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

NCT ID: NCT01417299

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Vegetative State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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RPh201 group

Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months

Group Type ACTIVE_COMPARATOR

RPh201

Intervention Type DIETARY_SUPPLEMENT

Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months

placebo group

Patients will receive 400 microliter s.c., of saline twice a week for 3 months

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DIETARY_SUPPLEMENT

Patients will receive 400 microliter s.c., of saline twice a week for 3 months

Interventions

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RPh201

Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months

Intervention Type DIETARY_SUPPLEMENT

saline

Patients will receive 400 microliter s.c., of saline twice a week for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Chronic vegetative patients

Exclusion Criteria

* Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization, Jerusalem, Israel

Principal Investigators

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Tamir Ben-Hur, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Other Identifiers

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0260-11-HMO

Identifier Type: -

Identifier Source: org_study_id

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