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Attention Deficit Hyperactivity DisorderPhase 3NCT04569357

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

A Phase 3 study testing Prospekta in people with Attention Deficit Hyperactivity Disorder, run by Materia Medica Holding at 31 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Purpose of the study: evaluate the efficacy and safety of Prospekta in the treatment of attention deficit/hyperactivity disorder in children. Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
Prospekta
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
363 participants
Where
31 sitesRussia
Study dates
20 Nov 2020to 18 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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):
  • 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).
Show all 29Show fewer
  • 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.
  • Often fidgets with or taps hands or feet or squirms in seat.
  • Often leaves seat in situations when remaining seated is expected (e.g., leaves his or her place in the classroom, in the office or other workplace, or in other situations that require remaining in place).
  • Often runs about or climbs in situations where it is inappropriate.
  • Often unable to play or take part in leisure activities quietly.
  • Is often "on the go" acting as if "driven by a motor" (e.g., is unable to be or uncomfortable being still for extended time).
  • Often talks excessively.
  • Often blurts out an answer before a question has been completed (e.g., completes people's sentences; cannot wait for turn in conversation).
  • Often has trouble waiting his/her turn (e.g., while waiting in line).
  • Often interrupts or intrudes on others (e.g., butts into conversations, games, or activities; may start using other people's things without asking or receiving permission).
  • Several inattentive or hyperactive-impulsive symptoms were present before age 12 years.
  • Several inattentive or hyperactive-impulsive symptoms are present in two or more settings, (e.g., at home, school or work; with friends or relatives).
  • There is clear evidence that the symptoms interfere with, or reduce the quality of, social, school, or work functioning.
  • The symptoms do not occur exclusively during the course of schizophrenia or another psychotic disorder and are not better explained by another mental disorder (e.g., mood disorder, anxiety disorder, dissociative disorder, personality disorder, substance intoxication or withdrawal).
  • 4. ADHD-RS-V ≥ 22. 5. Availability of signed information sheet and informed consent form for the parents/adoptive parents for the subject's participation in the clinical trial.

Who cannot join

  • 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).
Show all 22Show fewer
  • 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.
  • Hereditary lactose intolerance, malabsorption due to lactose intolerance including congenital or acquired lactase (or other disaccharide) deficiency, galactosemia.
  • Patients whose parents/adoptive parents will not fulfill the requirements during the study or follow the order of administration of the study drug (SD) products, from the Investigator's point of view.
  • History of treatment noncompliance, mental diseases, alcoholism or drug abuse in parents/adoptive parents which, according to the investigator, will prevent from following the study procedures.
  • Administration of the products outlined in section "Prohibited concomitant therapy" within 1 month prior to enrollment.
  • Patients who have participated in other clinical trials in the past 3 months.
  • The patient's parent/adoptive parent is a study specialist of the center and is directly involved in the study, or is an immediate family member of the Investigator. Spouses, parents, children, or siblings, regardless of whether they are siblings or adopted are considered immediate family members.
  • The patient's parent/adoptive parent works at Materia Medica Holding, i.e. they are employees of the Company, temporary employees on a contract basis or appointed officials responsible for conduction of the study or their immediate family members.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Russia31 sites

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

    Bryansk, 241004

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

    Chelyabinsk, 454087

  • Engels Psychiatric Hospital

    Engel's, 413124

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

    Kazan', 420012

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

    Kazan', 420138

  • Specialized Clinical Psychiatric Hospital # 1/Dispensary department

    Krasnodar, 350007

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

    Moscow, 117997

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

    Moscow, 119602

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

    Moscow, 129110

  • Llc "Nizhmedklinika"

    Nizhny Novgorod, 603159

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

    Nizhny Novgorod, 603950

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

    Orenburg, 460006

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

    Perm, 614990

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

    Rostov-on-Don, 344000

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

    Ryazan, 390026

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

    Saint Petersburg, 192019

  • Llc "Doctrina"

    Saint Petersburg, 197341

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

    Saint Petersburg, 197376

  • LLC "DNA Research Center"

    Saratov, 410005

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

    Saratov, 410012

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

    Saratov, 410028

  • Saratov City Psychoneurological Dispensary

    Saratov, 410038

  • Smolensk Regional Clinical Hospital/Children's neurological department

    Smolensk, 214018

  • Smolensk Regional Clinical Hospital/Pediatric neurological department

    Smolensk, 214018

  • LLC "Sunterra"

    Stavropol, 355000

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

    Stavropol, 355038

  • Regional Clinical Psychoneurological Dispensary/Outpatient clinic # 2

    Tver', 170026

  • Children's City Clinical Hospital of Ulyanovsk city

    Ulyanovsk, 432017

  • Yaroslavl State Medical University/Department of Polyclinic Pediatrics

    Yaroslavl, 150000

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

    Yekaterinburg, 620030

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

    Yekaterinburg, 620144

Other trials in Russia

About this study

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

Purpose of the study:

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

Being tested
Prospekta, Placebo
Keywords
in children
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProspektaDrug

    Also called MMH-MAP

    Oral administration.

  • PlaceboDrug

    Oral administration.

Study groups in NCT04569357
Study groupRoleWhat they receive
ProspektaExperimentalOne 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.
Receives: Drug: Prospekta
PlaceboPlacebo comparatorOne 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: After 8 weeks of treatment

Secondary outcomes (8)

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

    Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of 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, with his/her parents). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity-impulsivity. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for scale is to be formed using summations of all items. The maximum possible number of points is 54. The minimum score is 0. Higher score = more severe ADHD symptoms.

    Measured: After 8 weeks of treatment

  2. Change in Total ADHD-RS-V Attention Deficit Subscale Score

    Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Attention deficit subscale. Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity/impulsivity. The attention deficit items are: (1) Attention to detail; (2) Sustaining attention; (3) Does not seem to listen; (4) Follows instructions; (5) Difficulty organizing; (6) Sustained mental effort; (7) Loses things; (8) Distracted; (9) Forgetful. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for attention deficit subscale is to be formed using summations of all items. The maximum possible number of points is 27. The minimum score is 0. Higher score = more severe ADHD symptoms.

    Measured: After 8 weeks of treatment

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

    Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Hyperactivity/impulsivity subscale. Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity-impulsivity. The hyperactivity/impulsivity items are: (1) Fidgets; (2) Leaves seat; (3) Runs about; (4) Playing quietly; (5) On the go; (6) Talks excessively; (7) Blurts out answers; (8) Awaiting turns; (9) Interrupts or intrudes. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for hyperactivity/impulsivity subscale is to be formed using summations of all items. The maximum possible number of points is 27. The minimum score is 0. Higher score = more severe ADHD symptoms.

    Measured: After 8 weeks of treatment

  4. CGI-EI Efficacy Score

    Clinical Global Impression Efficacy Index (CGI-EI). Rating scale for assessment of the therapeutic effect of treatment and associated side effects. The scale consists of 2 items: therapeutic effect and side effects. Scores in therapeutic effect range from 1 (marked improvement) to 13 (unchanged or worse). Scores in side effects range from 0 (no side effects) to 3 (side effects outweigh therapeutic effects). Efficacy index ranges between 0 and 16. Higher values represent a worse result. CGI-EI is filled out by an investigator. It is necessary to indicate the level of efficacy of the therapy and the grade of safety of the therapy and circle the index values at the intersection of the selected lines.

    Measured: After 8 weeks of treatment

  5. Changes in Vital Signs (Pulse Rate (Heart Rate))

    Based on medical records. Vital signs will be measured in a medical setting.

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

  6. Changes in Vital Signs (Blood Pressure)

    Based on medical records. Vital signs will be measured in a medical setting.

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

  7. Changes in Vital Signs (Respiration Rate (Breaths Per Minute))

    Based on medical records. Vital signs will be measured in a medical setting.

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

  8. Percentage of Patients With Clinically Relevant Laboratory Abnormalities

    Laboratory tests include the following parameters (absolute and relative values): hematology, biochemistry and urinalysis. Laboratory tests will be made by central laboratory.

    Measured: For 8 weeks of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2020
  2. Study start20 Nov 2020
  3. Primary completion18 Feb 2022
  4. Study completion18 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
double-blind placebo-controlled randomized
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04569357
Sponsor's protocol ID
MMH-MAP-004
Status last verified
Nov 2021
First submitted
22 Sep 2020
Last updated
1 Aug 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prospekta in people with Attention Deficit Hyperactivity Disorder, run by Materia Medica Holding at 31 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Total ADHD-RS-V Reduction ≥25% (time frame: After 8 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04569357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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