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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Hadassah Medical Organization
Information provided by (Responsible Party):
Netta Levin, Hadassah Medical Organization Identifier:
First received: September 21, 2011
Last updated: August 30, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Chronic Vegetative State
Drug: RPh201
Drug: Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • consciousness level measured clinically [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RPh201 group
7 patients will receive the treatment
Drug: RPh201
400 microliter s.c. twice a week for 3 months
Placebo Comparator: non RPh201 group
3 patients will receive placebo
Drug: Saline
400 microliter Saline solution s.c. twice a week for 3 months


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • chronic vegetative state patients

Exclusion Criteria:

  • allergic reaction to treatment
  • patients that can not undergo MRI
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01438684

Contact: Arik Tzukert, DMD 00 972 2 6776095
Contact: Hadas Lemberg, PhD 00 972 2 6777572

Netta Levin Recruiting
Jerusalem, Israel
Contact: Netta Levin, Md Phd         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Netta Levin, Dr. Netta Levin, Hadassah Medical Organization Identifier: NCT01438684     History of Changes
Other Study ID Numbers: 026011- HMO-CTIL
Study First Received: September 21, 2011
Last Updated: August 30, 2015
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Persistent Vegetative State
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Unconsciousness processed this record on November 27, 2015