Chronic Vegetative StatePhase 1RPh-in-CVSNCT01438684
The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study
A Phase 1 study testing RPh201 and Saline in people with Chronic Vegetative State, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. 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
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Oct 2020
- Phase
- Phase 1
- 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 state patients
Who cannot join
- allergic reaction to treatment
- patients that can not undergo MRI
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State
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.
- Conditions
- Chronic Vegetative State
- Being tested
- RPh201, Saline
- Keywords
- chronic vegetative state, 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.
RPh201Drug
400 microliter s.c. twice a week for 3 months
SalineDrug
400 microliter Saline solution s.c. twice a week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| RPh201 group | Active comparator | 7 patients will receive the treatment Receives: Drug: RPh201 |
| non RPh201 group | Placebo comparator | 3 patients will receive placebo Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Functional magnetic resonance imaging of cortical activity
3 scans will be performed: before treatment, after three months of treatment and 3 months after cessation of treatment. Scanning sessions will include a hierarchical auditory paradigm, an imagery task and resting state fMRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2012
- Primary completionJan 2019 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: due to lack of supply of medication and technical problems with the MRI
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438684
- Sponsor's protocol ID
- 026011- HMO-CTIL
- Acronym
- RPh-in-CVS
- Status last verified
- Aug 2017
- First submitted
- 21 Sep 2011
- Last updated
- 6 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State
- ClinicalTrials.gov ID
- NCT01438684
- Acronym / sponsor ID
- RPh-in-CVS / 026011- HMO-CTIL
- Conditions
- Chronic Vegetative State
- Keywords
- chronic vegetative state, functional MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: due to lack of supply of medication and technical problems with the MRI
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Sep 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPh201 group | Active comparator | Drug: RPh2017 patients will receive the treatment |
| non RPh201 group | Placebo comparator | Drug: Saline3 patients will receive placebo |
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 state patients
Key exclusion criteria (3 listed)
- allergic reaction to treatment
- patients that can not undergo MRI
- 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 |
|---|---|---|
| RPh201400 microliter s.c. twice a week for 3 months | Drug | RPh201 group |
| Saline400 microliter Saline solution s.c. twice a week for 3 months | Drug | non RPh201 group |
Primary outcome
consciousness level measured clinically
Time frame: 6 months
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.
1 secondary outcome
Functional magnetic resonance imaging of cortical activity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPh201 and Saline in people with Chronic Vegetative State, run by Hadassah Medical Organization at 1 site in Israel.
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 3 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: paused, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
consciousness level measured clinically (time frame: 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 6 Feb 2018.