The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study

Phase 1

Suspended

• Conditions: Chronic Vegetative State
• Interventions: Drug: RPh201; Drug: Saline

• Registration Number: NCT01438684
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Study Start: 2012-09
• Status Verified: 2017-08
• Last Update Submitted: 2018-02-04
• Last Update Posted: 2018-02-06
• Primary Completion: 2019-01
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• chronic vegetative state patients

Exclusion Criteria

• allergic reaction to treatment
• patients that can not undergo MRI
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RPh201 group	RPh201	7 patients will receive the treatment
non RPh201 group	Saline	3 patients will receive placebo

Primary Outcome Measures

Name	Time	Method
consciousness level measured clinically	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 Outcome Measures

Name	Time	Method
Functional magnetic resonance imaging of cortical activity	6 months	3 scans will be performed: before treatment, after three months of treatment and 3 months after cessation of treatment. Scanning sessions will include a hierarchical auditory paradigm, an imagery task and resting state fMRI

Trial Locations

Locations (1)

Netta Levin; 🇮🇱 Jerusalem, Israel