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

Hadassah Medical Center

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Chronic Vegetative State

Treatments: Dietary Supplement: RPh201; Dietary Supplement: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01417299

0260-11-HMO

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic vegetative patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

RPh201 group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: RPh201

placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: saline