Attention Deficit Hyperactivity Disorder (ADHD)Phase 4PHACYLOBNCT07121621
PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder
A Phase 4 study testing PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity. in people with Attention Deficit Hyperactivity Disorder (ADHD) and Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2), run by University Hospital, Tours at 1 site in France.
Trial summary
PHACYLOB PHArmaCokinetics of methYLphenidate in adult patients with Attention-Deficit Hyperactivity Disorder (ADHD) : comparison between patients with and without OBesity. Its aim is to determine whether, for a comparable treatment dose, there are differences in the pharmacokinetic of methylphenidate between ADHD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD), Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2), Methylphenidate
- What is being tested?
- PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 2 Sep 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and over
- Diagnosis of ADHD by a psychiatrist, based on DSM-5 criteria (ADHD mixed form, predominantly inattentive or predominantly hyperactive/impulsive)
- Treatment with methylphenidate LP (Ritaline) with a stable dosage for at least two weeks.
- BMI inclusion criteria: (1) for obese group: BMI ≥ 30 kg/m2; (2) for non-obese group: BMI < 30 kg/m2.
- Participant affiliated to a social security scheme
- Written consent signed by participant
Who cannot join
- Contraindications to methylphenidate treatment
- Treatment with an oral or nasal decongestant vasoconstrictor; association with a non-selective MAOI antidepressant.
- Treatment with a proton pump inhibitor within the last 2 weeks.
- Severe cognitive impairment (clinical evaluation)
- Severe alcohol use disorder, i.e. at least 6 DSM-5 criteria for substance use disorder (clinical evaluation)
- Known prior renal impairment
Show all 10Show fewer
- Pregnant or breast-feeding women
- Female patients of childbearing age without at least one acceptable contraceptive method (see definition in Appendix 1)
- Patients under legal protection
- Inability of the patient to self-assess the intensity of ADHD symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Center Hospitalier Régional Universitaire of TOURS
Tours, Indre-et-Loire, 37044
Paul BRUNAULT, MD and PhD, 02 18 37 05 81, paul.brunault@univ-tours.fr
Valérie GISSOT, MD, 02 34 37 96 53, valerie.gissot@univ-tours.fr
About this study
Official title: PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder: Comparison Between Patients With and Without OBesity
PHACYLOB PHArmaCokinetics of methYLphenidate in adult patients with Attention-Deficit Hyperactivity Disorder (ADHD) : comparison between patients with and without OBesity.
Its aim is to determine whether, for a comparable treatment dose, there are differences in the pharmacokinetic of methylphenidate between ADHD patients with obesitý and ADHD patients but without obesitý. More specifically, we will assess whether blood concentrations of methylphenidate (MPH; long acting form) are significantly higher or lower in either group at different times of the day.
To meet this objective, we are conducting this pharmacokinetic clinical trial with blood sampling and repeated clinical measurements just prior to MPH administration (= at T0) and then, at different times after administration, i.e. at times (T): T 30 minutes, T 1 hour, T2h, T3h, T4h, T6h, T8h after MPH administration. As far as MPH is concerned, this is the usual treatment. However, we may hypothesize that the distribution in the body may differ according to weight: hence the interest of this study
Read the detailed description
The various phases of the study will take place at the Tours University Hospital:
- Patient selection (Department of Addictions): Eligibility assessment by the psychiatrist consulting patients with ADHD. Information regarding the study, risks, and constraints associated with the study.
- Patient inclusion (CIC 1415): Signed consent after informing the patient about the protocol, risks, and constraints. Collection of demographic and medical data, ADHD symptom intensity (ASRS-18), and individual psychological characteristics (emotional dysregulation: DERS-36, impulsivity: UPPS-P, binge eating disorder: BES).
- Clinical and laboratory assessments prior to MPH administration (CIC 1415): Blood pressure, NPF, serum creatinine, and complete liver function tests.
- MPH administration (CIC 1415): MPH LP is taken at the patient's usual dosage in the early morning.
- Repeated blood samples (CIC 1415) to measure plasma concentrations of MPH and APP before drug administration (T0), i.e., a pre-administration sample, then at T30 minutes (+/- 10 min), T1h (+/- 10 min), T2h (+/- 30 min), T3h (+/- 30 min), T4h (+/- 30 min), T6h (+/- 30 min), and T8h (+/- 30 min) after MPH administration. Clinical Research Nurses will accurately note the exact sampling times on the venous sampling accompanying sheets, including any differences from the theoretical schedule, in order to limit bias. Samples will be collected using sodium heparin trace element tubes, without separator gel (royal blue cap with black collar). These venous samples will be sent to and stored at the Biological Resources Center of Touraine (CRB-T). In addition, two aliquots must be taken and stored by the CRB-T. For each sample, one aliquot must be sent to the Medical Pharmacology Department and the second retained for safety.
- Assessment of perceived efficacy and tolerance of treatment (CIC 1415): visual analog scale allowing self-assessment of ADHD symptoms according to the patient at T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h and the effect on food craving; clinical assessment of treatment tolerance at T4h and T8h.
- Patient discharged home, in the absence of serious adverse side effects.
- Pharmacokinetic analysis and modeling (Medical Pharmacology Department): transfer from the CRB-T at the end of the study, plasma assays, pharmacokinetic modeling based on patient data.
- Note: For pharmacokinetic analysis, 6 mL of blood will be collected in sodium heparin tubes over the 8 sampling times. A total of 48 mL of blood will therefore be collected per patient on their day of participation. These samples will ultimately be destroyed after the results have been analyzed.
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD), Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2), Methylphenidate, Obesity &Amp; Overweight
- Being tested
- PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity.
- Keywords
- Methylphenidate, Attention Deficit Hyperactivity Disorder (ADHD), Obesity, Pharmacokinetics
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity.Drug
The pharmacological intervention, which will be the same for all patients in the study, will consist in administering MPH at CIC 1415 (URHC of Tours) in the form of Prolonged Release at the patient's usual dosage, in the early morning.
Pharmacokinetic study with repeated measurements at T0 (just before MPH administration) then T30 minutes, T1 hour, T2h, T3h, T4h, T6h, T8h (8 measurements) after MPH administration, in 15 patients with ADHD and obesity (BMI≥30 kg/m2) and in 15 patients with ADHD but without obesity (BMI<30 kg/m2).
| Study group | Role | What they receive |
|---|---|---|
| PHArmacoKinetics of methYLphenidate in adult patients with ADHD | Experimental | PHArmacoKinetics of methYLphenidate in adult patients with ADHD: patients with OBesity.
PHArmacoKinetics of methYLphenidate in adult patients with ADHD: patients without OBesity. Receives: Drug: PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of blood concentrations of MPH and APP, its active metabolite, measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration, compared between patients with and without obesity.
The primary endpoint is the area under the curve (AUC) of blood concentrations of MPH and APP, its active metabolite, measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration, compared between patients with and without obesity.
Measured: Anticipated recruitment period: 12 months / Duration of each subject's participation: 1 day / Total duration of research: 12 months and 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion2 Sep 2026 (estimated)
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The pharmacological intervention, which will be the same for all patients in the study, will consist in administering MPH at CIC 1415 (URHC of Tours) in the form of Prolonged Release at the patient's usual dosage, in the early morning. Compare the total area under the curve (AUC) of MPH and alpha-phenyl 2 piperidine acid (APP), its active metabolite, between patients with ADHD and obesity and patients with ADHD but without obesity. Pharmacokinetic study with repeated measurements at T0 (just before MPH administration) then T30 minutes, T1 hour, T2h, T3h, T4h, T6h, T8h (8 measurements) after MPH administration, in 15 patients with ADHD and obesity (BMI≥30 kg/m2) and in 15 patients with ADHD but without obesity (BMI\<30 kg/m2).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121621
- Sponsor's protocol ID
- DR240305
- Other IDs
- 2024-519461-22-00
- Acronym
- PHACYLOB
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faraone SV, Banaschewski T, Coghill D, Zheng Y, Biederman J, Bellgrove MA, Newcorn JH, Gignac M, Al Saud NM, Manor I, Rohde LA, Yang L, Cortese S, Almagor D, Stein MA, Albatti TH, Aljoudi HF, Alqahtani MMJ, Asherson P, Atwoli L, Bolte S, Buitelaar JK, Crunelle CL, Daley D, Dalsgaard S, Dopfner M, Espinet S, Fitzgerald M, Franke B, Gerlach M, Haavik J, Hartman CA, Hartung CM, Hinshaw SP, Hoekstra PJ, Hollis C, Kollins SH, Sandra Kooij JJ, Kuntsi J, Larsson H, Li T, Liu J, Merzon E, Mattingly G, Mattos P, McCarthy S, Mikami AY, Molina BSG, Nigg JT, Purper-Ouakil D, Omigbodun OO, Polanczyk GV, Pollak Y, Poulton AS, Rajkumar RP, Reding A, Reif A, Rubia K, Rucklidge J, Romanos M, Ramos-Quiroga JA, Schellekens A, Scheres A, Schoeman R, Schweitzer JB, Shah H, Solanto MV, Sonuga-Barke E, Soutullo C, Steinhausen HC, Swanson JM, Thapar A, Tripp G, van de Glind G, van den Brink W, Van der Oord S, Venter A, Vitiello B, Walitza S, Wang Y. The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder. Neurosci Biobehav Rev. 2021 Sep;128:789-818. doi: 10.1016/j.neubiorev.2021.01.022. Epub 2021 Feb 4.
PubMed 33549739Brunault P, Frammery J, Montaudon P, De Luca A, Hankard R, Ducluzeau PH, Cortese S, Ballon N. Adulthood and childhood ADHD in patients consulting for obesity is associated with food addiction and binge eating, but not sleep apnea syndrome. Appetite. 2019 May 1;136:25-32. doi: 10.1016/j.appet.2019.01.013. Epub 2019 Jan 11.
PubMed 30641157
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder: Comparison Between Patients With and Without OBesity
- ClinicalTrials.gov ID
- NCT07121621
- Acronym / sponsor ID
- PHACYLOB / DR240305
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD), Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2), Methylphenidate, Obesity &Amp; Overweight
- Keywords
- Methylphenidate, Attention Deficit Hyperactivity Disorder (ADHD), Obesity, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 13 Aug 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.
PHACYLOB PHArmaCokinetics of methYLphenidate in adult patients with Attention-Deficit Hyperactivity Disorder (ADHD) : comparison between patients with and without OBesity.
Its aim is to determine whether, for a comparable treatment dose, there are differences in the pharmacokinetic of methylphenidate between ADHD patients with obesitý and ADHD patients but without obesitý. More specifically, we will assess whether blood concentrations of methylphenidate (MPH; long acting form) are significantly higher or lower in either group at different times of the day.
To meet this objective, we are conducting this pharmacokinetic clinical trial with blood sampling and repeated clinical measurements just prior to MPH administration (= at T0) and then, at different times after administration, i.e. at times (T): T 30 minutes, T 1 hour, T2h, T3h, T4h, T6h, T8h after MPH administration. As far as MPH is concerned, this is the usual treatment. However, we may hypothesize that the distribution in the body may differ according to weight: hence the interest of this study
Detailed description
The various phases of the study will take place at the Tours University Hospital:
- Patient selection (Department of Addictions): Eligibility assessment by the psychiatrist consulting patients with ADHD. Information regarding the study, risks, and constraints associated with the study.
