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
Sponsor:
Information provided by (Responsible Party):
Netta Levin, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01438684
First received: September 21, 2011
Last updated: August 30, 2015
Last verified: August 2015

September 21, 2011
August 30, 2015
September 2012
January 2017   (final data collection date for primary outcome measure)
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.
consciousness level measured clinically and by functional MRI
Complete list of historical versions of study NCT01438684 on ClinicalTrials.gov Archive Site
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
long lasting effects of the drug
Not Provided
Not Provided
 
The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study
Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Vegetative State
  • Drug: RPh201
    400 microliter s.c. twice a week for 3 months
  • Drug: Saline
    400 microliter Saline solution s.c. twice a week for 3 months
  • Active Comparator: RPh201 group
    7 patients will receive the treatment
    Intervention: Drug: RPh201
  • Placebo Comparator: non RPh201 group
    3 patients will receive placebo
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
October 2018
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • chronic vegetative state patients

Exclusion Criteria:

  • allergic reaction to treatment
  • patients that can not undergo MRI
  • Pregnancy
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Israel
 
NCT01438684
026011- HMO-CTIL
Not Provided
Not Provided
Not Provided
Netta Levin, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP