ADHDEarly Phase 1NCT06841666
Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD: A Randomized, Placebo-Controlled Study
A Early Phase 1 study testing Atomoxetine in people with ADHD and Primary Nocturnal Enuresis, run by Tanta University.
Trial summary
1. Primary Aim: To evaluate the efficacy of atomoxetine in reducing the frequency of primary nocturnal enuresis episodes in children with ADHD. 2. Secondary Aim: To determine if improvements in attention symptoms correlate with reductions in nocturnal enuresis episodes. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Primary Nocturnal Enuresis
- What is being tested?
- Atomoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2025to 5 Sep 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-12 years diagnosed with ADHD per Conners-48 scale. Children experiencing primary nocturnal enuresis.
Who cannot join
- Secondary causes of enuresis (e.g., urinary tract infections, diabetes). Use of other enuresis treatments. Known contraindications to atomoxetine.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD
- Primary Aim: To evaluate the efficacy of atomoxetine in reducing the frequency of primary nocturnal enuresis episodes in children with ADHD.
- Secondary Aim: To determine if improvements in attention symptoms correlate with reductions in nocturnal enuresis episodes.
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental disorder affecting approximately 5-7% of school-aged children globally. It is characterized by inattention, hyperactivity, and impulsivity, impairing academic, social, and daily functioning (American Psychiatric Association, 2013). The Conners-48 scale is frequently used to assess ADHD severity, offering a standardized tool for research and clinical practice. Treatments for ADHD often combine behavioral therapies with pharmacological agents such as stimulants or non-stimulants, including atomoxetine (Cortese et al., 2016).
Primary nocturnal enuresis (PNE) refers to involuntary urination during sleep in children aged five or older, without any underlying organic or neurological disorder. While PNE typically diminishes with age, its persistence can cause significant psychosocial stress for children and their families. Studies suggest that children with ADHD experience PNE at higher rates than their neurotypical peers, underscoring the need for tailored management strategies (Hagerty et al., 2015).
Interrelationship Between ADHD and Enuresis:
Shared neurobiological pathways may explain the coexistence of ADHD and PNE. Both conditions involve dysregulation in arousal and inhibitory control mechanisms, leading to disrupted sleep patterns and impaired bladder control during sleep (Shreeram et al., 2009). Despite this overlap, current treatment paradigms rarely address both conditions concurrently, leaving a clinical gap in care.
Rationale for Atomoxetine in PNE:
Atomoxetine, a selective norepinephrine reuptake inhibitor, is a non-stimulant ADHD medication effective for managing attention deficits and impulsivity. It may also influence bladder control by enhancing norepinephrine activity in brainstem regions implicated in micturition (Kim et al., 2015). This potential dual benefit positions atomoxetine as a promising treatment option for ADHD and comorbid PNE.
Clinical and Research Gap:
Although extensive research has validated atomoxetine's efficacy for ADHD, limited studies explore its effects on comorbid conditions like PNE. This study aims to evaluate the frequency of nocturnal enuresis episodes and changes in ADHD symptoms, providing insight into atomoxetine's potential dual benefits. Findings may inform integrated therapeutic approaches for children with ADHD and PNE.
- Conditions
- ADHD, Primary Nocturnal Enuresis
- Being tested
- Atomoxetine, Placebo
- Keywords
- Primary Nocturnal Enuresis, ADHD, Atomoxetine
- 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.
AtomoxetineDrug
Atomoxetine, 0.5-1.2 mg/kg/day, administered in the evening for six months.
PlaceboDrug
Placebo identical in form and dosing schedule for six months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Treatment) | Experimental | 50 patients will recieve Atomoxetine, 0.5-1.2 mg/kg/day, administered in the evening for six months.
Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log. ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months. Receives: Drug: Atomoxetine |
| Group 2 (Control) | Experimental | 50 participants will receive Placebo identical in form and dosing schedule. for 6 months.
Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log. ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log.
- Baseline data: enuresis frequency.
- Follow-up assessments at 1, 3, and 6 months:
Parent-maintained logs of enuresis episodes.
Measured: 6months
Secondary outcomes (1)
ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months
- Baseline data: demographic details, ADHD severity (Conners-48),
- Follow-up assessments at 1, 3, and 6 months:
- Conners-48 scores to monitor ADHD symptom changes.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start28 Feb 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion5 Sep 2025 (estimated)
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 ADHDStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Placebo-Controlled Study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Ibrahim Younes, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841666
- Sponsor's protocol ID
- 36264؛ٌ1054/1/25
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meredith SE, Juliano LM, Hughes JR, Griffiths RR. Caffeine Use Disorder: A Comprehensive Review and Research Agenda. J Caffeine Res. 2013 Sep;3(3):114-130. doi: 10.1089/jcr.2013.0016.