- Patient inclusion (CIC 1415): Signed consent after informing the patient about the protocol, risks, and constraints. Collection of demographic and medical data, ADHD symptom intensity (ASRS-18), and individual psychological characteristics (emotional dysregulation: DERS-36, impulsivity: UPPS-P, binge eating disorder: BES).
- Clinical and laboratory assessments prior to MPH administration (CIC 1415): Blood pressure, NPF, serum creatinine, and complete liver function tests.
- MPH administration (CIC 1415): MPH LP is taken at the patient's usual dosage in the early morning.
- Repeated blood samples (CIC 1415) to measure plasma concentrations of MPH and APP before drug administration (T0), i.e., a pre-administration sample, then at T30 minutes (+/- 10 min), T1h (+/- 10 min), T2h (+/- 30 min), T3h (+/- 30 min), T4h (+/- 30 min), T6h (+/- 30 min), and T8h (+/- 30 min) after MPH administration. Clinical Research Nurses will accurately note the exact sampling times on the venous sampling accompanying sheets, including any differences from the theoretical schedule, in order to limit bias. Samples will be collected using sodium heparin trace element tubes, without separator gel (royal blue cap with black collar). These venous samples will be sent to and stored at the Biological Resources Center of Touraine (CRB-T). In addition, two aliquots must be taken and stored by the CRB-T. For each sample, one aliquot must be sent to the Medical Pharmacology Department and the second retained for safety.
- Assessment of perceived efficacy and tolerance of treatment (CIC 1415): visual analog scale allowing self-assessment of ADHD symptoms according to the patient at T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h and the effect on food craving; clinical assessment of treatment tolerance at T4h and T8h.
- Patient discharged home, in the absence of serious adverse side effects.
- Pharmacokinetic analysis and modeling (Medical Pharmacology Department): transfer from the CRB-T at the end of the study, plasma assays, pharmacokinetic modeling based on patient data.
- Note: For pharmacokinetic analysis, 6 mL of blood will be collected in sodium heparin tubes over the 8 sampling times. A total of 48 mL of blood will therefore be collected per patient on their day of participation. These samples will ultimately be destroyed after the results have been analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The pharmacological intervention, which will be the same for all patients in the study, will consist in administering MPH at CIC 1415 (URHC of Tours) in the form of Prolonged Release at the patient's usual dosage, in the early morning. Compare the total area under the curve (AUC) of MPH and alpha-phenyl 2 piperidine acid (APP), its active metabolite, between patients with ADHD and obesity and patients with ADHD but without obesity. Pharmacokinetic study with repeated measurements at T0 (just before MPH administration) then T30 minutes, T1 hour, T2h, T3h, T4h, T6h, T8h (8 measurements) after MPH administration, in 15 patients with ADHD and obesity (BMI≥30 kg/m2) and in 15 patients with ADHD but without obesity (BMI<30 kg/m2).
| Arm | Type | Receives |
|---|---|---|
| PHArmacoKinetics of methYLphenidate in adult patients with ADHD | Experimental | Drug: PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity.PHArmacoKinetics of methYLphenidate in adult patients with ADHD: patients with OBesity. PHArmacoKinetics of methYLphenidate in adult patients with ADHD: patients without OBesity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 and over
- Diagnosis of ADHD by a psychiatrist, based on DSM-5 criteria (ADHD mixed form, predominantly inattentive or predominantly hyperactive/impulsive)
- Treatment with methylphenidate LP (Ritaline) with a stable dosage for at least two weeks.
- BMI inclusion criteria: (1) for obese group: BMI ≥ 30 kg/m2; (2) for non-obese group: BMI < 30 kg/m2.
- Participant affiliated to a social security scheme
Key exclusion criteria (10 listed)
- Contraindications to methylphenidate treatment
- Treatment with an oral or nasal decongestant vasoconstrictor; association with a non-selective MAOI antidepressant.
- Treatment with a proton pump inhibitor within the last 2 weeks.
