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The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements (CVS)

This study has been withdrawn prior to enrollment.
(This record is an additional copy of the study listed above)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417299
First Posted: August 16, 2011
Last Update Posted: September 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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.

Condition Intervention Phase
Chronic Vegetative State Dietary Supplement: RPh201 Dietary Supplement: saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • change in the awareness status of the patients. [ Time Frame: 3-6 months ]
    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. [ Time Frame: 1 month following the end of the trial ]
    clinical and fMRI assessment will be performed 1 month following treatment cessation


Enrollment: 0
Study Start Date: October 2011
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RPh201 group
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
Dietary Supplement: RPh201
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
Placebo Comparator: placebo group
Patients will receive 400 microliter s.c., of saline twice a week for 3 months
Dietary Supplement: saline
Patients will receive 400 microliter s.c., of saline twice a week for 3 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic vegetative patients

Exclusion Criteria:

  • Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417299


Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Tamir Ben-Hur, MD PhD Hadassah Medical Organization
  More Information

Responsible Party: Dr. Netta Levin, Hadassah Medical Organization, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT01417299     History of Changes
Other Study ID Numbers: 0260-11-HMO
First Submitted: August 15, 2011
First Posted: August 16, 2011
Last Update Posted: September 22, 2015
Last Verified: August 2011

Keywords provided by Hadassah Medical Organization:
chronic vegetative state
RPh201
functional MRI

Additional relevant MeSH terms:
Persistent Vegetative State
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms