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

Chronic Vegetative State Clinical Trial

— RPh-in-CVS  

Official title:

Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01438684
• Other study ID #: 026011- HMO-CTIL
• Status: Suspended
• Phase: Phase 1
• First received: September 21, 2011
• Last updated: February 4, 2018
• Start date: September 2012
• Est. completion date: October 2020

Study information

• Verified date: August 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: October 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• chronic vegetative state patients

Exclusion Criteria:

• allergic reaction to treatment

• patients that can not undergo MRI

• Pregnancy

Related Conditions & MeSH terms

• Chronic Vegetative State
• Persistent Vegetative State

Intervention

Drug:
• RPh201
400 microliter s.c. twice a week for 3 months
• Saline
400 microliter Saline solution s.c. twice a week for 3 months

Locations

Country	Name	City	State
Israel	Netta Levin	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consciousness level measured clinically	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.	6 months
Secondary	Functional magnetic resonance imaging of cortical activity	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	6 months