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Outcome Measures

Primary Outcomes (1)

The Average Change in the Total Score Across the "Inattention" and "Hyperactivity/Impulsivity" Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level.
The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder and oppositional defiant disorder symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores are calculated by summing the scores on the subset and dividing by the number of items in the subset. The main criterion for the treatment efficacy was the mean change in the total score on the "inattention" and "hyperactivity/impulsivity" subscales after 6 weeks of therapy. A conclusion of superiority of Mexidol over placebo can be made if the upper limit of the 95% confidence interval for the difference in mean changes is negative. 55 point scale: min value 0, max value 54, higher scores mean a worse outcome.
Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)

Secondary Outcomes (10)

Study Arms (3)

Main (Mexidol) + Control (Placebo)

OTHER

Participants received Mexidol 125 mg 1 tablet orally once a day and Mexidol Placebo matching Mexidol 125 mg 1 tablet orally once a day for 42 days.

Drug: Mexidol + Placebo

Main (Mexidol)

ACTIVE COMPARATOR

Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days.

Drug: Mexidol

Control (Placebo)

PLACEBO COMPARATOR

Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days.

Study Sites (14)

State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'

Yekaterinburg, Ural Region, 620075, Russia

Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian Federation

Kazan', 420012, Russia

State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital №1" of the Ministry of Health of the Krasnodar Territory

Krasnodar, 350007, Russia

Limited Liability Company "Center for Professional Therapy"

Krasnodar, 350051, Russia

Federal State Autonomous Educational Institution of Higher Education "Russian National Research Medical University named after N.I. Pirogov" Ministry of Health of the Russian Federation

Moscow, 117997, Russia

State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Center for Child Psychoneurology of the Moscow Department of Healthcare"

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAnxiety DisordersSpasmOppositional Defiant DisorderNeurodevelopmental DisordersImpulsive Behavior

Interventions

emoxypine succinate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersMental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Polina S. Nikiforova, MD

State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'

PRINCIPAL INVESTIGATOR

Nikolay N. Zavadenko, Dr.Med.Sci, Prof.

Federal State Autonomous Educational Institution of Higher Education "Russian National Research Medical University named after N.I. Pirogov" Ministry of Health of the Russian Federation

PRINCIPAL INVESTIGATOR

Olga V. Khaletskaya, Dr.Med.Sci, Prof.

Limited Liability Company "NizhMedClinic"

PRINCIPAL INVESTIGATOR

Elena V. Levitina, Dr.Med.Sci, Prof.

Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation,

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Multicenter, double-blind, randomized, placebo-controlled clinical trial in three parallel groups to evaluate efficacy and safety

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (3)

Main (Mexidol) + Control (Placebo)

Main (Mexidol)

Control (Placebo)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (3)

Main (Mexidol) + Control (Placebo)

Main (Mexidol)

Control (Placebo)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations