Chronic Vegetative StatePhase 1/2CVSNCT01417299
The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements
A Phase 1/2 study testing RPh201 and saline in people with Chronic Vegetative State, run by Hadassah Medical Organization.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Vegetative State
- What is being tested?
- RPh201 and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic vegetative patients
Who cannot join
- Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
About this study
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.
- Conditions
- Chronic Vegetative State
- Being tested
- RPh201, saline
- Keywords
- chronic vegetative state, RPh201, functional MRI
- Medical subject headings
- Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPh201Dietary supplement
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
salineDietary supplement
Patients will receive 400 microliter s.c., of saline twice a week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| RPh201 group | Active comparator | Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months Receives: Dietary Supplement: RPh201 |
| placebo group | Placebo comparator | Patients will receive 400 microliter s.c., of saline twice a week for 3 months Receives: Dietary Supplement: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 months
Secondary outcomes (1)
change in the awareness status of the patients.
clinical and fMRI assessment will be performed 1 month following treatment cessation
Measured: 1 month following the end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: This record is an additional copy of the study listed above
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Vegetative StateStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Tamir Ben-Hur, MD PhD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417299
- Sponsor's protocol ID
- 0260-11-HMO
- Acronym
- CVS
- Status last verified
- Aug 2011
- First submitted
- 15 Aug 2011
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements
- ClinicalTrials.gov ID
- NCT01417299
- Acronym / sponsor ID
- CVS / 0260-11-HMO
- Conditions
- Chronic Vegetative State
- Keywords
- chronic vegetative state, RPh201, functional MRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This record is an additional copy of the study listed above
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPh201 group | Active comparator | Dietary Supplement: RPh201Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months |
| placebo group | Placebo comparator | Dietary Supplement: salinePatients will receive 400 microliter s.c., of saline twice a week for 3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic vegetative patients
Key exclusion criteria (1 listed)
- Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPh201Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months | Dietary supplement | RPh201 group |
| salinePatients will receive 400 microliter s.c., of saline twice a week for 3 months | Dietary supplement | placebo group |
Primary outcome
change in the awareness status of the patients.
Time frame: 3-6 months
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.
1 secondary outcome
change in the awareness status of the patients.
Time frame: 1 month following the end of the trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
Related trials for Chronic Vegetative State
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
Not yet recruiting
Temporal Interference Stimulation for Disorders of Consciousness
Disorder of Consciousness, Minimally Conscious State
Not yet recruiting
AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness
Disorders of Consciousness, Vegetative State
Not yet recruitingObservational study
Multimodal Assessment and Prognosis in Disorders of Consciousness After Severe Brain Injury (CyDoC-MAP)
Consciousness Disorders, Persistent Vegetative State
Enrolling by invitation
Prognostication of Recovery in Early Disorders of Consciousness Study
Disorder of Consciousness, Comatose
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamir Ben-Hur, MD PhD principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RPh201 and saline in people with Chronic Vegetative State, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the awareness status of the patients. (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.