In short
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.
Key points
- Lisdexamfetamine Dimesylate is being studied in a Phase 2 clinical trial for children and adolescents with ADHD and type 1 diabetes. The trial compares it with methylphenidate in a randomized crossover design, so participants receive both treatments at different times. Researchers are mainly looking at changes in ADHD symptom scores after 6 months of treatment. They also record adverse events to learn more about safety in this patient group. The study is authorised and plans to enroll 150 participants.
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. The study title says it is looking at two pharmacological therapies and includes both lisdexamphetamine and methylphenidate in children with these two conditions.
Who participates
The trial is designed for pediatric patients, which means children and adolescents. The brief summary says the study population has ADHD and type 1 diabetes.
What is being studied
The study is comparing Lisdexamfetamine Dimesylate with methylphenidate, which is another medicine used in the trial. The goal is to see how each treatment affects ADHD symptoms over time in children and adolescents who also have type 1 diabetes.
The trial uses the names LDX for lisdexamphetamine and MPH for methylphenidate in the outcome description. The study also includes a period before drug treatment, after completion of PTBM, and then compares symptom scores after 6 months of pharmacotherapy.
Main outcomes
The main outcome is the change in ADHD symptom scores on the Conners 3 questionnaire. The trial looks at two parts of the scale: inattention and hyperactivity/impulsivity.
Researchers compare the score before pharmacotherapy with the score after 6 months of treatment for Lisdexamfetamine Dimesylate or methylphenidate. They also assess the same change for the other drug, with the endpoint evaluated by an investigator who is blinded to patient allocation.
Another main endpoint is the number and frequency of adverse events, which are unwanted medical problems reported during the study. These events are described using the MedDRA dictionary, a standard way to record medical terms in research.
Study design and phase
The study is listed as interventional, which means participants receive a treatment as part of the research. It is a Phase 2 trial, so it is focused on learning more about treatment effects and safety in a specific group of patients.
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.
Trial status and size
The trial status is Authorised. The planned enrollment is 150 participants.
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.