Trial · NCT05957055
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in ADHD symptom scores on the "inattention" scale of the Conners 3 questionnaire | Before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug | Change of ADHD symptom severity, measured as the difference in ADHD symptom score on the "inattention" scale of the Conners 3 questionnaire (completed by patient and parent/legal guardian), assessed by the investigator blinded to patient allocation. |
| Primary | Change in ADHD symptom scores on the "hyperactivity/impulsivity" scale of the Conners 3 questionnaire | Before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug | Change of ADHD symptom severity, measured as the difference in ADHD symptom score on the "hyperactivity/impulsivity" scale of the Conners 3 questionnaire (completed by patient and parent/legal guardian), assessed by the investigator blinded to patient allocation. |
| Primary | The number of adverse events - methylphenidate arm | Events recorded throughout treatment with MPH for 6 months after randomization or cross-over | The number of adverse events coded following the MedDRA dictionary. |
| Primary | The frequency of adverse events - methylphenidate arm | Events recorded throughout treatment with MPH for 6 months after randomization or cross-over. | The frequency of adverse events per patient-month coded following the MedDRA dictionary. |
| Primary | The number of adverse events - lisdexamphetamine arm | Events recorded throughout treatment with LDX for 6 months after randomization or cross-over | The number of adverse events coded following the MedDRA dictionary. |
| Primary | The frequency of adverse events - lisdexamphetamine arm | Events recorded throughout treatment with LDX for 6 months after randomization or cross-over | The frequency of adverse events per patient-month coded following the MedDRA dictionary. |
| Secondary | Change in Type 1 Diabetes Mellitus metabolic control - glycated haemoglobin | Measured after 6 months of MPH or LDX treatment and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration) | Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in glycated haemoglobin (HbA1c). |
| Secondary | Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived percentage percentage time in target range 70-180mg/dL | Measured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days) | Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: percentage of time patient's sensor glucose values were in the target range (70-180mg/dl). |
| Secondary | Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived percentage percentage time below target range <70mg/dL (hypoglycemia) | MMeasured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days) | Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: percentage of time patient's sensor glucose values were in the hypoglycemia range (\<70mg/dl). |
| Secondary | Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived percentage percentage time below target range <54mg/dL (clinically significant hypoglycemia) | Measured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days) | Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: percentage of time patient's sensor glucose values were in the clinically significant hypoglycemia range (\<54mg/dl). |
| Secondary | Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived percentage percentage time above target range >180mg/dL (hyperglycemia) | Measured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days) | Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: percentage of time patient's sensor glucose values were in the hyperglycemia range (\>180mg/dl). |
| Secondary | Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived percentage percentage time above target range >250mg/dL (significant hyperglycemia) | Measured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days) | Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: percentage of time patient's sensor glucose values were in the significant hyperglycemia (\>250mg/dl) range. |
| Secondary | Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived mean sensor glucose | Measured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days) | Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: mean sensor glucose |
| Secondary | Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived coefficient of variation | Measured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days) | Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: coefficient of variation (calculated as the ratio of the standard deviation to mean sensor glucose, expressed as a percentage). |
| Secondary | Improvement of the patient's quality of life (QoL) | Improvement of the patient's quality of life (QoL) measured from baseline (within 2 weeks before PT training), after completion of PT training (week 10th/22nd) and after each 6 months of pharmacotherapy arm | The outcome will be measured using PedsQL 3.2 questionnaires, completed by patient and parent/legal guardian, assessed by an investigator blinded to patient allocation. |
| Secondary | Number of trial participants achieving an improvement in ADHD symptom severity on the basis of Conners 3 "inattention" scale | Measured before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug | Number of trial participants achieving an improvement in ADHD symptom severity of at least 1/3 of the baseline value at the end of a given pharmacological intervention, assessed separately on the basis of Conners 3 "inattention" scale. Endpoint assessment by an investigator blinded to patient allocation. |
| Secondary | Percentage of trial participants achieving an improvement in ADHD symptom severity on the basis of Conners 3 "inattention" scale | Measured before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug | Percentage of trial participants achieving an improvement in ADHD symptom severity of at least 1/3 of the baseline value at the end of a given pharmacological intervention, assessed separately on the basis of Conners 3 "inattention" scale. Endpoint assessment by an investigator blinded to patient allocation. |
| Secondary | Number of trial participants achieving an improvement in ADHD symptom severity on the basis of Conners 3 "hyperactivity/impulsivity" scale | Measured before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug | Number of trial participants achieving an improvement in ADHD symptom severity of at least 1/3 of the baseline value at the end of a given pharmacological intervention, assessed separately on the basis of Conners 3 "hyperactivity/impulsivity" scale. Endpoint assessment by an investigator blinded to patient allocation. |
| Secondary | Percentage of trial participants achieving an improvement in ADHD symptom severity on the basis of Conners 3 "hyperactivity/impulsivity" scale | Measured before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug | Percentage of trial participants achieving an improvement in ADHD symptom severity of at least 1/3 of the baseline value at the end of a given pharmacological intervention, assessed separately on the basis of Conners 3 "hyperactivity/impulsivity" scale. Endpoint assessment by an investigator blinded to patient allocation. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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