#1 Clinical Trials Search in Europe

Lisdexamfetamine Dimesylate

Clinical trials are studying Lisdexamfetamine Dimesylate in children and adolescents with attention-deficit hyperactivity disorder (ADHD) and type 1 diabetes. These trials aim to compare treatment effects, especially changes in ADHD symptoms and safety over time. The research is in a phase 2 setting.

Table of contents

Trial overview

The main trial in the source data is a randomized crossover clinical trial that compares Lisdexamfetamine Dimesylate with methylphenidate in pediatric patients with ADHD and type 1 diabetes.[1] The study title says it is looking at two pharmacological therapies and includes both lisdexamphetamine and methylphenidate in children with these two conditions.[1]

Who participates

The trial is designed for pediatric patients, which means children and adolescents.[1] The brief summary says the study population has ADHD and type 1 diabetes.[1]

What is being studied

The study is comparing Lisdexamfetamine Dimesylate with methylphenidate, which is another medicine used in the trial.[1] The goal is to see how each treatment affects ADHD symptoms over time in children and adolescents who also have type 1 diabetes.[1]

The trial uses the names LDX for lisdexamphetamine and MPH for methylphenidate in the outcome description.[1] The study also includes a period before drug treatment, after completion of PTBM, and then compares symptom scores after 6 months of pharmacotherapy.[1]

Main outcomes

The main outcome is the change in ADHD symptom scores on the Conners 3 questionnaire.[1] The trial looks at two parts of the scale: inattention and hyperactivity/impulsivity.[1]

Researchers compare the score before pharmacotherapy with the score after 6 months of treatment for Lisdexamfetamine Dimesylate or methylphenidate.[1] They also assess the same change for the other drug, with the endpoint evaluated by an investigator who is blinded to patient allocation.[1]

Another main endpoint is the number and frequency of adverse events, which are unwanted medical problems reported during the study.[1] These events are described using the MedDRA dictionary, a standard way to record medical terms in research.[1]

Study design and phase

The study is listed as interventional, which means participants receive a treatment as part of the research.[1] It is a Phase 2 trial, so it is focused on learning more about treatment effects and safety in a specific group of patients.[1]

The crossover design means participants are expected to receive more than one treatment during the study, allowing researchers to compare the medicines within the same patient group.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 150 participants.[1]

The source data do not give more details about results, so this article focuses on the study plan, the target population, and the outcomes being measured.[1]

Trial ID Phase Condition studied Status Enrollment
2023-506862-30-00 Phase 2 Attention-deficit hyperactivity disorder; Type 1 diabetes Authorised 150

FAQ

  • Who can take part in trials of Lisdexamfetamine Dimesylate? The trial data describe pediatric patients with ADHD and type 1 diabetes. This means the study is focused on children and adolescents who have both conditions.
  • What are these trials trying to find out? The main goal is to compare Lisdexamfetamine Dimesylate with methylphenidate and measure changes in ADHD symptoms over 6 months. The study also checks how often adverse events are reported.
  • What phase is the study? The trial is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment works and how safe it is in a specific patient group.
  • What conditions are being studied? The study focuses on attention-deficit hyperactivity disorder and type 1 diabetes. It looks at patients who have both conditions at the same time.
  • How is success measured in the trial? Researchers measure ADHD symptom scores using the Conners 3 questionnaire, especially the inattention and hyperactivity/impulsivity scales. They also record adverse events using the MedDRA dictionary.

Ongoing Clinical Trials on Lisdexamfetamine Dimesylate

  • Study on Lisdexamfetamine and Methylphenidate for Children with ADHD and Type 1 Diabetes

    Recruiting

    1 1 1
    Investigated drugs:
    Poland

Glossary

  • Attention-deficit hyperactivity disorder (ADHD): A condition that can cause problems with attention, impulsive behavior, and too much activity.
  • Type 1 diabetes: A long-term condition where the body cannot make enough insulin, so blood sugar must be managed carefully.
  • Pediatric patients: Children and adolescents.
  • Randomized crossover clinical trial: A study design where participants receive more than one treatment at different times, and the order is assigned by chance.
  • Phase 2: An early to middle stage of clinical research that looks more closely at whether a treatment works and how safe it is.
  • Conners 3 questionnaire: A questionnaire used to measure ADHD symptoms such as inattention and hyperactivity/impulsivity.
  • Inattention: Trouble focusing, staying on task, or paying attention.
  • Hyperactivity/impulsivity: Being overly active or acting without thinking first.
  • Adverse events: Unwanted medical problems that happen during a study, whether or not they are caused by the treatment.
  • MedDRA: A standard medical dictionary used to record and group side effects and other unwanted events in research.
  • Pharmacotherapy: Treatment with medicine.
  • PTBM: A step mentioned in the trial before medicine starts; the source does not explain the full meaning, so it is best understood as part of the study process before drug treatment.

References