- Severe cognitive impairment (clinical evaluation)
- Severe alcohol use disorder, i.e. at least 6 DSM-5 criteria for substance use disorder (clinical evaluation)
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 |
|---|---|---|
| PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity.The pharmacological intervention, which will be the same for all patients in the study, will consist in administering MPH at CIC 1415 (URHC of Tours) in the form of Prolonged Release at the patient's usual dosage, in the early morning. Pharmacokinetic study with repeated measurements at T0 (just before MPH administration) then T30 minutes, T1 hour, T2h, T3h, T4h, T6h, T8h (8 measurements) after MPH administration, in 15 patients with ADHD and obesity (BMI≥30 kg/m2) and in 15 patients with ADHD but without obesity (BMI<30 kg/m2). | Drug | PHArmacoKinetics of methYLphenidate in adult patients with ADHD |
Primary outcome
Area under the curve (AUC) of blood concentrations of MPH and APP, its active metabolite, measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration, compared between patients with and without obesity.
Time frame: Anticipated recruitment period: 12 months / Duration of each subject's participation: 1 day / Total duration of research: 12 months and 1 day
The primary endpoint is the area under the curve (AUC) of blood concentrations of MPH and APP, its active metabolite, measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration, compared between patients with and without obesity.
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 13 Aug 2025.
- Background: PubMed 33549739Faraone SV, Banaschewski T, Coghill D, Zheng Y, Biederman J, Bellgrove MA, Newcorn JH, Gignac M, Al Saud NM, Manor I, Rohde LA, Yang L, Cortese S, Almagor D, Stein MA, Albatti TH, Aljoudi HF, Alqahtani MMJ, Asherson P, Atwoli L, Bolte S, Buitelaar JK, Crunelle CL, Daley D, Dalsgaard S, Dopfner M, Espinet S, Fitzgerald M, Franke B, Gerlach M, Haavik J, Hartman CA, Hartung CM, Hinshaw SP, Hoekstra PJ, Hollis C, Kollins SH, Sandra Kooij JJ, Kuntsi J, Larsson H, Li T, Liu J, Merzon E, Mattingly G, Mattos P, McCarthy S, Mikami AY, Molina BSG, Nigg JT, Purper-Ouakil D, Omigbodun OO, Polanczyk GV, Pollak Y, Poulton AS, Rajkumar RP, Reding A, Reif A, Rubia K, Rucklidge J, Romanos M, Ramos-Quiroga JA, Schellekens A, Scheres A, Schoeman R, Schweitzer JB, Shah H, Solanto MV, Sonuga-Barke E, Soutullo C, Steinhausen HC, Swanson JM, Thapar A, Tripp G, van de Glind G, van den Brink W, Van der Oord S, Venter A, Vitiello B, Walitza S, Wang Y. The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder. Neurosci Biobehav Rev. 2021 Sep;128:789-818. doi: 10.1016/j.neubiorev.2021.01.022. Epub 2021 Feb 4.
- Background: PubMed 30641157Brunault P, Frammery J, Montaudon P, De Luca A, Hankard R, Ducluzeau PH, Cortese S, Ballon N. Adulthood and childhood ADHD in patients consulting for obesity is associated with food addiction and binge eating, but not sleep apnea syndrome. Appetite. 2019 May 1;136:25-32. doi: 10.1016/j.appet.2019.01.013. Epub 2019 Jan 11.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity. in people with Attention Deficit Hyperactivity Disorder (ADHD) and Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2), run by University Hospital, Tours at 1 site 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 6 inclusion and 10 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 13 Aug 2025. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Paul BRUNAULT, MD and PhD (02 18 37 05 81, paul.brunault@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of blood concentrations of MPH and APP, its active metabolite, measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration, compared between patients with and without obesity. (time frame: Anticipated recruitment period: 12 months / Duration of each subject's participation: 1 day / Total duration of research: 12 months and 1 day). 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 NCT07121621, which also lists 2 linked publications.
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 13 Aug 2025.