Motor ActivityNCT02655276
Sublingual Glycine vs. Placebo on Attentional Difficulties and Hyperactivity in Prepuberal Children
A study testing microencapsulated Glycine in people with Motor Activity and Attention Deficit, run by Eberhard Schulz at 1 site in Germany.
Trial summary
This study is designed to investigate effects on attentional performance and motoric activity of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Attention Deficit, Stress, Psychological
- What is being tested?
- microencapsulated Glycine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who meet all of the following inclusion criteria will be eligible for enrollment in the study:
- Male and female subjects aged 6-14 years with Tanner stages 0 to 3 and attentional and/or hyperactivity problems.
- Subjects with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, assent to participate must be obtained from all children entering the study if the child is able to judge the nature, the meaning and the significance of the trial. Assent will be documented by the child´s signature on the consent form.
- Health Status: Subjects must not have clinically significant diseases or clinically significant abnormal laboratory values as assessed during medical history and physical exam.
- Subjects meeting minimum intelligence requirements: In the opinion of the investigator the subject must generally be functioning at age-appropriate levels academically, which should take into account any prior cognitive or academic testing (basic knowledge of reading, writing and calculating).
- Subject has an ADHD-RS-IV total score ≥18.
- Subjects already receiving behavioral therapies for HKS/ADHD or oppositional defiant disorder may continue to do sor during the course of the trial.
Who cannot join
- subjects with psychiatric disorders requiring current pharmacological treatment (e.g. major depression, psychosis)
- Subjects with psychiatric or somatic conditions that may contraindicate the trial or confound efficacy or safety assessments.
- Subjects with a history of drug abuse or current use of recreational drugs.
- History of hypersensitivity to microencapsulated Glycine or placebo.
- Subjects who are judged by the investigator as likely to be non-compliant with study procedures.
- Use of any investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital
Freiburg im Breisgau, Baden-Wurttemberg, 79104
About this study
Official title: Effects of Sublingual Microencapsulated Glycine on Attentional Difficulties and Hyperactivity in Prepuberal Children - A Placebo-controlled, Double-blind, Randomized, Cross-over Study
This study is designed to investigate effects on attentional performance and motoric activity of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each.
The primary objective of the study is to determine the effects on attentional performance and motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with low attentional performance and high motoric activity.
A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance and high motoric activity will be enrolled in this study. The prepuberal status will be determined by Tanner stages ≤ 3.
Read the detailed description
Trial Design:
This study has a double-blind, randomized, two-period, cross-over design. The study population will be randomized equally to the sequence 1 (first 3 weeks microencapsulated Glycine, second 3 weeks placebo) or sequence 2 (first 3 weeks placebo, second 3 weeks microencapsulated Glycine). Study Agent/Placebo - Dosage and Route of Administration:
Study Agent/Placebo will first be dispensed at Visit 2 (day 0). Treatment assignments will be made in accordance with the randomization. At each visit (Visit 2 and Visit 3), subjects will receive two blisters for the 3 following weeks. Only qualified personnel may dispense study Agent/Placebo.
Investigational and reference treatment:
100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) Placebo from Biotiki®
Study design:
This study will employ a double blind, randomized, placebo-controlled cross-over design. SKAMP raters and teachers will be blinded concerning the study Agent/Placebo.
Planned Study Time Schedule:
The study ends 10 weeks after enrollment of the last patient (total study end). Study duration for each patient is between 7 and 10 weeks (from inclusion) until the last visit (close-out visit).
Statistics:
Sample size calculation is based on the primary endpoint "mean of the SKAMP Combined score over all time points in the classroom setting". The study should have sufficient power to detect a difference between treatments if a moderate effect size (corresponding to Cohen's d=0.5) were present in parallel-group study in two independent patient groups. Assuming a correlation between measurements in the same patient of 0.6, this translates into an effect size of 0.56 in a cross-over trial comparing within patient measurements. With this effect size, 27 patients have to be included in the study, to achieve a power of 0.8 at a two-sided significance level of alpha=0.05. To account for a small number of drop-outs, 30 patients have to be randomized.
Data analysis: The trial will be analyzed according to the intention-to-treat principle. Efficacy measures will be evaluated by linear mixed models for repeated measurements.
Safety analyses will be performed for subjects who received at least one dose of microencapsulated Glycine/ placebo. Incidences of adverse events and of serious adverse events will be calculated.
- Conditions
- Motor Activity, Attention Deficit, Stress, Psychological
- Being tested
- microencapsulated Glycine, Placebo tablets
- Keywords
- microencapsulated glycine, attentional performance, motoric activity, hyperactivity
- Medical subject headings
- Motor Activity, Attention Deficit Disorder with Hyperactivity, Stress, Psychological, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microencapsulated GlycineOther
100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d.
Placebo tabletsOther
Placebo t.i.d. from Biotiki® in a crossover-design.
| Study group | Role | What they receive |
|---|---|---|
| 100 mg microencapsulated Glycine and then Placebo tablets | Experimental | 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the first three weeks and then Placebo t.i.d. from Biotiki® for the second three weeks. Receives: Other: microencapsulated Glycine; Other: Placebo tablets |
| Placebo tablets and then 100 mg microencapsulated Glycine | Experimental | Placebo t.i.d. from Biotiki® for the first three weeks and then 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the second three weeks. Receives: Other: microencapsulated Glycine; Other: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
SKAMP-Combined rating scale in the classroom setting
SKAMP-Combined rating performed at 25 minutes before and 0:50 h, 1,55 h, 2:50 h, 4:05 h, 5:50 h, 7:40 h and 8:35 h after first microencapsulated Glycine/ placebo intake in a laboratory classroom setting after a 3 week treatment period. The primary efficacy endpoint is the mean of the SKAMP-Combined score over all time points in the classroom setting.
Measured: 3 weeks
Secondary outcomes (8)
SKAMP-Attention subscale
SKAMP- Attention subscale rating performed at 25 minutes before and 0:50 h, 1,55 h, 2:50 h, 4:05 h, 5:50 h, 7:40 h and 8:35 h after first microencapsulated Glycine/ placebo intake in a laboratory classroom setting after a 3 week treatment period. The secondary efficacy endpoint is the mean of the SKAMP- Attention subscale score over all time points in the classroom setting.
Measured: 3 weeks
SKAMP-Deportment subscale
SKAMP- Deportment subscale rating performed at 25 minutes before and 0:50 h, 1,55 h, 2:50 h, 4:05 h, 5:50 h, 7:40 h and 8:35 h after first microencapsulated Glycine/ placebo intake in a laboratory classroom setting after a 3 week treatment period. The secondary efficacy endpoint is the mean of the SKAMP- Deportment subscale score over all time points in the classroom setting.
Measured: 3 weeks
Child Behaviour Checklist (CBCL)
The assessment of the child behaviour scale (CBCL) is performed by the primary caregivers due to the last week before the visit of a classroom. The CBCL global score and the CBCL subscores are used for evaluation.
Measured: 3 weeks
Quality of life scores
The instrument provides a QoL total score and several domains of QoL regarding family, school, peers, interests, physical and mental health, and also the impact of the respective disorder. These scores are used for evaluation.
Measured: 3 weeks
Visual-Analogue-Scale of perceived parental stress
The value of the visual-analogue-scale of perceived parental stress is used for evaluation.
Measured: 3 weeks
Saliva cortisol levels
In this study, saliva cortisol samples are collected for determination of the cortisol awakening response (CAR) as well as before and after the supposedly stressful situation of the classroom math test. For the CAR, cortisol will be measured on three consecutive days before Visit 2, 3 and 4 at awakening, 30 minutes after awakening and before bedtime.
For assessment of cortisol levels under acute stress, cortisol samples will be taken before and after classroom III of Visit 2, as well as before and after classroom III and VI of Visits 3 and 4.
Measured: 3 weeks
ADHD-Rating scale-IV
The ADHD Rating Scale-IV is a reliable and easy-to-administer instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. Containing 18 items, the scale is linked directly to DSM-IV diagnostic criteria for ADHD.
Outcome Measure are the summed total score for "Inattention, Hyperactivity and Impulsivity" and the sub-scores for "Inattention" and for "Hyperactivity and Impulsivity".
Measured: 3 weeks
Adverse Events that are related or not related to treatment
All adverse events no matter how intense will be observed by the investigator until resolved or until they can be sufficiently medical explained. All AEs must be described by diagnosis or symptoms, duration, frequency, severity, an assessment of its cause, its relationship to the study Glycine or placebo, whether it influenced the course of the study Glycine or placebo, whether it required specific therapy and its outcome.
All documented AEs will be evaluated.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eberhard Schulz
- Sponsor type
- University, hospital or other
- Collaborators
- Biotiki
- Responsible party
- Sponsor-investigator, Eberhard Schulz, University Hospital Freiburg
- Investigators
- Eberhard Schulz, Prof. Dr., Study director, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655276
- Sponsor's protocol ID
- Classroom FR03
- Status last verified
- Dec 2017
- First submitted
- 8 Jan 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sublingual Microencapsulated Glycine on Attentional Difficulties and Hyperactivity in Prepuberal Children - A Placebo-controlled, Double-blind, Randomized, Cross-over Study
- ClinicalTrials.gov ID
- NCT02655276
- Acronym / sponsor ID
- Classroom FR03
- Conditions
- Motor Activity, Attention Deficit, Stress, Psychological
- Keywords
- microencapsulated glycine, attentional performance, motoric activity, hyperactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eberhard SchulzUniversity, hospital or other
- Collaborators
- Biotiki
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate effects on attentional performance and motoric activity of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each.
The primary objective of the study is to determine the effects on attentional performance and motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with low attentional performance and high motoric activity.
A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance and high motoric activity will be enrolled in this study. The prepuberal status will be determined by Tanner stages ≤ 3.
