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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 August 2015 by Netta Levin, Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438684
First Posted: September 22, 2011
Last Update Posted: September 1, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Netta Levin, Hadassah Medical Organization
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Netta Levin, Hadassah Medical Organization:

Primary Outcome Measures:
  • consciousness level measured clinically [ Time Frame: 6 months ]
    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 ]
    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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 state patients

Exclusion Criteria:

  • allergic reaction to treatment
  • patients that can not undergo MRI
  • 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): 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

Responsible Party: Netta Levin, Dr. Netta Levin, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01438684     History of Changes
Other Study ID Numbers: 026011- HMO-CTIL
First Submitted: September 21, 2011
First Posted: September 22, 2011
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Netta Levin, 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