Clinical trial NCT04569357: Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: in children
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 363
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind placebo-controlled randomized
Primary purpose: TREATMENT

Brief summary: Purpose of the study:

• evaluate the efficacy and safety of Prospekta 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 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".

Eligibility criteria: Inclusion Criteria:

1. Male and female children aged 7-12 years old inclusive.
2. Children with verified diagnosis of ADHD.
3. 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):

1. 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).
2. 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).

B. Several inattentive or hyperactive-impulsive symptoms were present before age 12 years.

C. Several inattentive or hyperactive-impulsive symptoms are present in two or more settings, (e.g., at home, school or work; with friends or relatives).

D. There is clear evidence that the symptoms interfere with, or reduce the quality of, social, school, or work functioning.

E. 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.

Exclusion Criteria:

1. 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).
2. Childhood autism (F84.0), atypical autism • (F84.1).
3. Mental retardation (F70-79).
4. Disorders of psychological development (F80-F89).
5. History of hyperthyroidism (thyrotoxicosis).
6. History/suspicion of oncology of any location (except for benign neoplasms).
7. Any other comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
8. Patients allergic to/intolerant of any constituent of the medications used in the treatment.
9. Hereditary lactose intolerance, malabsorption due to lactose intolerance including congenital or acquired lactase (or other disaccharide) deficiency, galactosemia.
10. 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.
11. 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.
12. Administration of the products outlined in section "Prohibited concomitant therapy" within 1 month prior to enrollment.
13. Patients who have participated in other clinical trials in the past 3 months.
14. 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.
15. 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.

Primary outcomes:
measure: Percentage of Patients With Total ADHD-RS-V Reduction ≥25%
timeFrame: After 8 weeks of treatment
Secondary outcomes:
measure: Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score
timeFrame: After 8 weeks of treatment
measure: Change in Total ADHD-RS-V Attention Deficit Subscale Score
timeFrame: After 8 weeks of treatment
measure: Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score
timeFrame: After 8 weeks of treatment
measure: CGI-EI Efficacy Score
timeFrame: After 8 weeks of treatment
measure: Changes in Vital Signs (Pulse Rate (Heart Rate))
timeFrame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
measure: Changes in Vital Signs (Blood Pressure)
timeFrame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
measure: Changes in Vital Signs (Respiration Rate (Breaths Per Minute))
timeFrame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
measure: Percentage of Patients With Clinically Relevant Laboratory Abnormalities
timeFrame: For 8 weeks of the treatment
Other outcomes:
measure: Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity.
timeFrame: For 8 weeks of the treatment
measure: Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug.
timeFrame: For 8 weeks of the treatment
measure: Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome.
timeFrame: For 8 weeks of the treatment
Locations:
city: Bryansk
country: Russian Federation
facility: Hospital "Russian Railways - Medicine" of the city of Bryansk
city: Chelyabinsk
country: Russian Federation
facility: Regional Clinical Specialized Psychoneurological Hospital # 1/Children's dispensary department
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Psychiatric Hospital/Pediatric and adolescent medical and diagnostic department
city: Ekaterinburg
country: Russian Federation
facility: LLC "European Medical Center "UMMC-Health"/Children's polyclinic in the main branch
city: Engels
country: Russian Federation
facility: Engels Psychiatric Hospital
city: Kazan
country: Russian Federation
facility: Kazan State Medical University/Department of Neurology, Neurosurgery and Medical Genetics
city: Kazan
country: Russian Federation
facility: Children's Republican Clinical Hospital/Neurological department for the treatment of patients with CNS lesions with mental disorders
city: Krasnodar
country: Russian Federation
facility: Specialized Clinical Psychiatric Hospital # 1/Dispensary department
city: Moscow
country: Russian Federation
facility: Russian National Research Medical University named after N.I. Pirogov/Department of Neurology, Neurosurgery and Medical Genetics, Faculty of Pediatrics
city: Moscow
country: Russian Federation
facility: Research and Practical Center of Pediatric Psychoneurology of Moscow City Health Department/Consultative and polyclinic department
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute named after M.F. Vladimirsky/Neurology Department of Therapy Department
city: Nizhny Novgorod
country: Russian Federation
facility: Llc "Nizhmedklinika"
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsky Research Medical University/Department of Neurology, Psychiatry and Narcology FDPO
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Psychiatric Hospital # 1/Children's psychiatric department
city: Perm
country: Russian Federation
facility: Perm State Medical University named after academician E.A. Wagner/Department of Neurology
city: Rostov-on-Don
country: Russian Federation
facility: LLC "Treatment and rehabilitation research center "PHOENIX"/Day hospital # 1
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University named after Acad. I.P. Pavlov/Department of Children's Diseases with a course of hospital pediatrics
city: Saint Petersburg
country: Russian Federation
facility: National Medical Research Center for Psychiatry and Neurology named after V.M. Bekhterev
city: Saint Petersburg
country: Russian Federation
facility: Llc "Doctrina"
city: Saint Petersburg
country: Russian Federation
facility: Institute of the Human Brain named after N.P. Bekhtereva
city: Saratov
country: Russian Federation
facility: LLC "DNA Research Center"
city: Saratov
country: Russian Federation
facility: Saratov State Medical University named after V.I. Razumovsky/Department of Neurology. named after K.N. Tretyakov
city: Saratov
country: Russian Federation
facility: City Clinical Hospital # 2 named after V.I. Razumovsky
city: Saratov
country: Russian Federation
facility: Saratov City Psychoneurological Dispensary
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital/Children's neurological department
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital/Pediatric neurological department
city: Stavropol
country: Russian Federation
facility: LLC "Sunterra"
city: Stavropol
country: Russian Federation
facility: Stavropol Regional Clinical Specialized Psychiatric Hospital # 1/Children's department # 17
city: Tver
country: Russian Federation
facility: Regional Clinical Psychoneurological Dispensary/Outpatient clinic # 2
city: Ulyanovsk
country: Russian Federation
facility: Children's City Clinical Hospital of Ulyanovsk city
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medical University/Department of Polyclinic Pediatrics
Study officials:
References: