Specific Developmental Disorders of Scholastic SkillsPhase 3NCT03159104
Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children
A Phase 3 study testing Tenoten for children in people with Specific Developmental Disorders of Scholastic Skills, run by Materia Medica Holding at 10 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Specific Developmental Disorders of Scholastic Skills
- What is being tested?
- Tenoten for children
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 10 sitesRussia
- Study dates
- 25 Aug 2015to 18 Feb 2019
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either gender aged 7 to 9 years old.
- School children of grades 1-3 (grade 1 children will be enrolled at the beginning of the second half of the year) in regular schools with state accreditation with principal educational program of elementary general education in compliance with Federal State Educational Standard of the Russian Federation.
- Beginning of the second half of the year (only for 1st grades).
- Specific developmental disorder of scholastic skills such as:
- specific reading disorder (F81.0);
- specific spelling disorder (F81.1);
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- specific disorder of arithmetical skills (F81.2);
- mixed disorder of scholastic skills (F81.3; i.e. meeting the criteria for one of the following combinations: F81.2+F81.0, F81.2+F81.1, or F81.2+F81.0+F81.1).
- Reading score of 15 to 35 on the Reading Skills test (L.A. Fotekova, T.V. Akhutina, 2002).
- Spelling score of 15 to 30 on the Spelling Skills test (L.A. Fotekova, T.V. Akhutina, 2002).
- Counting score of 5 to 15 on subtest No. 3 "Arithmetic" (of Wechsler Intelligence Scale for Children).
- Availability of a patient information sheet (Informed Consent form) signed by the parent/adopter to confirm the child's participation in the clinical trial.
Who cannot join
- History of the diseases:
- Diseases of the nervous system, including
- inflammatory diseases of the central nervous system;
- systemic atrophies;
- extrapyramidal and movement disorders;
- degenerative diseases of the nervous system;
Show all 40Show fewer
- demyelinating diseases of the central nervous system;
- episodic and paroxysmal disorders;
- polyneuropathies;
- diseases of myoneural junction and muscle;
- cerebral palsy.
- Congenital malformations of the nervous system (excl. Spina bifida without hydrocephalus)
- Diseases and congenital malformations of the eye causing impairment of vision.
- Diseases and congenital malformations of the ear causing impairment of hearing.
- Organic mental disorders.
- Mental retardation ranging from mild to profound.
- Stuttering (stammering).
- Obsessive-compulsive disorder.
- Pervasive developmental disorders including:
- childhood autism;
- atypical autism;
- Rett syndrome;
- overactive disorder associated with mental retardation and stereotyped movements;
- Asperger syndrome.
- Phakomatoses (tuberous sclerosis, neurofibromatosis).
- Postconcussional syndrome.
- Hereditary metabolic diseases, including glycogen storage disease (glycogenosis), disorders of galactose metabolism (galactosemia), other disorders of carbohydrate metabolism, disorders of glycosaminoglycan metabolism (mucopolysaccharidoses), disorders of aromatic amino-acid metabolism (phenylketonuria, tyrosinemia, etc.), disorders of branched-chain amino-acid metabolism and fatty-acid metabolism (maple-syrup-urine disease), mitochondrial myopathy.
- Chromosomal abnormalities.
- Administration of the products specified in section "Forbidden concomitant therapy" within the previous 4 weeks.
- Necessity in pharmacotherapy for underlying and/or concomitant disease during the following 12 weeks.
- Acute infectious disease or exacerbation/decompensation of a disease affecting the patient's ability to participate in the trial.
- Malignant neoplasm/suspected malignant neoplasm.
- Allergy/intolerance to any of the components of medications used in the treatment.
- Malabsorption syndrome including congenital or acquired lactase deficiency (or another disaccharidase deficiency), and galactosemia.
- Mental disorders of patient's parent(s)/adopter(s).
- Use of drugs or alcohol by the patient's parents/adopters at > 2 alcohol units a day (1 unit of alcohol is equivalent to 0.33 L of lager/150 mL of unfortified wine, or 40 mL of Ethyl Alcohol).
- Participation in other clinical trials in the previous 3 months.
- Patients whose parent(s)/adopter(s), from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the dose regimen of the investigational drug.
