The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study (RPh-in-CVS)
This study is currently recruiting participants.
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Hadassah Medical Organization
Information provided by (Responsible Party):
Netta Levin, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01438684
First received: September 21, 2011
Last updated: March 20, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 21, 2011 | ||||||||
| Last Updated Date | March 20, 2013 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
consciousness level measured clinically [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE |
consciousness level measured clinically and by functional MRI | ||||||||
| Change History | Complete list of historical versions of study NCT01438684 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Functional magnetic resonance imaging of cortical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ] 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 |
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| Original Secondary Outcome Measures ICMJE |
long lasting effects of the drug | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study | ||||||||
| Official Title ICMJE | Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Vegetative State | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | October 2014 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01438684 | ||||||||
| Other Study ID Numbers ICMJE | 026011- HMO-CTIL | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Netta Levin, Hadassah Medical Organization | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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