The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements (CVS)
Primary Purpose
Chronic Vegetative State
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
RPh201
saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Vegetative State focused on measuring chronic vegetative state, RPh201, functional MRI
Eligibility Criteria
Inclusion Criteria:
- Chronic vegetative patients
Exclusion Criteria:
- Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
RPh201 group
placebo group
Arm Description
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
Patients will receive 400 microliter s.c., of saline twice a week for 3 months
Outcomes
Primary Outcome Measures
change in the awareness status of the patients.
Clinical and laboratory assessment will be done every two weeks along the treatment period fMRI assessment will be performed 3 times: before the treatment, immediate afterwards and one month following treatment cessation.
Secondary Outcome Measures
change in the awareness status of the patients.
clinical and fMRI assessment will be performed 1 month following treatment cessation
Full Information
NCT ID
NCT01417299
First Posted
August 15, 2011
Last Updated
September 20, 2015
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01417299
Brief Title
The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements
Acronym
CVS
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
This record is an additional copy of the study listed above
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI 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, RPh201, functional MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RPh201 group
Arm Type
Active Comparator
Arm Description
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Patients will receive 400 microliter s.c., of saline twice a week for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
RPh201
Intervention Description
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
saline
Intervention Description
Patients will receive 400 microliter s.c., of saline twice a week for 3 months
Primary Outcome Measure Information:
Title
change in the awareness status of the patients.
Description
Clinical and laboratory assessment will be done every two weeks along the treatment period fMRI assessment will be performed 3 times: before the treatment, immediate afterwards and one month following treatment cessation.
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
change in the awareness status of the patients.
Description
clinical and fMRI assessment will be performed 1 month following treatment cessation
Time Frame
1 month following the end of the trial
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 patients
Exclusion Criteria:
Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamir Ben-Hur, MD PhD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements
We'll reach out to this number within 24 hrs