The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study (RPh-in-CVS)

Hadassah Medical Center

Status and phase: Suspended; Phase 1

Conditions: Chronic Vegetative State

Treatments: Drug: RPh201; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01438684

026011- HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic vegetative state patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

RPh201 group

Active Comparator group

Description:

7 patients will receive the treatment

Treatment:

Drug: RPh201

non RPh201 group

Placebo Comparator group

Description:

3 patients will receive placebo

Treatment:

Drug: Saline