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. 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
Information provided by (Responsible Party):
Hadassah Medical Organization

September 21, 2011
September 22, 2011
February 6, 2018
September 2012
January 2019   (Final data collection date for primary outcome measure)
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.
consciousness level measured clinically and by functional MRI
Complete list of historical versions of study NCT01438684 on Archive Site
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
long lasting effects of the drug
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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.
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Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2020
January 2019   (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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
026011- HMO-CTIL
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Hadassah Medical Organization
Hadassah Medical Organization
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Hadassah Medical Organization
August 2017

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