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

NCT04569357 | Completed Phase 3 Results

• 1 other identifier: MMH-MAP-004
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

in children

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Total ADHD-RS-V Reduction ≥25%

  Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-V). The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). Home version will evaluate behaviour and emotional response in the situations in which the child is with his/her parents. ADHD-RS-V will evaluate 18 symptoms presented as brief characteristics of peculiarities in behaviour and emotional response of children in various situations (at home).

  After 8 weeks of treatment

Secondary Outcomes (8)

• Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score

  After 8 weeks of treatment

• Change in Total ADHD-RS-V Attention Deficit Subscale Score

  After 8 weeks of treatment

• Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score

  After 8 weeks of treatment

• CGI-EI Efficacy Score

  After 8 weeks of treatment

• Changes in Vital Signs (Pulse Rate (Heart Rate))

  Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)

Other Outcomes (3)

• Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity.

  For 8 weeks of the treatment

• Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug.

  For 8 weeks of the treatment

• Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome.

  For 8 weeks of the treatment

Study Arms (2)

Prospekta

EXPERIMENTAL

One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.

Drug: Prospekta

Placebo

PLACEBO COMPARATOR

One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.

Drug: Placebo

Interventions

Prospekta DRUG

Oral administration.

Also known as: MMH-MAP

Prospekta

Placebo DRUG

Oral administration.

Placebo

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children aged 7-12 years old inclusive.
• Children with verified diagnosis of ADHD.
• Presence of all ADHD criteria according to DSM-V (see appendix 1):
• A. persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development, as characterized by (1) and/or (2):
• Attention deficit: Six (or more) of the following symptoms have persisted for at least 6 months to a degree that is inconsistent with developmental level and that negatively impacts directly on social and academic/occupational activities:
• Often fails to give close attention to details or makes careless mistakes in schoolwork, at work, or during other activities (e.g., overlooks or misses details, work is inaccurate).
• Often has difficulty sustaining attention in tasks or play activities (e.g., has difficulty remaining focused during lectures, conversations, or lengthy reading).
• Often does not seem to listen when spoken to directly (e.g., mind seems elsewhere, even in the absence of any obvious distraction).
• Often does not follow through on instructions and fails to finish schoolwork, chores, or duties in the workplace (e.g., starts tasks but quickly loses focus and is easily sidetracked).
• Often has difficulty organizing tasks and activities (e.g., difficulty managing sequential tasks; difficulty keeping materials and belongings in order; messy, disorganized work; has poor time management; fails to meet deadlines).
• Often avoids, dislikes, or is reluctant to engage in tasks that require sustained mental effort (e.g., schoolwork or homework).
• Often loses things necessary for tasks or activities (e.g., school materials, pencils, books, tools, wallets, keys, eyeglasses).
• Is often easily distracted by extraneous stimuli.
• Is often forgetful in daily activities (e.g., doing chores, running errands).
• Hyperactivity/impulsivity: Six (or more) of the following symptoms have persisted for at least 6 months to a degree that is inconsistent with developmental level and that negatively impacts directly on social and academic/occupational activities. Note. The symptoms are not solely a manifestation of oppositional behavior, defiance, hostility, or failure to understand tasks or instructions.

You may not qualify if:

• History of central nervous system (CNS) diseases including:
• Inflammatory diseases of the central nervous system (G00-G09).
• Systemic atrophies primarily affecting the CNS (G10-G13).
• Extrapyramidal and movement disorders (G20-G26).
• Other degenerative diseases of the nervous system (G30-G32).
• Demyelinating diseases of the CNS (G35-G37).
• Epilepsy (G40-41).
• Hydrocephalus (G91).
• Childhood autism (F84.0), atypical autism • (F84.1).
• Mental retardation (F70-79).
• Disorders of psychological development (F80-F89).
• History of hyperthyroidism (thyrotoxicosis).
• History/suspicion of oncology of any location (except for benign neoplasms).
• Any other comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
• Patients allergic to/intolerant of any constituent of the medications used in the treatment.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (31)

