Attention Deficit Hyperactivity Disorder
Conditions
Keywords
in children
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.
Interventions
DRUGProspekta
Oral administration.
DRUGPlacebo
Oral administration.
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
double-blind placebo-controlled randomized
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Total ADHD-RS-V Reduction ≥25% | After 8 weeks of treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGI-EI Efficacy Score | After 8 weeks of treatment | 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. |
| Changes in Vital Signs (Blood Pressure) | Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks) | Based on medical records. Vital signs will be measured in a medical setting. |
| Changes in Vital Signs (Respiration Rate (Breaths Per Minute)) | Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks) | Based on medical records. Vital signs will be measured in a medical setting. |
| Percentage of Patients With Clinically Relevant Laboratory Abnormalities | For 8 weeks of the treatment | Laboratory tests include the following parameters (absolute and relative values): hematology, biochemistry and urinalysis. Laboratory tests will be made by central laboratory. |
| Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | After 8 weeks of treatment | 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. |
| Change in Total ADHD-RS-V Attention Deficit Subscale Score | After 8 weeks of treatment | 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. |
| Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | After 8 weeks of treatment | 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. |
| Changes in Vital Signs (Pulse Rate (Heart Rate)) | Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks) | Based on medical records. Vital signs will be measured in a medical setting. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | For 8 weeks of the treatment | Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD. |
| Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | For 8 weeks of the treatment | Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD. |
| Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. | For 8 weeks of the treatment | Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prospekta 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.
Prospekta: Oral administration. | 174 |
| Placebo 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.
Placebo: Oral administration. | 189 |
| Total | 363 |
Baseline characteristics
| Characteristic | Placebo | Total | Prospekta |
|---|---|---|---|
| Age, Categorical <=18 years | 189 Participants | 363 Participants | 174 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.3 years STANDARD_DEVIATION 1.7 | 9.3 years STANDARD_DEVIATION 1.7 | 9.3 years STANDARD_DEVIATION 1.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 189 participants | 363 participants | 174 participants |
| Sex: Female, Male Female | 66 Participants | 130 Participants | 64 Participants |
| Sex: Female, Male Male | 123 Participants | 233 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 174 | 0 / 189 |
| other Total, other adverse events | 23 / 174 | 23 / 189 |
| serious Total, serious adverse events | 0 / 174 | 0 / 189 |
Outcome results
Primary
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).
Time frame: After 8 weeks of treatment
Population: There is no data on the ADHD-RS-V questionnaire after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospekta | Percentage of Patients With Total ADHD-RS-V Reduction ≥25% | 95 Participants |
| Placebo | Percentage of Patients With Total ADHD-RS-V Reduction ≥25% | 81 Participants |
Comparison: Test for comparison percentage of patients with reduction ≥ 25%.p-value: 0.0199Fisher Exact
Secondary
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.
Time frame: After 8 weeks of treatment
Population: There is no data on the CGI-EI scale after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | CGI-EI Efficacy Score | Therapeutic effect | 5.9 score on a scale | Standard Deviation 3.2 |
| Prospekta | CGI-EI Efficacy Score | Side effect | 1.0 score on a scale | Standard Deviation 0.2 |
| Prospekta | CGI-EI Efficacy Score | Efficacy index | 6.9 score on a scale | Standard Deviation 3.2 |
| Placebo | CGI-EI Efficacy Score | Therapeutic effect | 6.9 score on a scale | Standard Deviation 3.1 |
| Placebo | CGI-EI Efficacy Score | Side effect | 1.1 score on a scale | Standard Deviation 0.3 |
| Placebo | CGI-EI Efficacy Score | Efficacy index | 8.0 score on a scale | Standard Deviation 3.1 |
Comparison: Therapeutic effect analysis.p-value: 0.0024Wilcoxon (Mann-Whitney)
Comparison: Side effects analysis.p-value: 0.1722Wilcoxon (Mann-Whitney)
Comparison: Efficacy index analysis.p-value: 0.0012Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: After 8 weeks of treatment
Population: There is no data on the ADHD-RS-V questionnaire after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in Total ADHD-RS-V Attention Deficit Subscale Score | Baseline | 18.4 score on a scale | Standard Deviation 3.3 |
| Prospekta | Change in Total ADHD-RS-V Attention Deficit Subscale Score | After 4 weeks of the treatment | 15.7 score on a scale | Standard Deviation 3.7 |
| Prospekta | Change in Total ADHD-RS-V Attention Deficit Subscale Score | After 8 weeks of the treatment | 13.0 score on a scale | Standard Deviation 4 |
| Prospekta | Change in Total ADHD-RS-V Attention Deficit Subscale Score | ∆ between baseline and after 8 weeks of treatment | 5.4 score on a scale | Standard Deviation 4.3 |
| Placebo | Change in Total ADHD-RS-V Attention Deficit Subscale Score | ∆ between baseline and after 8 weeks of treatment | 4.3 score on a scale | Standard Deviation 4.3 |
| Placebo | Change in Total ADHD-RS-V Attention Deficit Subscale Score | Baseline | 18.3 score on a scale | Standard Deviation 3.5 |
| Placebo | Change in Total ADHD-RS-V Attention Deficit Subscale Score | After 8 weeks of the treatment | 14.0 score on a scale | Standard Deviation 4.7 |
| Placebo | Change in Total ADHD-RS-V Attention Deficit Subscale Score | After 4 weeks of the treatment | 15.7 score on a scale | Standard Deviation 3.7 |
Comparison: Mean changes of ADHD-RS-V scores (attention deficit subscale) after 8 weeks of treatment were compared.p-value: 0.0063Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: After 8 weeks of treatment
Population: There is no data on the ADHD-RS-V questionnaire after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | Baseline | 14.1 score on a scale | Standard Deviation 4.2 |
| Prospekta | Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | After 4 weeks of the treatment | 11.9 score on a scale | Standard Deviation 4 |
| Prospekta | Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | After 8 weeks of the treatment | 9.3 score on a scale | Standard Deviation 4.3 |
| Prospekta | Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | ∆ between baseline and after 8 weeks of treatment | 4.8 score on a scale | Standard Deviation 4.2 |
| Placebo | Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | ∆ between baseline and after 8 weeks of treatment | 3.9 score on a scale | Standard Deviation 4.3 |
| Placebo | Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | Baseline | 14.4 score on a scale | Standard Deviation 4.4 |
| Placebo | Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | After 8 weeks of the treatment | 10.5 score on a scale | Standard Deviation 4.9 |
| Placebo | Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score | After 4 weeks of the treatment | 12.5 score on a scale | Standard Deviation 4.1 |
Comparison: Mean changes of ADHD-RS-V scores (hyperactivity/impulsivity subscale) after 8 weeks of treatment were compared.p-value: 0.0525Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: After 8 weeks of treatment
Population: There is no data on the ADHD-RS-V questionnaire after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | Baseline | 32.5 score on a scale | Standard Deviation 6 |
| Prospekta | Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | After 4 weeks of treatment | 27.6 score on a scale | Standard Deviation 6.2 |
| Prospekta | Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | After 8 weeks of treatment | 22.3 score on a scale | Standard Deviation 7.4 |
| Prospekta | Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | ∆ between baseline and after 8 weeks of treatment | 10.2 score on a scale | Standard Deviation 7.7 |
| Placebo | Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | ∆ between baseline and after 8 weeks of treatment | 8.1 score on a scale | Standard Deviation 7.9 |
| Placebo | Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | Baseline | 32.7 score on a scale | Standard Deviation 6.3 |
| Placebo | Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | After 8 weeks of treatment | 24.6 score on a scale | Standard Deviation 8.7 |
| Placebo | Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score | After 4 weeks of treatment | 28.2 score on a scale | Standard Deviation 6.4 |
Comparison: Mean changes of ADHD-RS-V scores after 8 weeks of treatment were compared.p-value: 0.0096Wilcoxon (Mann-Whitney)
Secondary
Changes in Vital Signs (Blood Pressure)
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Changes in Vital Signs (Blood Pressure) | Diastolic pressure/Visit 2 | 66.8 mmHg | Standard Deviation 6.3 |
| Prospekta | Changes in Vital Signs (Blood Pressure) | Systolic pressure/Visit 1 | 104.5 mmHg | Standard Deviation 9.1 |
| Prospekta | Changes in Vital Signs (Blood Pressure) | Diastolic pressure/Visit 1 | 66.9 mmHg | Standard Deviation 6.5 |
| Prospekta | Changes in Vital Signs (Blood Pressure) | Systolic pressure/Visit 2 | 104.0 mmHg | Standard Deviation 9 |
| Prospekta | Changes in Vital Signs (Blood Pressure) | Diastolic pressure/Visit 3 | 66.6 mmHg | Standard Deviation 5.9 |
| Prospekta | Changes in Vital Signs (Blood Pressure) | Systolic pressure/Visit 3 | 104.1 mmHg | Standard Deviation 9.4 |
| Placebo | Changes in Vital Signs (Blood Pressure) | Diastolic pressure/Visit 3 | 67.0 mmHg | Standard Deviation 6.9 |
| Placebo | Changes in Vital Signs (Blood Pressure) | Systolic pressure/Visit 3 | 104.1 mmHg | Standard Deviation 9.3 |
| Placebo | Changes in Vital Signs (Blood Pressure) | Diastolic pressure/Visit 2 | 66.7 mmHg | Standard Deviation 6.9 |
| Placebo | Changes in Vital Signs (Blood Pressure) | Diastolic pressure/Visit 1 | 66.3 mmHg | Standard Deviation 6.3 |
| Placebo | Changes in Vital Signs (Blood Pressure) | Systolic pressure/Visit 1 | 104.0 mmHg | Standard Deviation 9.3 |
