EpilepsyNCT01482026
Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale and Epilepsy
A study testing ADHD Rating Scale-IV in people with Epilepsy, run by Hospices Civils de Lyon at 15 sites in France.
Trial summary
The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- ADHD Rating Scale-IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 15 sitesFrance
- Study dates
- Nov 2011to Dec 2015
- Phase
- Interventional
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 6 to 15 years and 11 months;
- male or female;
- with a diagnosis of ADHD : predominantly inattentive or combined hyperactive-impulsive and inattentive according to the DSM IV criteria;
- children who agreed to participate to the protocol and whose legal representatives have clearly expressed their non-opposition to participate.
Who cannot join
- Patients below 6 years old or patients older than 16 years;
- with a diagnosis of ADHD predominantly hyperactive-impulsive subtype ADHD according to the DSM IV criteria;
- mental retardation defined by a score < 70 at the verbal comprehension index and the perceptual reasoning score of the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV)
- established diagnosis of any psychiatric co-morbidity other than ADHD according to the DSM IV criteria (pervasive developmental disorders including autism, bipolar disorder, psychotic disorder).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Service de Neurologie pédiatrique, CHU d'Amiens
Amiens, 80054
Service de Neurologie Pédiatrique, CHU d'Angers
Angers, 49033
Service de Neurologie pédiatrique, CHU de Besançon
Besançon, 25030
Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin
Bordeaux, 33076
Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant
Bron, 69677
Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer
Bron, 69677
Service d'épileptologie pédiatrique, CHR de Chambéry
Chambéry, 73011
Cabinet Médical du Dr ISNARD
Lyon, 69002
Service de Neurologie pédiatrique, Hôpital de la Timone
Marseille, 13385
Service de Neurologie Pédiatrique, Hôpital Robert-Debré
Paris, 75019
Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades
Paris, 75743
Service de Pédiatrie, Hôpital Sud
Rennes, 35203
Centre Référent des Epilepsies Rares, Hôpital de Hautepierre
Strasbourg, 67098
Service de Neurologie Pédiatrique, Hôpital des Enfants
Toulouse, 31059
Service de Neurologie Pédiatrique, CHU de Tours
Tours, 37044
About this study
Official title: Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study
The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences.
In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.
- Conditions
- Epilepsy
- Being tested
- ADHD Rating Scale-IV
- Keywords
- Epilepsy, Attention deficit, ADHD rating scale IV
- Medical subject headings
- Epilepsy, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHD Rating Scale-IVOther
ADHD Rating Scale-IV test
ADHD Rating Scale-IVOther
ADHD Rating Scale-IV test
| Study group | Role | What they receive |
|---|---|---|
| Treated patients | Experimental | Patients for whom ADHD treatment is introduced at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore Receives: Other: ADHD Rating Scale-IV |
| Non treated patients | Experimental | Patients for whom no ADHD treatment is required at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore Receives: Other: ADHD Rating Scale-IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the ADHD rating scale IV inattention subscore
Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks.
Measured: Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks
Secondary outcomes (2)
Evolution of the ADHD rating scale IV global score
Evolution of the ADHD rating scale IV global score in treated versus non treated patients, after 12 to 16 weeks.
Measured: Change from baseline in ADHD rating scale IV global score at 12 to16 weeks
Evolution of the ADHD rating scale IV hyperactivity subscore
Evolution of the ADHD rating scale IV hyperactivity subscore in treated versus non treated patients, after 12 to 16 weeks.
Measured: Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionDec 2015
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 EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain RHEIMS, MD, Principal investigator, Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482026
- Sponsor's protocol ID
- 2011.682/25
- Status last verified
- Jan 2016
- First submitted
- 24 Nov 2011
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mercier C, Roche S, Gaillard S, Kassai B, Arzimanoglou A, Herbillon V, Roy P, Rheims S. Partial validation of a French version of the ADHD-rating scale IV on a French population of children with ADHD and epilepsy. Factorial structure, reliability, and responsiveness. Epilepsy Behav. 2016 May;58:1-6. doi: 10.1016/j.yebeh.2016.02.016. Epub 2016 Mar 15.
PubMed 26991745
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study
- ClinicalTrials.gov ID
- NCT01482026
- Acronym / sponsor ID
- 2011.682/25
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Attention deficit, ADHD rating scale IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Nov 2011 (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.
The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences.
In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated patients | Experimental | Other: ADHD Rating Scale-IVPatients for whom ADHD treatment is introduced at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore |
| Non treated patients | Experimental | Other: ADHD Rating Scale-IVPatients for whom no ADHD treatment is required at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged 6 to 15 years and 11 months;
- male or female;
- with a diagnosis of ADHD : predominantly inattentive or combined hyperactive-impulsive and inattentive according to the DSM IV criteria;
- children who agreed to participate to the protocol and whose legal representatives have clearly expressed their non-opposition to participate.
Key exclusion criteria (4 listed)
- Patients below 6 years old or patients older than 16 years;
- with a diagnosis of ADHD predominantly hyperactive-impulsive subtype ADHD according to the DSM IV criteria;
- mental retardation defined by a score < 70 at the verbal comprehension index and the perceptual reasoning score of the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV)
- established diagnosis of any psychiatric co-morbidity other than ADHD according to the DSM IV criteria (pervasive developmental disorders including autism, bipolar disorder, psychotic disorder).
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 |
|---|---|---|
| ADHD Rating Scale-IVADHD Rating Scale-IV test | Other | Treated patients |
| ADHD Rating Scale-IVADHD Rating Scale-IV test | Other | Non treated patients |
Primary outcome
Evolution of the ADHD rating scale IV inattention subscore
Time frame: Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks
Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks.
2 secondary outcomes
Evolution of the ADHD rating scale IV global score
Time frame: Change from baseline in ADHD rating scale IV global score at 12 to16 weeks
Evolution of the ADHD rating scale IV hyperactivity subscore
Time frame: Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publication: PubMed 26991745Mercier C, Roche S, Gaillard S, Kassai B, Arzimanoglou A, Herbillon V, Roy P, Rheims S. Partial validation of a French version of the ADHD-rating scale IV on a French population of children with ADHD and epilepsy. Factorial structure, reliability, and responsiveness. Epilepsy Behav. 2016 May;58:1-6. doi: 10.1016/j.yebeh.2016.02.016. Epub 2016 Mar 15.
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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.
Sylvain RHEIMS, MD principal investigator
Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHD Rating Scale-IV in people with Epilepsy, run by Hospices Civils de Lyon at 15 sites in France.
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 4 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: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of the ADHD rating scale IV inattention subscore (time frame: Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks). 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 NCT01482026, 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 9 Sep 2025.