- Patients whose parent(s)/adopter(s) are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "Immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- Patients whose parent(s)/adopter(s) work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e., is the company's employee, temporary contract worker, or, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Russia10 sites
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Kazan', 420012
The State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital No. 1" of the Krasnodar Region Health Department
Krasnodar, 350007
Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation
Moscow, 117997
Moscow Regional Research and Clinical Institute ("MONIKI")
Moscow, 129110
Limited Liability Company "NIZHMEDCLINIKA"
Nizhny Novgorod, 603159
LLC City Neurological Center "Sibneyromed"
Novosibirsk, 630064
Municipal budgetary health care institution "Children's City Polyclinic № 4 of Rostov-on-Don"
Rostov-on-Don, 344065
St. Petersburg State Budgetary Institution of Health "Children's City Polyclinic № 35"
Saint Petersburg, 196191
Pediatric Research and Clinical Center for Infectious Diseases
Saint Petersburg, 197022
State Budgetary Healthcare Institution of Sverdlovsk Region Children's Clinical Hospital of Rehabilitation The Scientific and Practical Center "Bonum"
Yekaterinburg, 620149
About this study
Official title: 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
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.
Read the detailed description
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of the study treatment.
The study will enroll the school children (boys and girls) of grades 1, 2 and 3 of a regular school aged 7-9 years old (grade 1 school children will be enrolled at the beginning of the second half of the year) complaining of difficult learning classified according to ICD-10 as specific developmental disorders of scholastic skills (F81) including:
- specific reading disorder (F81.0);
- specific spelling disorder (F81.1);
- specific disorder of arithmetical skills (F81.2);
- mixed disorder of scholastic skills (F81.3);
- disorder simultaneously meeting criteria of F81.2+F81.0 or F81.2+F81.1, or F81.2+F81.0+F81.1.
The developmental disorders of scholastic skills will be verified by a doctor (either a neurologist or psychiatrist) according to reading, spelling, and counting tests. The children may have any concomitant diseases not considered as exclusion criteria and not requiring therapy during the following 12 weeks using the products specified in section "Forbidden concomitant therapy". Specific additional educational programs should not be performed within 12 weeks after enrollment either.
On signing information sheet (informed consent form) by the parent/adopter the patients will be examined by a neurologist or psychiatrist and tested for reading skills (method by L.A. Fotekova, Т.V. Akhutina, 2002;), spelling skills (method by L.A. Fotekova, Т.V. Akhutina, 2002) and counting skills (subtest No. 3 "Arithmetic" WISC test), and concomitant therapy will be recorded.
If inclusion criteria are met and non-inclusion criteria are absent at Visit 1, the patient will be enrolled in the trial and randomized into one of the two groups: 1 tablet of Tenoten for children three times daily for 3 months (group 1) or the same dosing regimen of Placebo (group 2).
At Visit 1 the parents/adopters will receive the study product for 12-week treatment period and a diary to report any potential adverse events and cases of concomitant therapy.
Six weeks later (Week 6±3 days) a "Phone visit" (Visit 2) will be made in order to interview parents about the patient's condition, the presence/absence of concomitant diseases, adverse events.
At Visit 3 (Week 12±3 days) repeated testing of reading, spelling and counting skills will be made, complaints, data on concomitant diseases, concomitant therapy, and adverse events will be collected. The investigator will evaluate the subject's compliance and fill in the Clinical Global Impression Scale to calculate Efficacy Index (CGI-EI).
The patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Forbidden concomitant therapy".
- Being tested
- Tenoten for children, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenoten for childrenDrug
Tablet for oral use.
PlaceboDrug
Tablet for oral use.
| Study group | Role | What they receive |
|---|---|---|
| Tenoten for children | Experimental | Dose per administration: 1 tablet. 1 tablet three times daily (3 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal. Receives: Drug: Tenoten for children |
| Placebo | Placebo comparator | Dose per administration: 1 tablet. 1 tablet three times daily (3 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).
The total scholastic skill score is calculated based on the points for reading, spelling, and counting skills.
Reading skills are estimated according to scale consisting of three subscales:reading speed, reading method/understanding, and reading accuracy. The minimum value of reading skills scale is 0 points, and the maximum value is 45 points.
Spelling skills are estimated according to scale in 0, 15, 30, and 45 points. The minimum value is 0 points, and the maximum value is 45 points.
Counting skills are estimated according to subtest No. 3 "Arithmetic" of "Wechsler Intelligence Scale for Children" (WISC) in points. The minimum value is 0 points, and the maximum value is 20 points.
