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

Phase 1

Withdrawn

• Conditions: Chronic Vegetative State
• Interventions: Dietary Supplement: RPh201; Dietary Supplement: saline

• Registration Number: NCT01417299
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Study Start: 2011-10
• Last Update Submitted: 2015-09-20
• Last Update Posted: 2015-09-22
• Primary Completion: 2017-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Chronic vegetative patients

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RPh201 group	RPh201	Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
placebo group	saline	Patients will receive 400 microliter s.c., of saline twice a week for 3 months

Primary Outcome Measures

Name	Time	Method
change in the awareness status of the patients.	3-6 months	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.

Secondary Outcome Measures

Name	Time	Method
change in the awareness status of the patients.	1 month following the end of the trial	clinical and fMRI assessment will be performed 1 month following treatment cessation