A Phase IB, Double-blind, Randomized, Placebo-Controlled, Parallel Group Study of the Safety, Tolerability, Preliminary Efficacy and Pharmacodynamics of BTD-001 in Young Adults and Adolescents with Down Syndrome

ovotech (Australia) Pty Limited0 个研究点目标入组 90 人开始时间: 2012年6月19日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Males and females, age 13–35 years with Down syndrome 2. Body weight greater than 40 kg AND BMI less than 40.0 kg/m2 3. Ability to cooperate and complete required tests and procedures. 4. Capable of undergoing the cognitive test battery and evoked response potential testing. 5. Negative pregnancy test AND non-lactating (females only) 6. If sexually active and female, the person with DS must be surgically sterile OR using reliable contraception 7. Laboratory findings, vital signs and ECG within normal limits or any abnormalities judged clinically not significant 8. Stable medical condition For Parents/Guardians 1. Parents or guardians of the person with DS must understand the study, give written and dated informed consent/assent, and successfully complete behavioural assessment interviews. 2. Parent or guardian agree to accompany the subject to all visits, be capable of supervising and reporting study drug use and adequately reporting the subject’s functional status.

•1. Current use of anti-epileptics, focal seizure disorder, syncope, unexplained loss of consciousness at any time OR seizure in the past 3 years.
•2. History of or concurrent neurological disorders interfering with cognition.
•3. History or diagnosis of clinically significant psychiatric or neurological disease.
•4. Neuroleptic agent, bilobalide-containing product OR benzodiazepine use in last 4 weeks
•5. Significant endocrine abnormality
•6. Subjects with hypothyroidism are excluded unless they have received a stable dose of medication.
•7. Significant hepatic impairment
•8. Significant renal impairment
•9. History of porphyria
•10. History of leukemia or other malignancy
•11. Participation in a clinical drug trial within 4 weeks
•12. Severe sleep apnea or excess daytime sleepiness
•13. Recent or anticipated use of prohibited medications
•14. Have any other condition which, in the Investigator’s opinion, would put the person with Down syndrome at risk by participating in this study

发起方

ovotech (Australia) Pty Limited