CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
Tenoten for children +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Children aged 7 to 9 years old, either gender
  • ✓Enrolled in grades 1-3 of accredited regular schools (grade 1 students enrolled only after second half of year begins)
  • ✓Documented specific developmental disorder of scholastic skills: reading disorder (F81.0), spelling disorder (F81.1), arithmetic disorder (F81.2), or mixed scholastic disorder (F81.3)
  • ✓Reading score 15-35 on Reading Skills test (L.A. Fotekova, T.V. Akhutina, 2002)
Key exclusion· 10
  • ✕History of nervous system diseases: inflammatory CNS diseases, atrophies, extrapyramidal disorders, degenerative diseases, demyelinating diseases, seizure disorders, polyneuropathies, myoneural junction/muscle diseases, or cerebral palsy
  • ✕Congenital nervous system malformations (except spina bifida without hydrocephalus)
  • ✕Eye or ear disease/malformation causing vision or hearing impairment
  • ✕Mental retardation (mild to profound), organic mental disorders, or pervasive developmental disorders (autism, Rett syndrome, Asperger syndrome)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03159104
NCT03159104Phase 3Completed
CompareCT.gov

Multicenter Double-blind Placebo-Controlled Randomized Clinical Trial of Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children

Materia Medica Holding·interventional·Posted May 18, 2017·Updated Aug 21, 2023

In Brief

A Phase 3 clinical trial evaluating Tenoten for children and Placebo for Specific Developmental Disorders of Scholastic Skills. Completed, enrolled 240 participants across 10 sites.

Detailed Summary

Purpose of the study: • To evaluate efficacy and safety of Tenoten for children in the treatment of specific developmental disorders of scholastic skills in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpecific Developmental Disorders of Scholastic Skills
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 18, 2017
Enrollment StartAug 25, 2015
Primary CompletionFeb 18, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.1 years ago

Interventions

Tenoten for childrendrug

Tablet for oral use.

Placebodrug

Tablet for oral use.