NCT01417299

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2011

Longer than P75 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 22, 2015

Status Verified

August 1, 2011

Enrollment Period

6 years

First QC Date

August 15, 2011

Last Update Submit

September 20, 2015

Conditions

Chronic Vegetative State

Keywords

chronic vegetative stateRPh201functional MRI

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • change in the awareness status of the patients.

    1 month following the end of the trial

Study Arms (2)

RPh201 group

ACTIVE COMPARATOR

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

Dietary Supplement: RPh201

placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: saline

Interventions

RPh201DIETARY_SUPPLEMENT

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

RPh201 group
salineDIETARY_SUPPLEMENT

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

placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic vegetative patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Persistent Vegetative State

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Tamir Ben-Hur, MD PhD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 16, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2017

Study Completion

October 1, 2018

Last Updated

September 22, 2015

Record last verified: 2011-08