Clinical Trial of Efficacy and Safety of Prospecta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Prospecta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children

Status Completed

Clinical Trial Summary

Purpose of the study:

• evaluate the efficacy and safety of Prospecta in the treatment of attention deficit/hyperactivity disorder in children.

Clinical Trial Description

Design: a multicenter double-blind placebo-controlled parallel-group randomized clinical trial.

The study will enroll children of either age from 7 to 12 years old with diagnosis of attention deficit/hyperactivity disorder (ADHD) verified by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, American Psychiatric Association" [DSM-V]).

After signing patient information sheet and informed consent form by the subject's parent/adoptive parent collection of complaints, medical examination of the children, filling Attention Deficit Hyperactivity Disorder-Rating Scale-V [ADHD-RS-V]) scale by the parent/adoptive parent will be performed, concomitant therapy will be recorded and laboratory tests will be carried out.

The study will enroll children with total score ADHD-RS-V ≥ 22. If the inclusion criteria were met and there were no exclusion criteria (Day 1), the patient will be randomized to one of the two groups: group 1 will receive Prospecta at 1 tablet twice daily; group 2 will receive Placebo using the study drug dosing regimen.

Treatment period will be 8 weeks, the key examination stages (collection of complaints, recording objective examination findings, repeated filling ADHD-RS-V by parent/adoptive parent) will be made at Visit 1 (Day 1), further in 4 weeks (visit 2) and in 8 weeks (visit 3). Each visit to the research center will be made by the subject accompanied by his/her parent/adoptive parent. Two weeks later (visit 1.1, week 2±3 days) after randomization and initiation of the study therapy and between visits 2 and 3 (visits 2.2, week 6±3 days) the investigator will examine the patient's clinical status (during phone calls). Based on complaints, monitoring of the prescribed therapy therapeutic safety will be assessed. At visit 2 (week 4±3 days) and visit 3 (week 8±3 days) the investigator will collect complaints, record objective examination findings, monitor repeated ADHD-RS-V filling by parent/adoptive parent, the prescribed and concomitant therapy, evaluate therapeutic safety and compliance. In addition at Visit 3 the investigator will complete the Clinical Global Impression Efficacy Index [CGI-EI] scale and collect samples for laboratory testing. The study treatments will be completed.

The total length of the observation period is 8 weeks. During the study the treatment for underlying conditions will be allowed with the exception of the drugs indicated in the section "Prohibited concomitant therapy". ;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

• NCT number: NCT04569357
• Study type: Interventional
• Source: Materia Medica Holding
• Status: Completed
• Phase: Phase 3
• Start date: November 20, 2020
• Completion date: February 18, 2022