ADHDPhase 2NCT01876719
AR08 for Treatment of ADHD in Children
A Phase 2 study testing AR08 in people with ADHD, run by Arbor Pharmaceuticals, Inc. at 13 sites in United States.
Trial summary
This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- AR08
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 13 sitesUnited States
- Study dates
- Jun 2013to Feb 2015
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on structured clinical interview, MINI-KID, as assessed by the Investigator
- Minimum score of 28 on the ADHD-RS-IV at Baseline
- Male or female ages 6 - 17 years, inclusive, at the time of Screening
- Weighs ≥21 kg (46 pounds).
- Is functioning at age appropriate levels intellectually, as deemed by the Investigator.
Who cannot join
- Has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be established by the MINI-KID interview).
- Has a positive response to either question 4 or 5 of the Baseline /Screening version of the pediatric Columbia Suicide Severity Rating Scale (C-SSRS)
- History of daily usage (at least 28 days/month) of either anti-hypertensive or prophylactic anti-migraine medications prior to Screening
- Current usage of medications known to cause QTc prolongation or ADHD medications.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Florida Clinical Research Center, LLC
Brandenton, Florida, 34201
Neuroscience Associates
Herndon, Virginia, 20170
Bayou City Research Ltd.
Houston, Texas, 77007
Houston Clinical Trials
Houston, Texas, 77098
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
CNS Healthcare
Memphis, Tennessee, 38119
Segal Institute for Clinical Research
North Miami, Florida, 33161
CNS Healthcare
Orlando, Florida, 32806
Midwest Research Group at St. Charles Psychiatric Associates
Saint Charles, Missouri, 63304
Miami Research Associates
South Miami, Florida, 33143
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Forced Titration, Proof-of-Concept Study of AR08 in the Treatment of Attention Deficit Hyperactivity Disorder in Children (Ages 6 - 17)
This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Each patient will receive AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.
- Conditions
- ADHD
- Being tested
- AR08, Placebo
- Keywords
- ADHD, AR08, adrenergic receptor agonists, randomized, placebo-controlled clinical trial
- 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.
AR08Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg AR08 | Experimental | 0.5 mg AR08, QD for 7 weeks Receives: Drug: AR08 |
| 1.0 mg AR08 | Experimental | 1.0 mg AR08, QD for 7 weeks Receives: Drug: AR08 |
| 2.0 mg AR08 | Experimental | 2.0 mg AR08, QD for 7 weeks Receives: Drug: AR08 |
| Placebo | Placebo comparator | Placebo, QD for 7 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-RS-IV
The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35).
Measured: Day 35
Secondary outcomes (3)
CGI-ADHD-S/I
CGI-ADHD-S (severity) and I (improvement) - change from Baseline.
Measured: Day 35
Conners' Parent Rating Scale
Conners' Parent Rating Scale (CPRS-R-S) will be assessed through Day 49.
Measured: Day 49
Columbia Suicide Severity Rating Scale (C-SSRS)
Columbia Suicide Severity Rating Scale (C-SSRS) - incident rate will be assessed through Day 49.
Measured: Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence Downey, MD, Study director, Arbor Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876719
- Sponsor's protocol ID
- AR08.001
- Status last verified
- Nov 2015
- First submitted
- 11 Jun 2013
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Forced Titration, Proof-of-Concept Study of AR08 in the Treatment of Attention Deficit Hyperactivity Disorder in Children (Ages 6 - 17)
- ClinicalTrials.gov ID
- NCT01876719
- Acronym / sponsor ID
- AR08.001
- Conditions
- ADHD
- Keywords
- ADHD, AR08, adrenergic receptor agonists, randomized, placebo-controlled clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Jun 2013 (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 is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Each patient will receive AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.
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 |
|---|---|---|
| 0.5 mg AR08 | Experimental | Drug: AR080.5 mg AR08, QD for 7 weeks |
| 1.0 mg AR08 | Experimental | Drug: AR081.0 mg AR08, QD for 7 weeks |
| 2.0 mg AR08 | Experimental | Drug: AR082.0 mg AR08, QD for 7 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, QD for 7 weeks |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on structured clinical interview, MINI-KID, as assessed by the Investigator
- Minimum score of 28 on the ADHD-RS-IV at Baseline
- Male or female ages 6 - 17 years, inclusive, at the time of Screening
- Weighs ≥21 kg (46 pounds).
- Is functioning at age appropriate levels intellectually, as deemed by the Investigator.
Key exclusion criteria (4 listed)
- Has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be established by the MINI-KID interview).
- Has a positive response to either question 4 or 5 of the Baseline /Screening version of the pediatric Columbia Suicide Severity Rating Scale (C-SSRS)
- History of daily usage (at least 28 days/month) of either anti-hypertensive or prophylactic anti-migraine medications prior to Screening
- Current usage of medications known to cause QTc prolongation or ADHD medications.
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 |
|---|---|---|
| AR08 | Drug | 0.5 mg AR08, 1.0 mg AR08, 2.0 mg AR08 |
| Placebo | Drug | Placebo |
Primary outcome
ADHD-RS-IV
Time frame: Day 35
The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35).
3 secondary outcomes
CGI-ADHD-S/I
Time frame: Day 35
Conners' Parent Rating Scale
Time frame: Day 49
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 49
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 9 Dec 2015.
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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.
Laurence Downey, MD study director
Arbor Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR08 in people with ADHD, run by Arbor Pharmaceuticals, Inc. at 13 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 5 inclusion and 4 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 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. 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?
ADHD-RS-IV (time frame: Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2015.