Attention-Deficit/Hyperactivity DisorderPhase 4NCT01156051
Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
A Phase 4 study testing Guanfacine extended-release tablets in people with Attention-Deficit/Hyperactivity Disorder and Attention Deficit Disorder, run by Children's Specialized Hospital at 2 sites in United States.
Trial summary
This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder, Attention Deficit Disorder, Insomnia
- What is being tested?
- Guanfacine extended-release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Feb 2012
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject must be male or female, aged 6 - 12 years with ADHD.
- Subject must (a) be taking methylphenidate, amphetamine, or atomoxetine for treatment of ADHD with parent or subject concerns of inadequate efficacy or intolerable side effects, or (b) free of any other medication used to treat ADHD for at least 30 days at the time of the initial sleep study.
- Subject must have repeated difficulty with sleep initiation or persistence despite attempts at adequate sleep hygiene.
- Subject must be able to swallow tablets.
Who cannot join
- Subject or parent/LAR is unable or unwilling to discontinue present medications used to treat ADHD.
- Subject has a body mass index < 5th percentile for age, using the Centers for Disease Control standards reported in 2000.
- Subject has a body weight > 176 pounds.
- Subject has a diagnosis of Autism or Autism Spectrum Disorder.
- Subject has other serious psychiatric diagnoses.
- Subject has a medical condition that may require treatment with an unapproved medication, that may cause a safety concern, or that may confound outcome results
- Subject has an excessive caffeine intake (greater than 2.5 mg/kg/d).
- Subject has a prior problem with clonidine or guanfacine.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Specialized Hospital
Hamilton, New Jersey, 08619
Children's Specialized Hospital
Toms River, New Jersey, 08755
About this study
This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.
- Conditions
- Attention-Deficit/Hyperactivity Disorder, Attention Deficit Disorder, Insomnia, Sleep Disorders
- Being tested
- Guanfacine extended-release tablets, Placebo comparator
- Keywords
- ADHD, ADD, sleep disturbance
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guanfacine extended-release tabletsDrug
Also called Intuniv (TM), guanfacine HCl, SPD503
Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated
Placebo comparatorDrug
Also called "sugar pill"
Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).
| Study group | Role | What they receive |
|---|---|---|
| Guanfacine Extended-Release Tablets | Experimental | Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg Receives: Drug: Guanfacine extended-release tablets |
| Placebo comparator | Placebo comparator | Placebo control Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Polysomnographic Total Sleep Time (TST)
Change in objective measures of sleep, using polysomnography
Measured: Baseline to last observation carried forward (after at least one week of dose stability)
Secondary outcomes (3)
Change in Baseline to Treatment ADHD-Rating Scale IV Total Score
Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total. This scale quantitates ADHD symptoms based on DSM-IV criteria with a minimum score of 0 and a maximum score of 54 (higher scores suggesting more ADHD symptoms). The total score is a sum of the 9 items on the ADHD Rating Scale IV inattention score and the 9 items on the ADHD Rating Scale IV hyperactivity-impulsivity score (scores for each 0-27).
Measured: Baseline to last observation carried forward (after at least one week of dose stability)
Change in Baseline to Treatment Latency to Persistent Sleep (LPS)
Change in an objective measure of sleep onset, using polysomnography.
Measured: Baseline to last observation carried forward (after at least one week of dose stability)
Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)
Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.
Measured: Baseline to last observation carried forward (after at least one week of dose stability)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: extended beyond completion date; chose to close out rather than renew IRB review
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Specialized Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Thomas Rugino, Children's Specialized Hospital
- Investigators
- Thomas A Rugino, MD, Principal investigator, Children's Specialized Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156051
- Sponsor's protocol ID
- CSHTR-TR-0901
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2010
- Last updated
- 11 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
- ClinicalTrials.gov ID
- NCT01156051
- Acronym / sponsor ID
- CSHTR-TR-0901
- Conditions
- Attention-Deficit/Hyperactivity Disorder, Attention Deficit Disorder, Insomnia, Sleep Disorders
- Keywords
- ADHD, ADD, sleep disturbance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: extended beyond completion date; chose to close out rather than renew IRB review
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Children's Specialized HospitalUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Jun 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.
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 |
|---|---|---|
| Guanfacine Extended-Release Tablets | Experimental | Drug: Guanfacine extended-release tabletsGuanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg |
| Placebo comparator | Placebo comparator | Drug: Placebo comparatorPlacebo control |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject must be male or female, aged 6 - 12 years with ADHD.
- Subject must (a) be taking methylphenidate, amphetamine, or atomoxetine for treatment of ADHD with parent or subject concerns of inadequate efficacy or intolerable side effects, or (b) free of any other medication used to treat ADHD for at least 30 days at the time of the initial sleep study.
- Subject must have repeated difficulty with sleep initiation or persistence despite attempts at adequate sleep hygiene.
- Subject must be able to swallow tablets.
Key exclusion criteria (8 listed)
- Subject or parent/LAR is unable or unwilling to discontinue present medications used to treat ADHD.
- Subject has a body mass index < 5th percentile for age, using the Centers for Disease Control standards reported in 2000.
- Subject has a body weight > 176 pounds.
- Subject has a diagnosis of Autism or Autism Spectrum Disorder.
- Subject has other serious psychiatric diagnoses.
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 |
|---|---|---|
| Guanfacine extended-release tabletsAlso: Intuniv (TM), guanfacine HCl, SPD503Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated | Drug | Guanfacine Extended-Release Tablets |
| Placebo comparatorAlso: "sugar pill"Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine). | Drug | Placebo comparator |
Primary outcome
Change in Polysomnographic Total Sleep Time (TST)
Time frame: Baseline to last observation carried forward (after at least one week of dose stability)
Change in objective measures of sleep, using polysomnography
3 secondary outcomes
Change in Baseline to Treatment ADHD-Rating Scale IV Total Score
Time frame: Baseline to last observation carried forward (after at least one week of dose stability)
Change in Baseline to Treatment Latency to Persistent Sleep (LPS)
Time frame: Baseline to last observation carried forward (after at least one week of dose stability)
Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)
Time frame: Baseline to last observation carried forward (after at least one week of dose stability)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas A Rugino, MD principal investigator
Children's Specialized Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guanfacine extended-release tablets in people with Attention-Deficit/Hyperactivity Disorder and Attention Deficit Disorder, run by Children's Specialized Hospital at 2 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 4 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: stopped early, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 11 Aug 2014). 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 Polysomnographic Total Sleep Time (TST) (time frame: Baseline to last observation carried forward (after at least one week of dose stability)). 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 11 Aug 2014.