Autism Spectrum DisorderPhase 2NCT02812368
Clonidine for Sleep Disturbances in Children With Autism Spectrum Disorder
A Phase 2 study testing Clonidine in people with Autism Spectrum Disorder, run by Ohio State University at 1 site in United States.
Trial summary
Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder (ASD) and is the source of considerable stress for the affected individual and family. Sleep plays a role in development and learning processes; thus, the appropriate treatment of sleep disturbance is paramount to optimal outcomes. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Clonidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jan 2017
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- outpatients between 6-14 years of age, inclusive, from underserved populations (i.e., Low SES, racial and ethnic minorities, rural populations);
- diagnosis of Autism Spectrum Disorder based on DSM-V criteria and the ATN assessment protocol;
- mental age ≥ 24 months as determined by the Stanford Binet-Fifth Edition (SB-5) or Mullen Scales of Early Learning (MSEL) (the child must be of a mental age to understand the BI/SH protocol);
- significant sleep disturbance as determined the CSHQ 33-item Total Score of ≥ 48 and one of the following for the past four weeks by parent interview;
- ≥ 30 minutes delayed sleep onset, ≥ 3 times per week
- Sleep association problems, ≥ 3 nights per week, child falls asleep in a location other than his/her bed and requires parental intervention to return to his/her bed
Show all 14Show fewer
- Nighttime Awakenings, ≥ 3 times per week, and child disturbs parent or enters into the parents' bedroom.
- Early Morning Awakenings, before 5 am ≥ 3 times per week and the child disturbs family members
- CGI Severity rating of ≥ 4 (Moderate) by the independent evaluator for sleep onset and/or sleep maintenance disruption at BL 2;
- care provider who can reliably bring subject to clinic visits and provide trustworthy ratings;
- stable dose of psychotropic medications (for at least 4 weeks with no plans to change over the course of the study);
- anticonvulsant if used for mood lability and it is working well;
- stable dose of exogenous melatonin for at least 4 weeks with no plans to change over the course of the study, as long as Phase II eligibility criteria are met prior to enrollment;
- sleep hygiene education responders who have relapsed and meet the Phase II study eligibility criteria
Who cannot join
- DSM-V diagnosis of bipolar disorder;
- subjects who are either melatonin naïve or who have not had an adequate trial of exogenous melatonin (defined as 3-5 mg for ≥ 4 weeks);
- seizure disorder/epilepsy;
- significant physical illness (e.g., serious cardiovascular, liver or renal pathology);
- medications specifically given for insomnia;
- pregnancy or sexually-active females without birth control;
Show all 14Show fewer
- taking supplements or other complementary medical treatments where dose cannot be held at current level for duration of study;
- weight less than 15 kg;
- use of medicines for physical ailments that might interact with CLN or TRZ, such as guanfacine (Tenex, Intuniv), and propranolol (Inderol) or extended release clonidine (Kapvay);
- allergy to CLN or TRZ;
- Sleep Disordered Breathing (SDB) as defined by a total score of ≥ 3 on the CSHQ SDB subscale and parent report;
- prior adequate trial of CLN for sleep disturbance defined as at least 0.2mg q hs for 1 week;
- prior adequate trial of TRZ for sleep disturbance defined as ≥ 50 mg/day for 1 week;
- hyperthyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Nisonger Center
Columbus, Ohio, 43210
About this study
Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder (ASD) and is the source of considerable stress for the affected individual and family. Sleep plays a role in development and learning processes; thus, the appropriate treatment of sleep disturbance is paramount to optimal outcomes. The empirical base for treatments to address sleep in ASD is sparse, despite wide use of pharmacologic agents such as clonidine (CLN) to target sleep disturbance. A randomized, controlled pilot investigation of CLN for sleep disturbance in children with ASD will allow investigators to evaluate the feasibility of conducting a much larger multisite trial to address the general lack of systematic data available to guide practitioners. Subjects will be 16 children, ages 6-14 years, inclusive, with sleep disturbance and ASD. This randomized double-blind, placebo-controlled (PBO), parallel groups study will test the efficacy of CLN following a brief sleep hygiene intervention. Outcome measures include: informant completed sleep questionnaires, daytime behavior questionnaires, and actigraphy. Biomarkers for medication response will include galvanic skin response and skin temperature. Side effects will be monitored throughout the study.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Clonidine, Placebo (for clonidine)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Also called Catapres, Kapvay, Duraclon
Placebo (for clonidine)Drug
Placebo pill manufactured to mimic clonidine
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Experimental | Taken once a day at bedtime; with the dose titrated from 0.05mg to 0.20mg over the course of 6 weeks Receives: Drug: Clonidine |
| Placebo (for clonidine) | Placebo comparator | Taken once a day at bedtime Receives: Drug: Placebo (for clonidine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children's Sleep Habits Questionnaire (CSHQ) Total Score
The primary outcome measure for this study is clinical improvement on the CSHQ (defined as a 30% or greater reduction in the Total Score of the 33 Sleep Items) at 6 weeks compared to baseline. The CSHQ is the most commonly used parent-rated scale to assess sleep disturbance in pediatric populations. It includes 33 items and is rated retrospectively over the previous week by parents to screen for the most common sleep problems. The CSHQ incorporates items related to eight key sleep domains. The eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness. A Total Score of 41 or greater on the CSHQ 33 items has been reported to be an appropriate clinical cut-off for identifying sleep problems in children.
