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

This study is not yet open for participant recruitment.
Verified August 2011 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01417299
First received: August 15, 2011
Last updated: April 16, 2012
Last verified: August 2011
History of Changes
  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: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Coma
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    clinical and fMRI assessment will be performed 1 month following treatment cessation


Estimated Enrollment: 10
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417299

Contacts
Contact: Arik Tzukert, DMD 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 972 2 6777572 lhadas@hadassah.org.il

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

No publications provided

Responsible Party: Dr. Netta Levin, Hadassah Medical Organization, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT01417299     History of Changes
Other Study ID Numbers: 0260-11-HMO
Study First Received: August 15, 2011
Last Updated: April 16, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013