| Placebo | Changes in Vital Signs (Blood Pressure) | Systolic pressure/Visit 2 | 103.8 mmHg | Standard Deviation 9.3 |
Comparison: This analysis applies to Systolic pressure data.p-value: 0.81ANOVA
Comparison: This analysis applies to Diastolic pressure data.p-value: 0.22ANOVA
Secondary
Changes in Vital Signs (Pulse Rate (Heart Rate))
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Changes in Vital Signs (Pulse Rate (Heart Rate)) | Visit 1 | 82.9 beats/min | Standard Deviation 9.2 |
| Prospekta | Changes in Vital Signs (Pulse Rate (Heart Rate)) | Visit 2 | 83.1 beats/min | Standard Deviation 8.2 |
| Prospekta | Changes in Vital Signs (Pulse Rate (Heart Rate)) | Visit 3 | 81.9 beats/min | Standard Deviation 8.8 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)) | Visit 1 | 82.4 beats/min | Standard Deviation 9.5 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)) | Visit 2 | 82.3 beats/min | Standard Deviation 8.3 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)) | Visit 3 | 82.4 beats/min | Standard Deviation 8.1 |
p-value: 0.13ANOVA
Secondary
Changes in Vital Signs (Respiration Rate (Breaths Per Minute))
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Changes in Vital Signs (Respiration Rate (Breaths Per Minute)) | Visit 1 | 19.9 breaths per minute | Standard Deviation 2.5 |
| Prospekta | Changes in Vital Signs (Respiration Rate (Breaths Per Minute)) | Visit 2 | 20.0 breaths per minute | Standard Deviation 2.6 |
| Prospekta | Changes in Vital Signs (Respiration Rate (Breaths Per Minute)) | Visit 3 | 20.1 breaths per minute | Standard Deviation 3 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breaths Per Minute)) | Visit 1 | 20.3 breaths per minute | Standard Deviation 2.8 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breaths Per Minute)) | Visit 2 | 20.2 breaths per minute | Standard Deviation 2.9 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breaths Per Minute)) | Visit 3 | 20.0 breaths per minute | Standard Deviation 2.7 |
p-value: 0.13ANOVA
Secondary
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.
Time frame: For 8 weeks of the treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospekta | Percentage of Patients With Clinically Relevant Laboratory Abnormalities | 7 Participants |
| Placebo | Percentage of Patients With Clinically Relevant Laboratory Abnormalities | 3 Participants |
p-value: 0.2Fisher Exact
Other Pre-specified
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome.
Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD.
Time frame: For 8 weeks of the treatment
Population: A total of 66 AEs were identified in 46 patients, including 31 AEs in 23 patients in the Prospekta group, 35 AEs in 23 participants of Placebo group.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | Recovery/resolution | 25 Number of AE |
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | Recovery/resolution with consequences | 1 Number of AE |
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | No recovery/resolution | 3 Number of AE |
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | Outcome unknown | 2 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | Outcome unknown | 2 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | Recovery/resolution | 20 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | No recovery/resolution | 13 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome. | Recovery/resolution with consequences | 0 Number of AE |
p-value: 0.0254Fisher Exact
Other Pre-specified
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug.
Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD.
Time frame: For 8 weeks of the treatment
Population: A total of 66 AEs were identified in 46 patients, including 31 AEs in 23 patients in the Prospekta group, 35 AEs in 23 participants of Placebo group.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | No connection | 19 Number of AE |
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | Conditional | 3 Number of AE |
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | Can't be classified | 0 Number of AE |
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | Possible | 7 Number of AE |
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | Dubious | 2 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | Possible | 5 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | Dubious | 4 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | No connection | 19 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | Can't be classified | 3 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug. | Conditional | 4 Number of AE |
p-value: 0.5Fisher Exact
Other Pre-specified
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity.
Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD.
Time frame: For 8 weeks of the treatment
Population: Total number of AE was 66 among 46 participants. 31 AE in 23 participants of Prospekta group, 35 AE in 23 participants of Placebo group.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. | Light | 19 Number of AE |
| Prospekta | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. | Medium | 12 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. | Light | 19 Number of AE |
| Placebo | Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. | Medium | 16 Number of AE |
p-value: 0.62Fisher Exact