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

This study is currently recruiting participants.
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Netta Levin, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01438684
First received: September 21, 2011
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Coma
U.S. FDA Resources

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 2014
Estimated Primary Completion Date: January 2014 (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

  Eligibility

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

Inclusion Criteria:

  • chronic vegetative state patients

Exclusion Criteria:

  • allergic reaction to treatment
  • patients that can not undergo MRI
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438684

Contacts
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
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
ClinicalTrials.gov Identifier: NCT01438684     History of Changes
Other Study ID Numbers: 026011- HMO-CTIL
Study First Received: September 21, 2011
Last Updated: March 20, 2013
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
Nervous System Diseases
 Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013