The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements

Chronic Vegetative State Clinical Trial

— CVS  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01417299
• Other study ID #: 0260-11-HMO
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 15, 2011
• Last updated: September 20, 2015
• Start date: October 2011
• Est. completion date: October 2018

Study information

• Verified date: August 2011
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Chronic vegetative patients

Exclusion Criteria:

• Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Vegetative State
• Persistent Vegetative State

Intervention

Dietary Supplement:
• RPh201
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
• saline
Patients will receive 400 microliter s.c., of saline twice a week for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the awareness status of the patients.	Clinical and laboratory assessment will be done every two weeks along the treatment period fMRI assessment will be performed 3 times: before the treatment, immediate afterwards and one month following treatment cessation.	3-6 months	Yes
Secondary	change in the awareness status of the patients.	clinical and fMRI assessment will be performed 1 month following treatment cessation	1 month following the end of the trial	Yes