NCT01438684

Brief 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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

February 6, 2018

Status Verified

August 1, 2017

Enrollment Period

6.3 years

First QC Date

September 21, 2011

Last Update Submit

February 4, 2018

Conditions

Chronic Vegetative State

Keywords

chronic vegetative statefunctional MRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Functional magnetic resonance imaging of cortical activity

    6 months

Study Arms (2)

RPh201 group

ACTIVE COMPARATOR

7 patients will receive the treatment

Drug: RPh201

non RPh201 group

PLACEBO COMPARATOR

3 patients will receive placebo

Drug: Saline

Interventions

RPh201DRUG

400 microliter s.c. twice a week for 3 months

RPh201 group
SalineDRUG

400 microliter Saline solution s.c. twice a week for 3 months

non RPh201 group

Eligibility Criteria

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

You may qualify if:

  • chronic vegetative state patients

You may not qualify if:

  • allergic reaction to treatment
  • patients that can not undergo MRI
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netta Levin

Jerusalem, Israel

Location

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 Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 22, 2011

Study Start

September 1, 2012

Primary Completion

January 1, 2019

Study Completion

October 1, 2020

Last Updated

February 6, 2018

Record last verified: 2017-08

Locations

IL(1)