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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Withdrawn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
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, RPh201, functional MRI

Eligibility Criteria

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

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

    First Posted
    August 15, 2011
    Last Updated
    September 20, 2015
    Sponsor
    Hadassah Medical Organization
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    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    Withdrawn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

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