NCT02655276

Sublingual Glycine vs. Placebo on Attentional Difficulties and Hyperactivity in Prepuberal Children

Effects of Sublingual Microencapsulated Glycine on Attentional Difficulties and Hyperactivity in Prepuberal Children - A Placebo-controlled, Double-blind, Randomized, Cross-over Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Eberhard Schulz · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Motor Activity
• Attention Deficit
• Stress, Psychological

Interventions

Type	Name	Description
OTHER	microencapsulated Glycine	100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d.
OTHER	Placebo tablets	Placebo t.i.d. from Biotiki® in a crossover-design.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-01-14
• Last updated: 2017-12-06

Locations

1 site across 1 country: Germany