Attention Deficit Disorder With HyperactivityPhase 3NCT00556959
Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study testing high dose clonidine HCl sustained release and low dose clonidine HCl sustained release in people with Attention Deficit Disorder With Hyperactivity, run by Addrenex Pharmaceuticals, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for 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
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- high dose clonidine HCl sustained release and low dose 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
- 236 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2007to Aug 2008
- 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
- Male or female between 6 and 17 years of age, inclusive
- Diagnosis of ADHD of the hyperactive or combined inattentive/hyperactive subtypes according to DSM-IV criteria
- Minimum score of 26 on the ADHDRS-IV questionnaire at Baseline
- General good health as judged by the Principal Investigator
- Body mass index ≥ 5th percentile of the subject's age group according to the CDC growth chart.
- Ability to swallow tablets
- General IQ ≥80 as judged by the Principal Investigator
- Subject as well as parent/guardian able to sign informed assent or consent form.
Who cannot join
- If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or IUD
- Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
- Presence of clinically significant abnormality on centrally interpreted Electrocardiogram (ECG) readings
- History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant Axis I or Axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
- History of concomitant conduct disorder (CD)
- History of seizures, except for a single episode of febrile seizure prior to age 2
Show all 12Show fewer
- History of syncopal episodes
- Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
- History of intolerance to clonidine, including any dermatologic reaction to transdermal clonidine
- Presence or history of alcohol or drug abuse
- Positive drug screen, with the exception of ADHD drugs
- Use of any investigational drug within 30 days of study start.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Chapel Hill, North Carolina, 27514
Study site
Charlotte, North Carolina, 28209
Study site
Clementon, New Jersey, 08021
Study site
Gainesville, Florida, 32607
Study site
Houston, Texas, 77007
Study site
Jacksonville, Florida, 32216
Study site
Lake Jackson, Texas, 77566
Study site
Miami, Florida, 33161
Study site
Oklahoma City, Oklahoma, 73103
Study site
Oklahoma City, Oklahoma, 73116
Study site
Orlando, Florida, 32806
Study site
Rochester Hills, Michigan, 48307
Study site
Voorhees Township, New Jersey, 08043
About this study
Official title: A Phase III, Dose-Response Evaluation of the Efficacy and Safety of CLONICEL® (Clonidine HCl Sustained Release) vs. Placebo in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD).
Read the detailed description
Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively since the early 70s to treat mild to moderate hypertension. In addition to hypertension, clonidine has been evaluated and used extensively for several other indications, including attention deficit hyperactivity disorder (ADHD).
An easy to administer clonidine formulation is needed that retains the efficacy of the current oral formulation but has an improved safety profile. The current trial will investigate the safety and efficacy of clonidine delivered from the sustained release formulation of CLONICEL in the treatment of children and adolescents with ADHD.
- Being tested
- high dose clonidine HCl sustained release, low dose clonidine HCl sustained release, placebo
- Keywords
- ADHD, Clonidine, Attention Deficit, Hyperactivity, CLONICEL, Addrenex
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose clonidine HCl sustained releaseDrug
high dose clonidine HCl sustained release tablets for 8 weeks
low dose clonidine HCl sustained releaseDrug
low dose clonidine HCl sustained release tablets for 8 weeks
placeboDrug
placebo tablets for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CLONICEL High Dose Receives: Drug: high dose clonidine HCl sustained release |
| 2 | Experimental | CLONICEL Low Dose Receives: Drug: low dose clonidine HCl sustained release |
| 3 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHDRS-IV
Measured: Week 5
Secondary outcomes (2)
CPRS-L, CGI-S, and CGI-I
Measured: Week 5
Adverse Events, Laboratory Assessments, Vital Signs, and ECGs
Measured: Throughout Treatment Phase
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 startOct 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addrenex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Moise A Khayrallah, PhD, Study director, Addrenex Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556959
- Sponsor's protocol ID
- CLON-301
- Status last verified
- Aug 2008
- First submitted
- 8 Nov 2007
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Jain R, Segal S, Kollins SH, Khayrallah M. Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):171-9. doi: 10.1016/j.jaac.2010.11.005.
PubMed 21241954
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Dose-Response Evaluation of the Efficacy and Safety of CLONICEL® (Clonidine HCl Sustained Release) vs. Placebo in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00556959
- Acronym / sponsor ID
- CLON-301
- Keywords
- ADHD, Clonidine, Attention Deficit, Hyperactivity, CLONICEL, Addrenex
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Addrenex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (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 determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD).
Detailed description
Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively since the early 70s to treat mild to moderate hypertension. In addition to hypertension, clonidine has been evaluated and used extensively for several other indications, including attention deficit hyperactivity disorder (ADHD).
An easy to administer clonidine formulation is needed that retains the efficacy of the current oral formulation but has an improved safety profile. The current trial will investigate the safety and efficacy of clonidine delivered from the sustained release formulation of CLONICEL in the treatment of children and adolescents 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: high dose clonidine HCl sustained releaseCLONICEL High Dose |
| 2 | Experimental | Drug: low dose clonidine HCl sustained releaseCLONICEL Low Dose |
| 3 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female between 6 and 17 years of age, inclusive
- Diagnosis of ADHD of the hyperactive or combined inattentive/hyperactive subtypes according to DSM-IV criteria
- Minimum score of 26 on the ADHDRS-IV questionnaire at Baseline
- General good health as judged by the Principal Investigator
- Body mass index ≥ 5th percentile of the subject's age group according to the CDC growth chart.
Key exclusion criteria (12 listed)
- If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or IUD
- Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
- Presence of clinically significant abnormality on centrally interpreted Electrocardiogram (ECG) readings
- History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant Axis I or Axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
- History of concomitant conduct disorder (CD)
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 |
|---|---|---|
| high dose clonidine HCl sustained releasehigh dose clonidine HCl sustained release tablets for 8 weeks | Drug | 1 |
| low dose clonidine HCl sustained releaselow dose clonidine HCl sustained release tablets for 8 weeks | Drug | 2 |
| placeboplacebo tablets for 8 weeks | Drug | 3 |
Primary outcome
ADHDRS-IV
Time frame: Week 5
2 secondary outcomes
CPRS-L, CGI-S, and CGI-I
Time frame: Week 5
Adverse Events, Laboratory Assessments, Vital Signs, and ECGs
Time frame: Throughout Treatment Phase
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 24 Mar 2010.
- Derived from this study: PubMed 21241954Jain R, Segal S, Kollins SH, Khayrallah M. Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):171-9. doi: 10.1016/j.jaac.2010.11.005.
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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 A Khayrallah, PhD study director
Addrenex Pharmaceuticals, Inc.
13 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 high dose clonidine HCl sustained release and low dose clonidine HCl sustained release in people with Attention Deficit Disorder With Hyperactivity, run by Addrenex 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 8 inclusion and 12 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 24 Mar 2010. 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 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 (time frame: Week 5). 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 NCT00556959, which also lists 1 linked publication.
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 24 Mar 2010.