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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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

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.

Osama Ibrahim Younes contact

01024188789

osamaebrahim2012@gmail.com

About this study

Official title: Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD

  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 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.

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 groups in NCT06841666
Study groupRoleWhat they receive
Group 1 (Treatment)Experimental50 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)Experimental50 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.

  1. 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)
  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.

  1. First posted24 Feb 2025
  2. Study start28 Feb 2025 (estimated)
  3. Primary completion30 Aug 2025 (estimated)
  4. Study completion5 Sep 2025 (estimated)

Resources

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)
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

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