NCT01438684SuspendedPhase 1
Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State
Hadassah Medical Organization1 site in 1 country10 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Suspended
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- consciousness level measured clinically
Study Overview
Brief Summary
The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state patients. The assessment will be done using clinical measurements and functional MRI studies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •chronic vegetative state patients
Exclusion Criteria
- •allergic reaction to treatment
- •patients that can not undergo MRI
- •Pregnancy
Arms & Interventions
RPh201 group
Active Comparator
7 patients will receive the treatment
Intervention: RPh201 (Drug)
non RPh201 group
Placebo Comparator
3 patients will receive placebo
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
consciousness level measured clinically
Time Frame: 6 months
Each patient will undergo a behavioral assessment (using the Coma Recovery Scale Revised) before treatment and every 2 weeks during the treatment period as well as 3 months following the end of the treatment. Complete blood counts, electrolytes, liver function tests, renal function tests and ECG will be performed every two weeks.
Secondary Outcomes
- Functional magnetic resonance imaging of cortical activity(6 months)
Investigators
Study Sites (1)
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