ADHDPhase 3NCT00641329
CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
A Phase 3 study testing CLONICEL (clonidine HCl sustained release) in people with ADHD, run by Addrenex Pharmaceuticals, Inc. at 23 sites in United States.
Trial summary
The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- CLONICEL (clonidine HCl sustained release)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 23 sitesUnited States
- Study dates
- Feb 2008to Feb 2009
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-17 years, inclusive
- Diagnosis of ADHD
- Currently on a stable psychostimulant regimen for ADHD
- Lack of adequate response to stable psychostimulant regimen
- Ability to swallow tablets
Who cannot join
- Clinically significant illnesses or abnormalities upon evaluation
- Conduct Disorder
- Intolerance to clonidine
- History of seizures or syncope
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Study site
Baltimore, Maryland, 21208
Study site
Bardstown, Kentucky, 40004
Study site
Bradenton, Florida, 34208
Study site
Chapel Hill, North Carolina, 27514
Study site
Clementon, New Jersey, 08021
Study site
Cleveland, Ohio, 44106
Study site
Clinton, Utah, 84015
Study site
Durham, North Carolina, 27705
Study site
El Centro, California, 92243
Study site
Houston, Texas, 77007
Study site
Houston, Texas, 77074
Study site
Irvine, California, 92612
Study site
Kirkland, Washington, 98033
Study site
Lake Jackson, Texas, 77566
Study site
Lauderhill, Florida, 33319
Study site
Little Rock, Arkansas, 72205
Study site
Miami, Florida, 33161
Study site
Oklahoma City, Oklahoma, 73103
Study site
Oklahoma City, Oklahoma, 73116
Study site
San Diego, California, 92103
Study site
Spokane, Washington, 99202
Study site
St Louis, Missouri, 63005
Study site
Wharton, Texas, 77488
About this study
Official title: Phase III Evaluation of the Safety and Efficacy of CLONICEL (Clonidine HCl Sustained Release) as Add-on to Psychostimulant Medication vs. Psychostimulant Medication Alone in Children and Adolescents With ADHD
The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).
- Conditions
- ADHD
- Being tested
- CLONICEL (clonidine HCl sustained release), Placebo
- Keywords
- ADHD, ADD, Attention Deficit Hyperactivity Disorder, Attention Deficit, Clonidine, CLONICEL, Addrenex
- 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.
CLONICEL (clonidine HCl sustained release)Drug
Flexible Dose (0.1 - 0.4 mg)
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CLONICEL (clonidine HCl sustained release) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHDRS-IV Total Score
Measured: Week 5
Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
Measured: Throughout Treatment and Follow-up Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addrenex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Moise Khayrallah, PhD, Study director, Addrenex Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641329
- Sponsor's protocol ID
- CLON-302
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2008
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Evaluation of the Safety and Efficacy of CLONICEL (Clonidine HCl Sustained Release) as Add-on to Psychostimulant Medication vs. Psychostimulant Medication Alone in Children and Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT00641329
- Acronym / sponsor ID
- CLON-302
- Conditions
- ADHD
- Keywords
- ADHD, ADD, Attention Deficit Hyperactivity Disorder, Attention Deficit, Clonidine, CLONICEL, Addrenex
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Addrenex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Mar 2008 (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 determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CLONICEL (clonidine HCl sustained release) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6-17 years, inclusive
- Diagnosis of ADHD
- Currently on a stable psychostimulant regimen for ADHD
- Lack of adequate response to stable psychostimulant regimen
- Ability to swallow tablets
Key exclusion criteria (4 listed)
- Clinically significant illnesses or abnormalities upon evaluation
- Conduct Disorder
- Intolerance to clonidine
- History of seizures or syncope
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 |
|---|---|---|
| CLONICEL (clonidine HCl sustained release)Flexible Dose (0.1 - 0.4 mg) | Drug | 1 |
| PlaceboMatching placebo tablets | Drug | 2 |
Primary outcome
ADHDRS-IV Total Score
Time frame: Week 5
Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
Time frame: Throughout Treatment and Follow-up Period
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 Apr 2010.
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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.
Moise Khayrallah, PhD study director
Addrenex Pharmaceuticals
23 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 CLONICEL (clonidine HCl sustained release) in people with ADHD, run by Addrenex Pharmaceuticals, Inc. at 23 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 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 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?
ADHDRS-IV Total Score (time frame: Week 5). The study lists 2 primary outcomes in all. 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 Apr 2010.