Recent Updates
Recently added Catalysts

BCI

Phase 2

Attention Deficit Hyperactivity Disorder | Unknown | Other |National Healthcare Corp.|Last Updated: Mar 30, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment192
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01344044Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)PHASE2 COMPLETED 192Jan 1, 2011May 13, 2016Mar 30, 20171 Singapore
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition
Week 0, 8, 20, 24
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BCI treatmentACTIVE_COMPARATORBCI treatment will commence during the week of the Baseline.
Wait-list controlOTHERBCI treatment will commence 8 weeks after Baseline
BCI pilot armEXPERIMENTALThis is a experimental arm to test out the safety and effectiveness of BCI in improving ADHD symptoms. This pilot arm is necessary as the BCI device, incorporating dry electrode sensors and intervention game, is newly developed and have not been tested out in children with ADHD. This preliminary study will also allow us to test out the treatment protocol (24 sessions of BCI training over 8 weeks) to see if it is efficacious.
Interventions
NameTypeDescription
BCIDEVICE24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
Unlock Study Design Details
Eligibility Criteria
Age Range6 Years — 12 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * DSM-IV-TR criteria for ADHD, either the combined or inattentive subtype, based on the Diagnostic Interview Schedule for Children (CDISC; Schaffer et al., 2000) Exclusion Criteria: * Present or history of medical treatment with stimulant medication and Atomoxetine * Co-morbid...

Countries:Singapore
Unlock Eligibility Criteria