Hospital "Russian Railways - Medicine" of the city of Bryansk

Bryansk, 241004, Russia

Location

Regional Clinical Specialized Psychoneurological Hospital # 1/Children's dispensary department

Chelyabinsk, 454087, Russia

Location

Engels Psychiatric Hospital

Engel's, 413124, Russia

Location

Kazan State Medical University/Department of Neurology, Neurosurgery and Medical Genetics

Kazan', 420012, Russia

Location

Children's Republican Clinical Hospital/Neurological department for the treatment of patients with CNS lesions with mental disorders

Kazan', 420138, Russia

Location

Specialized Clinical Psychiatric Hospital # 1/Dispensary department

Krasnodar, 350007, Russia

Location

Russian National Research Medical University named after N.I. Pirogov/Department of Neurology, Neurosurgery and Medical Genetics, Faculty of Pediatrics

Moscow, 117997, Russia

Location

Research and Practical Center of Pediatric Psychoneurology of Moscow City Health Department/Consultative and polyclinic department

Moscow, 119602, Russia

Location

Moscow Regional Research Clinical Institute named after M.F. Vladimirsky/Neurology Department of Therapy Department

Moscow, 129110, Russia

Location

Llc "Nizhmedklinika"

Nizhny Novgorod, 603159, Russia

Location

Privolzhsky Research Medical University/Department of Neurology, Psychiatry and Narcology FDPO

Nizhny Novgorod, 603950, Russia

Location

Orenburg Regional Clinical Psychiatric Hospital # 1/Children's psychiatric department

Orenburg, 460006, Russia

Location

Perm State Medical University named after academician E.A. Wagner/Department of Neurology

Perm, 614990, Russia

Location

LLC "Treatment and rehabilitation research center "PHOENIX"/Day hospital # 1

Rostov-on-Don, 344000, Russia

Location

Ryazan State Medical University named after Acad. I.P. Pavlov/Department of Children's Diseases with a course of hospital pediatrics

Ryazan, 390026, Russia

Location

National Medical Research Center for Psychiatry and Neurology named after V.M. Bekhterev

Saint Petersburg, 192019, Russia

Location

Llc "Doctrina"

Saint Petersburg, 197341, Russia

Location

Institute of the Human Brain named after N.P. Bekhtereva

Saint Petersburg, 197376, Russia

Location

LLC "DNA Research Center"

Saratov, 410005, Russia

Location

Saratov State Medical University named after V.I. Razumovsky/Department of Neurology. named after K.N. Tretyakov

Saratov, 410012, Russia

Location

City Clinical Hospital # 2 named after V.I. Razumovsky

Saratov, 410028, Russia

Location

Saratov City Psychoneurological Dispensary

Saratov, 410038, Russia

Location

Smolensk Regional Clinical Hospital/Children's neurological department

Smolensk, 214018, Russia

Location

Smolensk Regional Clinical Hospital/Pediatric neurological department

Smolensk, 214018, Russia

Location

LLC "Sunterra"

Stavropol, 355000, Russia

Location

Stavropol Regional Clinical Specialized Psychiatric Hospital # 1/Children's department # 17

Stavropol, 355038, Russia

Location

Regional Clinical Psychoneurological Dispensary/Outpatient clinic # 2

Tver', 170026, Russia

Location

Children's City Clinical Hospital of Ulyanovsk city

Ulyanovsk, 432017, Russia

Location

Yaroslavl State Medical University/Department of Polyclinic Pediatrics

Yaroslavl, 150000, Russia

Location

Sverdlovsk Regional Clinical Psychiatric Hospital/Pediatric and adolescent medical and diagnostic department

Yekaterinburg, 620030, Russia

Location

LLC "European Medical Center "UMMC-Health"/Children's polyclinic in the main branch

Yekaterinburg, 620144, Russia

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind placebo-controlled randomized

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 29, 2020
• Study Start: November 20, 2020
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2021-11

Locations

RU (31)