Clinical Trial of Efficacy and Safety of Prospecta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

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

Detailed 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".
    

Intervention name(s): Prospecta; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Other intervention name(s): MMH-MAP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind placebo-controlled randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: in children