ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01438684
Recruitment Status : Suspended (due to lack of supply of medication and technical problems with the MRI)
First Posted : September 22, 2011
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Vegetative State Drug: RPh201 Drug: Saline Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : September 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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



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

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


Locations
Israel
Netta Levin
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01438684     History of Changes
Other Study ID Numbers: 026011- HMO-CTIL
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: August 2017

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