Investigator. In this study, the maximum daily dose of NRP104 that can be received by the subject is 70 mg, and the minimum daily dose of NRP104 the subject must take to continue the treatment is 30 mg.
Monthly Maintenance
At the end of the initial 4-week dose titration (Visit 05), subjects will enter the long-term maintenance of up to 11 months. Monthly visits, starting with Visit 06, will have a window of ±4 days. All visits will be scheduled relative to the Baseline Visit date. The last scheduled visit of the protocol is Visit 16 at Month 12. During the long-term maintenance, the subject's dose may be increased or decreased by 20 mg at any visit, if deemed appropriate by the Investigator, to maintain optimal treatment in terms of efficacy and tolerability. All reasons for dose changes should be well documented by the investigator during the maintenance period. Subjects who cannot maintain the minimum daily dose of NRP 30 mg due to intolerance will be withdrawn from the study.
Safety and Efficacy Assessments
ADHD Rating Scale (ADHD-RS) performed using adult prompts and Clinical Global Impression (CGI) will be assessed by the Investigator. The Pittsburgh Sleep Quality Index (PSQI) will be assessed once every three months following baseline.
Adverse events and concomitant medications will be recorded at each visit starting from the baseline visit. Vital signs will be measured at each visit from the screening visit. Physical exam and clinical laboratory tests (including pregnancy tests) will be assessed at Screening, Visit 10 and the final visit. Weight will be measured at the screening visit, baseline visit, and every month thereafter. Height will be measured at the screening visit and final visit. ECG parameters will be assessed at the screening visit, baseline visit, and every 3 months thereafter.
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders
- Being tested
- Vyvanse (lisdexamfetamine dimesylate), NRP104
- Keywords
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders with Hyperactivity, Attention Deficit Hyperactivity Disorders
- 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.
Vyvanse (lisdexamfetamine dimesylate), NRP104Drug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD-RS-IV Total Score From Baseline at Up to One Year
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.
Measured: up to one year
Secondary outcomes (2)
Number of Participants With Improvement on CGI-I
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.
Measured: Up to 1 year
Change in PSQI Total Score From Baseline at Up to One Year
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionNov 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- New River Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shire
- Investigators
- Joseph Biederman, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337285
- Sponsor's protocol ID
- NRP104.304
- Status last verified
- Aug 2012
- First submitted
- 9 Jun 2006
- Last updated
- 20 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ginsberg L, Katic A, Adeyi B, Dirks B, Babcock T, Lasser R, Scheckner B, Adler LA. Long-term treatment outcomes with lisdexamfetamine dimesylate for adults with attention-deficit/hyperactivity disorder stratified by baseline severity. Curr Med Res Opin. 2011 Jun;27(6):1097-107. doi: 10.1185/03007995.2011.567256. Epub 2011 Mar 28.
PubMed 21438796Mattingly G, Weisler R, Dirks B, Babcock T, Adeyi B, Scheckner B, Lasser R. Attention deficit hyperactivity disorder subtypes and symptom response in adults treated with lisdexamfetamine dimesylate. Innov Clin Neurosci. 2012 May;9(5-6):22-30.
PubMed 22808446
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00337285
- Acronym / sponsor ID
- NRP104.304
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders
- Keywords
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders with Hyperactivity, Attention Deficit Hyperactivity Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- New River PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Shire
- Study start
- Jul 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Jun 2006 (estimated)
- Results
- Posted 17 Jul 2009
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 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.
Detailed description
This is a multi-center, open-label, and single-arm study to assess the safety of three NRP104 doses (30 mg, 50 mg, or 70 mg per day) for up to one (1) year in the treatment of adults with ADHD. Subjects who were randomized and met all inclusion/exclusion criteria in Protocol NRP104.303 are eligible for participation in this protocol. The study will consist of three periods: a screening/baseline period, a 4-week dose titration, and a long-term maintenance of up to 11 months. There are three possibilities for subjects that rollover from the NRP104.303 protocol. They are:
Subjects that rollover at the final visit of the NRP104.303 study (on the same day):
The screening and baseline procedures from this open label study will coincide with the final study visit of Protocol NRP104.303. Subject data from final study visit will be transferred and utilized for the open label study. On this same day, the subject will be consented for NRP104.304, inclusion/exclusion criteria will be assessed, the subject will be enrolled, and study medication will be dispensed.
Subjects that rollover not on the same day but within seven days of the NRP104.303 study:
If the subject returns to enroll into the NRP104.304 study within seven days of the final NRP104.303 study visit and has not taken any excluded medications for which a washout is required, the final study visit procedures and data from the NRP104.303 study will be transferred and utilized for the screening and baseline visit procedures of this study, where applicable. When the subject returns to the site, they will be consented, inclusion and exclusion criteria will be assessed, the subject will be enrolled, and study medication will be dispensed.
Subjects will require a full screening visit if more than 7 days have elapsed since they completed the NRP104.303 study:
After screening results have been received by the site, the site personnel will contact the subject via telephone to inform them of continued study eligibility. During this call the subject will be instructed to stop all medications for the treatment of ADHD, if any. This call starts the washout of all psychoactive medications, which should last 7 (±2) days. During the Washout Phone Contact, the visit dates for the Baseline visit (Visit 01) and Visits 02 through 05 should be scheduled at 7-day intervals as calculated from Baseline. After the washout is complete, subjects will return to the clinic for the baseline visit (Visit 01) to have the baseline procedures performed and to receive study medication.
Dose Titration
All subjects will initiate treatment at NRP104 30 mg for the 1st week. At the subsequent 4 weekly visits (Visits 02, 03, 04, and 05), the subject's daily dose of NRP104 may be increased or decreased by 20 mg at weekly intervals to achieve the optimal efficacy and tolerability, if deemed appropriate by the Investigator. In this study, the maximum daily dose of NRP104 that can be received by the subject is 70 mg, and the minimum daily dose of NRP104 the subject must take to continue the treatment is 30 mg.
Monthly Maintenance
At the end of the initial 4-week dose titration (Visit 05), subjects will enter the long-term maintenance of up to 11 months. Monthly visits, starting with Visit 06, will have a window of ±4 days. All visits will be scheduled relative to the Baseline Visit date. The last scheduled visit of the protocol is Visit 16 at Month 12. During the long-term maintenance, the subject's dose may be increased or decreased by 20 mg at any visit, if deemed appropriate by the Investigator, to maintain optimal treatment in terms of efficacy and tolerability. All reasons for dose changes should be well documented by the investigator during the maintenance period. Subjects who cannot maintain the minimum daily dose of NRP 30 mg due to intolerance will be withdrawn from the study.
Safety and Efficacy Assessments
ADHD Rating Scale (ADHD-RS) performed using adult prompts and Clinical Global Impression (CGI) will be assessed by the Investigator. The Pittsburgh Sleep Quality Index (PSQI) will be assessed once every three months following baseline.
Adverse events and concomitant medications will be recorded at each visit starting from the baseline visit. Vital signs will be measured at each visit from the screening visit. Physical exam and clinical laboratory tests (including pregnancy tests) will be assessed at Screening, Visit 10 and the final visit. Weight will be measured at the screening visit, baseline visit, and every month thereafter. Height will be measured at the screening visit and final visit. ECG parameters will be assessed at the screening visit, baseline visit, and every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Vyvanse (lisdexamfetamine dimesylate), NRP104NRP104 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 | Drug | 1 |
Primary outcome
Change in ADHD-RS-IV Total Score From Baseline at Up to One Year
Time frame: up to one year
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.
2 secondary outcomes
Number of Participants With Improvement on CGI-I
Time frame: Up to 1 year
Change in PSQI Total Score From Baseline at Up to One Year
Time frame: up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21438796Ginsberg L, Katic A, Adeyi B, Dirks B, Babcock T, Lasser R, Scheckner B, Adler LA. Long-term treatment outcomes with lisdexamfetamine dimesylate for adults with attention-deficit/hyperactivity disorder stratified by baseline severity. Curr Med Res Opin. 2011 Jun;27(6):1097-107. doi: 10.1185/03007995.2011.567256. Epub 2011 Mar 28.
- Results publication: PubMed 22808446Mattingly G, Weisler R, Dirks B, Babcock T, Adeyi B, Scheckner B, Lasser R. Attention deficit hyperactivity disorder subtypes and symptom response in adults treated with lisdexamfetamine dimesylate. Innov Clin Neurosci. 2012 May;9(5-6):22-30.
- (FDA Recall Information)Link 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
Massachusetts General Hospital
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vyvanse (lisdexamfetamine dimesylate), NRP104 in people with Attention Deficit Hyperactivity Disorder and Attention Deficit Disorders With Hyperactivity, run by New River Pharmaceuticals at 45 sites in United States.
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 7 inclusion and 8 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 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in ADHD-RS-IV Total Score From Baseline at Up to One Year (time frame: up to one year). 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 NCT00337285, 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 20 Aug 2012.