PubMed 24761279
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD
- ClinicalTrials.gov ID
- NCT06841666
- Acronym / sponsor ID
- 36264؛ٌ1054/1/25
- Conditions
- ADHD, Primary Nocturnal Enuresis
- Keywords
- Primary Nocturnal Enuresis, ADHD, Atomoxetine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 5 Sep 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- 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.
- Primary Aim: To evaluate the efficacy of atomoxetine in reducing the frequency of primary nocturnal enuresis episodes in children with ADHD.
- Secondary Aim: To determine if improvements in attention symptoms correlate with reductions in nocturnal enuresis episodes.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental disorder affecting approximately 5-7% of school-aged children globally. It is characterized by inattention, hyperactivity, and impulsivity, impairing academic, social, and daily functioning (American Psychiatric Association, 2013). The Conners-48 scale is frequently used to assess ADHD severity, offering a standardized tool for research and clinical practice. Treatments for ADHD often combine behavioral therapies with pharmacological agents such as stimulants or non-stimulants, including atomoxetine (Cortese et al., 2016).
Primary nocturnal enuresis (PNE) refers to involuntary urination during sleep in children aged five or older, without any underlying organic or neurological disorder. While PNE typically diminishes with age, its persistence can cause significant psychosocial stress for children and their families. Studies suggest that children with ADHD experience PNE at higher rates than their neurotypical peers, underscoring the need for tailored management strategies (Hagerty et al., 2015).
Interrelationship Between ADHD and Enuresis:
Shared neurobiological pathways may explain the coexistence of ADHD and PNE. Both conditions involve dysregulation in arousal and inhibitory control mechanisms, leading to disrupted sleep patterns and impaired bladder control during sleep (Shreeram et al., 2009). Despite this overlap, current treatment paradigms rarely address both conditions concurrently, leaving a clinical gap in care.
Rationale for Atomoxetine in PNE:
Atomoxetine, a selective norepinephrine reuptake inhibitor, is a non-stimulant ADHD medication effective for managing attention deficits and impulsivity. It may also influence bladder control by enhancing norepinephrine activity in brainstem regions implicated in micturition (Kim et al., 2015). This potential dual benefit positions atomoxetine as a promising treatment option for ADHD and comorbid PNE.
Clinical and Research Gap:
Although extensive research has validated atomoxetine's efficacy for ADHD, limited studies explore its effects on comorbid conditions like PNE. This study aims to evaluate the frequency of nocturnal enuresis episodes and changes in ADHD symptoms, providing insight into atomoxetine's potential dual benefits. Findings may inform integrated therapeutic approaches for children with ADHD and PNE.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized, Placebo-Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Treatment) | Experimental | Drug: Atomoxetine50 patients will recieve Atomoxetine, 0.5-1.2 mg/kg/day, administered in the evening for six months. Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log. ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months. |
| Group 2 (Control) | Experimental | Drug: Placebo50 participants will receive Placebo identical in form and dosing schedule. for 6 months. Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log. ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6-12 years diagnosed with ADHD per Conners-48 scale. Children experiencing primary nocturnal enuresis.
Key exclusion criteria (1 listed)
- Secondary causes of enuresis (e.g., urinary tract infections, diabetes). Use of other enuresis treatments. Known contraindications to atomoxetine.
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 |
|---|---|---|
| AtomoxetineAtomoxetine, 0.5-1.2 mg/kg/day, administered in the evening for six months. | Drug | Group 1 (Treatment) |
| PlaceboPlacebo identical in form and dosing schedule for six months. | Drug | Group 2 (Control) |
Primary outcome
Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log.
Time frame: 6months
* Baseline data: enuresis frequency. * Follow-up assessments at 1, 3, and 6 months: Parent-maintained logs of enuresis episodes.
1 secondary outcome
ADHD symptoms, assessed using Conners-48 scores at baseline, 1, 3, and 6 months
Time frame: 6months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Results publication: PubMed 24761279Meredith SE, Juliano LM, Hughes JR, Griffiths RR. Caffeine Use Disorder: A Comprehensive Review and Research Agenda. J Caffeine Res. 2013 Sep;3(3):114-130. doi: 10.1089/jcr.2013.0016.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Atomoxetine in people with ADHD and Primary Nocturnal Enuresis, run by Tanta University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama Ibrahim Younes (01024188789, osamaebrahim2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log. (time frame: 6months). 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 NCT06841666, 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 27 Feb 2025.