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

Primary Purpose

Chronic Vegetative State

Status
Suspended
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
RPh201
Saline
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Vegetative State focused on measuring chronic vegetative state, functional MRI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic vegetative state patients

Exclusion Criteria:

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

Sites / Locations

  • Netta Levin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RPh201 group

non RPh201 group

Arm Description

7 patients will receive the treatment

3 patients will receive placebo

Outcomes

Primary Outcome Measures

consciousness level measured clinically
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

Functional magnetic resonance imaging of cortical activity
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

Full Information

First Posted
September 21, 2011
Last Updated
February 4, 2018
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01438684
Brief Title
The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study
Acronym
RPh-in-CVS
Official Title
Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Suspended
Why Stopped
due to lack of supply of medication and technical problems with the MRI
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Vegetative State
Keywords
chronic vegetative state, functional MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RPh201 group
Arm Type
Active Comparator
Arm Description
7 patients will receive the treatment
Arm Title
non RPh201 group
Arm Type
Placebo Comparator
Arm Description
3 patients will receive placebo
Intervention Type
Drug
Intervention Name(s)
RPh201
Intervention Description
400 microliter s.c. twice a week for 3 months
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
400 microliter Saline solution s.c. twice a week for 3 months
Primary Outcome Measure Information:
Title
consciousness level measured clinically
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional magnetic resonance imaging of cortical activity
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic vegetative state patients Exclusion Criteria: allergic reaction to treatment patients that can not undergo MRI Pregnancy
Facility Information:
Facility Name
Netta Levin
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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

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