Detailed description
Trial Design:
This study has a double-blind, randomized, two-period, cross-over design. The study population will be randomized equally to the sequence 1 (first 3 weeks microencapsulated Glycine, second 3 weeks placebo) or sequence 2 (first 3 weeks placebo, second 3 weeks microencapsulated Glycine). Study Agent/Placebo - Dosage and Route of Administration:
Study Agent/Placebo will first be dispensed at Visit 2 (day 0). Treatment assignments will be made in accordance with the randomization. At each visit (Visit 2 and Visit 3), subjects will receive two blisters for the 3 following weeks. Only qualified personnel may dispense study Agent/Placebo.
Investigational and reference treatment:
100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) Placebo from Biotiki®
Study design:
This study will employ a double blind, randomized, placebo-controlled cross-over design. SKAMP raters and teachers will be blinded concerning the study Agent/Placebo.
Planned Study Time Schedule:
The study ends 10 weeks after enrollment of the last patient (total study end). Study duration for each patient is between 7 and 10 weeks (from inclusion) until the last visit (close-out visit).
Statistics:
Sample size calculation is based on the primary endpoint "mean of the SKAMP Combined score over all time points in the classroom setting". The study should have sufficient power to detect a difference between treatments if a moderate effect size (corresponding to Cohen's d=0.5) were present in parallel-group study in two independent patient groups. Assuming a correlation between measurements in the same patient of 0.6, this translates into an effect size of 0.56 in a cross-over trial comparing within patient measurements. With this effect size, 27 patients have to be included in the study, to achieve a power of 0.8 at a two-sided significance level of alpha=0.05. To account for a small number of drop-outs, 30 patients have to be randomized.
Data analysis: The trial will be analyzed according to the intention-to-treat principle. Efficacy measures will be evaluated by linear mixed models for repeated measurements.
Safety analyses will be performed for subjects who received at least one dose of microencapsulated Glycine/ placebo. Incidences of adverse events and of serious adverse events will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 mg microencapsulated Glycine and then Placebo tablets | Experimental | Other: microencapsulated Glycine, Other: Placebo tablets100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the first three weeks and then Placebo t.i.d. from Biotiki® for the second three weeks. |
| Placebo tablets and then 100 mg microencapsulated Glycine | Experimental | Other: microencapsulated Glycine, Other: Placebo tabletsPlacebo t.i.d. from Biotiki® for the first three weeks and then 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the second three weeks. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects who meet all of the following inclusion criteria will be eligible for enrollment in the study:
- Male and female subjects aged 6-14 years with Tanner stages 0 to 3 and attentional and/or hyperactivity problems.
- Subjects with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, assent to participate must be obtained from all children entering the study if the child is able to judge the nature, the meaning and the significance of the trial. Assent will be documented by the child´s signature on the consent form.
- Health Status: Subjects must not have clinically significant diseases or clinically significant abnormal laboratory values as assessed during medical history and physical exam.
- Subjects meeting minimum intelligence requirements: In the opinion of the investigator the subject must generally be functioning at age-appropriate levels academically, which should take into account any prior cognitive or academic testing (basic knowledge of reading, writing and calculating).
Key exclusion criteria (7 listed)
- subjects with psychiatric disorders requiring current pharmacological treatment (e.g. major depression, psychosis)
- Subjects with psychiatric or somatic conditions that may contraindicate the trial or confound efficacy or safety assessments.
- Subjects with a history of drug abuse or current use of recreational drugs.
- History of hypersensitivity to microencapsulated Glycine or placebo.
- Subjects who are judged by the investigator as likely to be non-compliant with study procedures.
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 |
|---|---|---|
| microencapsulated Glycine100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. | Other | 100 mg microencapsulated Glycine and then Placebo tablets, Placebo tablets and then 100 mg microencapsulated Glycine |
| Placebo tabletsPlacebo t.i.d. from Biotiki® in a crossover-design. | Other | 100 mg microencapsulated Glycine and then Placebo tablets, Placebo tablets and then 100 mg microencapsulated Glycine |
Primary outcome
SKAMP-Combined rating scale in the classroom setting
Time frame: 3 weeks
SKAMP-Combined rating performed at 25 minutes before and 0:50 h, 1,55 h, 2:50 h, 4:05 h, 5:50 h, 7:40 h and 8:35 h after first microencapsulated Glycine/ placebo intake in a laboratory classroom setting after a 3 week treatment period. The primary efficacy endpoint is the mean of the SKAMP-Combined score over all time points in the classroom setting.
8 secondary outcomes
SKAMP-Attention subscale
Time frame: 3 weeks
SKAMP-Deportment subscale
Time frame: 3 weeks
Child Behaviour Checklist (CBCL)
Time frame: 3 weeks
Quality of life scores
Time frame: 3 weeks
Visual-Analogue-Scale of perceived parental stress
Time frame: 3 weeks
Saliva cortisol levels
Time frame: 3 weeks
ADHD-Rating scale-IV
Time frame: 3 weeks
Adverse Events that are related or not related to treatment
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Motor Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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.
Eberhard Schulz, Prof. Dr. study director
University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microencapsulated Glycine in people with Motor Activity and Attention Deficit, run by Eberhard Schulz at 1 site in Germany.
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 7 inclusion and 7 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SKAMP-Combined rating scale in the classroom setting (time frame: 3 weeks). 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 6 Dec 2017.