Total scholastic skill score is a sum of three scales (reading, spelling, and counting). The minimum value is 0 points, and the maximum value is 110 points. A higher score means the best results.
Measured: On Day 1 and after 12 weeks of the therapy
Secondary outcomes (5)
Mean Reading Skills Score
Reading skills are estimated according to scale consisting of three subscales: reading speed, reading method/understanding, and reading accuracy.
Students of 7 years old are invited to read the words, and students of 8-9 years old are invited to read a small text. Speed, method, and accuracy of the reading are estimated in students of 7 years old. Speed, accuracy, and understanding of the text are estimated in students of 8-9 years old.
The minimum value is 0 points, and the maximum value is 45 points. A higher score meant the best results.
Measured: On Day 1 and after 12 weeks of the therapy
Mean Score Spelling Skills Score
Spelling skills are estimated according to scale in 0, 15, 30, and 45 points. Students of 7 years old are invited to write dictated letters, their names, and three words (mom, table, trunk), and students of 8-9 years old are invited to write a small dictation.
Dysgraphic errors and their types as well as the number of non-dysgraphic errors are taken into consideration for estimation.
The minimum value is 0 points, and the maximum value is 45 points. A higher score meant the best results.
Measured: On Day 1 and after 12 weeks of the therapy
Mean Counting Skills Score.
Counting skills are estimated according to subtest No. 3 "Arithmetic" of "Wechsler Intelligence Scale for Children" (WISC) in points. "Arithmetic" subtest includes 16 tasks from elementary school arithmetic which are tackled verbally. Easiness of operating numbers, accuracy, and time spent on the tasks are estimated. Each task is rated in points (0 or 1), by the end of testing and rating for each task the sum of points (raw score) is calculated and converted into a scale score using standard tables.
The minimum value is 0 points, and the maximum value is 20 points. A higher score meant the best results.
Measured: On Day 1 and after 12 weeks of the therapy
Percentage of Children With an Increase in Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).
Percentage of children with an increase in total scholastic skills score (a sum of three scales: reading, spelling, and counting).
Total scholastic skill score is a sum of three scales (reading, spelling, and counting).
The minimum value is 0 points, and the maximum value is 110 points. A higher score meant the best results. The increase in total scholastic skills score means an increasing by at least 5 points compared to baseline.
Measured: On Day 1 and after 12 weeks of the therapy
Efficacy Index According to Clinical Global Impression Scale.
The Clinical Global Impression-Efficiency Index (CGI-E) scale consists of two subscales.
Efficacy subscale measures efficacy of medicine based on the severity of symptoms at the end of therapy. The minimum value is 1 points, and the maximum value is 4 points. A higher score means the best results.
Side effects subscale measures side effects of the medicine. The minimum value is 1 points, and the maximum value is 4 points. A higher score means the best results.
The scale is filled in by the doctor at the final visit after 12 weeks of the treatment. In accordance with the results of treatment, the doctor expresses his opinion about the efficacy of the therapy and the degree of medicine safety, making marks in the appropriate columns of the table. The efficacy index is determined as intersection of columns of indicators of efficacy and side effects in the table. The minimum value is 0.25 points, and the maximum value is 4 points. A higher score means the best results.
Measured: In 12 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.
- First posted18 May 2017
- Study start25 Aug 2015
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Specific Developmental Disorders of Scholastic SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159104
- Sponsor's protocol ID
- MMH-TD-005
- Status last verified
- Oct 2021
- First submitted
- 17 May 2017
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03159104
- Acronym / sponsor ID
- MMH-TD-005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2015 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of the study treatment.
The study will enroll the school children (boys and girls) of grades 1, 2 and 3 of a regular school aged 7-9 years old (grade 1 school children will be enrolled at the beginning of the second half of the year) complaining of difficult learning classified according to ICD-10 as specific developmental disorders of scholastic skills (F81) including:
- specific reading disorder (F81.0);
- specific spelling disorder (F81.1);
- specific disorder of arithmetical skills (F81.2);
- mixed disorder of scholastic skills (F81.3);
- disorder simultaneously meeting criteria of F81.2+F81.0 or F81.2+F81.1, or F81.2+F81.0+F81.1.
The developmental disorders of scholastic skills will be verified by a doctor (either a neurologist or psychiatrist) according to reading, spelling, and counting tests. The children may have any concomitant diseases not considered as exclusion criteria and not requiring therapy during the following 12 weeks using the products specified in section "Forbidden concomitant therapy". Specific additional educational programs should not be performed within 12 weeks after enrollment either.
