Attention Deficit Hyperactivity DisorderNCT02699528
The Effect of Methylphenidate on Primary Enuresis in Children With Attention Deficit Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder and Enuresis, run by Meir Medical Center at 1 site in Israel.
Trial summary
To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Enuresis
- What is being tested?
- methylphenidate
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to May 2017
- Phase
- Observational
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 5 - 10 years receiving a new diagnosis of attention deficit hyperactivity disorder
Who may be able to join
- New diagnosis of attention deficit hyperactivity disorder
- History of primary nocturnal enuresis
- Normal neurological examination
Who cannot join
- Anatomical abnormality of the genitourinary system
- Concommitant treatment, pharmacological/behavioral for enuresis
- Concommitant diurnal enuresis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
florence Katz, MA, 972-52-2584081, florence.katz@clalit.org.il
Omer Raviv, MD, 972-52-8822052, omerol@walla.co.il
About this study
Official title: Does Methylphenidate, Prescribed for Attention Deficit Disorder, Influence Primary Enuresis in These Children?
To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder
Read the detailed description
Children aged 5 - 10 years newly diagnosed with attention deficit hyperactivity disorder who report primary nocturnal enuresis, Investigators will obtain baseline data (from parents/caregivers) on their sleep habits and enuresis characteristics by questionnaire. After 6 weeks of methylphenidate therapy, prescribed for the attention deficit, a new questionnaire will be filled.
- Conditions
- Attention Deficit Hyperactivity Disorder, Enuresis
- Being tested
- methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
Also called Ritalin, Concerta
The drug will be prescribed as indicated for attention deficit disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction in nocturnal enuresis frequency
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natan Watemberg, Meir Medical Center
- Investigators
- Nathan Watemberg, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699528
- Sponsor's protocol ID
- MMC-15-0329
- Status last verified
- Sep 2016
- First submitted
- 2 Feb 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Methylphenidate, Prescribed for Attention Deficit Disorder, Influence Primary Enuresis in These Children?
- ClinicalTrials.gov ID
- NCT02699528
- Acronym / sponsor ID
- MMC-15-0329
- Conditions
- Attention Deficit Hyperactivity Disorder, Enuresis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 4 Mar 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.
To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder
Detailed description
Children aged 5 - 10 years newly diagnosed with attention deficit hyperactivity disorder who report primary nocturnal enuresis, Investigators will obtain baseline data (from parents/caregivers) on their sleep habits and enuresis characteristics by questionnaire. After 6 weeks of methylphenidate therapy, prescribed for the attention deficit, a new questionnaire will be filled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 5 - 10 years receiving a new diagnosis of attention deficit hyperactivity disorder
Key inclusion criteria (3 listed)
- New diagnosis of attention deficit hyperactivity disorder
- History of primary nocturnal enuresis
- Normal neurological examination
Key exclusion criteria (3 listed)
- Anatomical abnormality of the genitourinary system
- Concommitant treatment, pharmacological/behavioral for enuresis
- Concommitant diurnal enuresis
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 |
|---|---|---|
| methylphenidateAlso: Ritalin, ConcertaThe drug will be prescribed as indicated for attention deficit disorder | Drug | – |
Primary outcome
A reduction in nocturnal enuresis frequency
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Nathan Watemberg, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Enuresis, run by Meir Medical Center at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Sep 2016. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence Katz, BA (972-9-7471803, florence.katz@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A reduction in nocturnal enuresis frequency (time frame: 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 16 Sep 2016.