Measured: Change from Baseline to 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Treatment Network, Autism Intervention Research Network on Physical Health
- Responsible party
- Principal investigator, Jill Hollway, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812368
- Sponsor's protocol ID
- 2016H0181
- Status last verified
- Jan 2017
- First submitted
- 14 Jun 2016
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonidine for Sleep Disturbances in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02812368
- Acronym / sponsor ID
- 2016H0181
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Autism Treatment Network, Autism Intervention Research Network on Physical Health
- Study start
- Aug 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Jun 2016 (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.
Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder (ASD) and is the source of considerable stress for the affected individual and family. Sleep plays a role in development and learning processes; thus, the appropriate treatment of sleep disturbance is paramount to optimal outcomes. The empirical base for treatments to address sleep in ASD is sparse, despite wide use of pharmacologic agents such as clonidine (CLN) to target sleep disturbance. A randomized, controlled pilot investigation of CLN for sleep disturbance in children with ASD will allow investigators to evaluate the feasibility of conducting a much larger multisite trial to address the general lack of systematic data available to guide practitioners. Subjects will be 16 children, ages 6-14 years, inclusive, with sleep disturbance and ASD. This randomized double-blind, placebo-controlled (PBO), parallel groups study will test the efficacy of CLN following a brief sleep hygiene intervention. Outcome measures include: informant completed sleep questionnaires, daytime behavior questionnaires, and actigraphy. Biomarkers for medication response will include galvanic skin response and skin temperature. Side effects will be monitored throughout the study.
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 |
|---|---|---|
| Clonidine | Experimental | Drug: ClonidineTaken once a day at bedtime; with the dose titrated from 0.05mg to 0.20mg over the course of 6 weeks |
| Placebo (for clonidine) | Placebo comparator | Drug: Placebo (for clonidine)Taken once a day at bedtime |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- outpatients between 6-14 years of age, inclusive, from underserved populations (i.e., Low SES, racial and ethnic minorities, rural populations);
- diagnosis of Autism Spectrum Disorder based on DSM-V criteria and the ATN assessment protocol;
- mental age ≥ 24 months as determined by the Stanford Binet-Fifth Edition (SB-5) or Mullen Scales of Early Learning (MSEL) (the child must be of a mental age to understand the BI/SH protocol);
- significant sleep disturbance as determined the CSHQ 33-item Total Score of ≥ 48 and one of the following for the past four weeks by parent interview;
- CGI Severity rating of ≥ 4 (Moderate) by the independent evaluator for sleep onset and/or sleep maintenance disruption at BL 2;
Key exclusion criteria (14 listed)
- DSM-V diagnosis of bipolar disorder;
- subjects who are either melatonin naïve or who have not had an adequate trial of exogenous melatonin (defined as 3-5 mg for ≥ 4 weeks);
- seizure disorder/epilepsy;
- significant physical illness (e.g., serious cardiovascular, liver or renal pathology);
- medications specifically given for insomnia;
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 |
|---|---|---|
| ClonidineAlso: Catapres, Kapvay, Duraclon | Drug | Clonidine |
| Placebo (for clonidine)Placebo pill manufactured to mimic clonidine | Drug | Placebo (for clonidine) |
Primary outcome
Change in Children's Sleep Habits Questionnaire (CSHQ) Total Score
Time frame: Change from Baseline to 6 Weeks
The primary outcome measure for this study is clinical improvement on the CSHQ (defined as a 30% or greater reduction in the Total Score of the 33 Sleep Items) at 6 weeks compared to baseline. The CSHQ is the most commonly used parent-rated scale to assess sleep disturbance in pediatric populations. It includes 33 items and is rated retrospectively over the previous week by parents to screen for the most common sleep problems. The CSHQ incorporates items related to eight key sleep domains. The eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness. A Total Score of 41 or greater on the CSHQ 33 items has been reported to be an appropriate clinical cut-off for identifying sleep problems in children.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonidine in people with Autism Spectrum Disorder, run by Ohio State University at 1 site 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 14 inclusion and 14 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: withdrawn, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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 Children's Sleep Habits Questionnaire (CSHQ) Total Score (time frame: Change from Baseline to 6 Weeks). 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 2 Feb 2017.