On signing information sheet (informed consent form) by the parent/adopter the patients will be examined by a neurologist or psychiatrist and tested for reading skills (method by L.A. Fotekova, Т.V. Akhutina, 2002;), spelling skills (method by L.A. Fotekova, Т.V. Akhutina, 2002) and counting skills (subtest No. 3 "Arithmetic" WISC test), and concomitant therapy will be recorded.
If inclusion criteria are met and non-inclusion criteria are absent at Visit 1, the patient will be enrolled in the trial and randomized into one of the two groups: 1 tablet of Tenoten for children three times daily for 3 months (group 1) or the same dosing regimen of Placebo (group 2).
At Visit 1 the parents/adopters will receive the study product for 12-week treatment period and a diary to report any potential adverse events and cases of concomitant therapy.
Six weeks later (Week 6±3 days) a "Phone visit" (Visit 2) will be made in order to interview parents about the patient's condition, the presence/absence of concomitant diseases, adverse events.
At Visit 3 (Week 12±3 days) repeated testing of reading, spelling and counting skills will be made, complaints, data on concomitant diseases, concomitant therapy, and adverse events will be collected. The investigator will evaluate the subject's compliance and fill in the Clinical Global Impression Scale to calculate Efficacy Index (CGI-EI).
The patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Forbidden concomitant therapy".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenoten for children | Experimental | Drug: Tenoten for childrenDose per administration: 1 tablet. 1 tablet three times daily (3 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal. |
| Placebo | Placebo comparator | Drug: PlaceboDose per administration: 1 tablet. 1 tablet three times daily (3 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Children of either gender aged 7 to 9 years old.
- School children of grades 1-3 (grade 1 children will be enrolled at the beginning of the second half of the year) in regular schools with state accreditation with principal educational program of elementary general education in compliance with Federal State Educational Standard of the Russian Federation.
- Beginning of the second half of the year (only for 1st grades).
- Specific developmental disorder of scholastic skills such as:
- Reading score of 15 to 35 on the Reading Skills test (L.A. Fotekova, T.V. Akhutina, 2002).
Key exclusion criteria (40 listed)
- History of the diseases:
- Administration of the products specified in section "Forbidden concomitant therapy" within the previous 4 weeks.
- Necessity in pharmacotherapy for underlying and/or concomitant disease during the following 12 weeks.
- Acute infectious disease or exacerbation/decompensation of a disease affecting the patient's ability to participate in the trial.
- Malignant neoplasm/suspected malignant neoplasm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenoten for childrenTablet for oral use. | Drug | Tenoten for children |
| PlaceboTablet for oral use. | Drug | Placebo |
Primary outcome
Mean Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).
Time frame: On Day 1 and after 12 weeks of the therapy
The total scholastic skill score is calculated based on the points for reading, spelling, and counting skills. Reading skills are estimated according to scale consisting of three subscales:reading speed, reading method/understanding, and reading accuracy. The minimum value of reading skills scale is 0 points, and the maximum value is 45 points. Spelling skills are estimated according to scale in 0, 15, 30, and 45 points. The minimum value is 0 points, and the maximum value is 45 points. Counting skills are estimated according to subtest No. 3 "Arithmetic" of "Wechsler Intelligence Scale for Children" (WISC) in points. The minimum value is 0 points, and the maximum value is 20 points. Total scholastic skill score is a sum of three scales (reading, spelling, and counting). The minimum value is 0 points, and the maximum value is 110 points. A higher score means the best results.
5 secondary outcomes
Mean Reading Skills Score
Time frame: On Day 1 and after 12 weeks of the therapy
Mean Score Spelling Skills Score
Time frame: On Day 1 and after 12 weeks of the therapy
Mean Counting Skills Score.
Time frame: On Day 1 and after 12 weeks of the therapy
Percentage of Children With an Increase in Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).
Time frame: On Day 1 and after 12 weeks of the therapy
Efficacy Index According to Clinical Global Impression Scale.
Time frame: In 12 weeks of the treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenoten for children in people with Specific Developmental Disorders of Scholastic Skills, run by Materia Medica Holding at 10 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 12 inclusion and 40 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 21 Aug 2023). 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?
Mean Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting). (time frame: On Day 1 and after 12 weeks of the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.