Spinal Cord InjuriesNCT00592722
A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients
An observational study of Spinal Cord Injuries, run by China Spinal Cord Injury Network at 5 sites in 2 countries.
Trial summary
To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI therapies in forthcoming randomized controlled multi-centre clinical trials following international standards and guidelines Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2007to Mar 2009
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Hospital
Who may be able to join
- Male or female adult subjects, 18 to 60 years of age;
- Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI);
- The diagnosis of SCI was confirmed by MRI; and
- Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures
Who cannot join
- Severe head injury;
- Is medically or mentally unstable according to the judgement of the Investigator;
- History of Multiple Sclerosis or peripheral demyelinating disease;
- Likely to have experimental therapy;
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
China3 sites
301 Orthopedic Hospital
Beijing
Second Affiliated Hospital of Third Military Medcial University
Chongqing
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Taiwan2 sites
Buddhist Tzu Chi General Hospital
Hualien City
China Medical University Hospital
Taichung
About this study
To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI therapies in forthcoming randomized controlled multi-centre clinical trials following international standards and guidelines
- Conditions
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study outcomes will be the subject recruitment rate, the subject drip out rate, the number of missing values and the number of submitted incorrect values
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 posted14 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Spinal Cord Injury Network
- Sponsor type
- Research network
- Collaborators
- The University of Hong Kong
- Investigators
- Wise Young, MD, PhD, Study director, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592722
- Sponsor's protocol ID
- CN100b
- Status last verified
- Jul 2009
- First submitted
- 2 Jan 2008
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT00592722
- Acronym / sponsor ID
- CN100b
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- China Spinal Cord Injury NetworkResearch network
- Collaborators
- The University of Hong Kong
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Jan 2008 (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.
To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI therapies in forthcoming randomized controlled multi-centre clinical trials following international standards and guidelines
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Hospital
Key inclusion criteria (4 listed)
- Male or female adult subjects, 18 to 60 years of age;
- Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI);
- The diagnosis of SCI was confirmed by MRI; and
- Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures
Key exclusion criteria (5 listed)
- Severe head injury;
- Is medically or mentally unstable according to the judgement of the Investigator;
- History of Multiple Sclerosis or peripheral demyelinating disease;
- Likely to have experimental therapy;
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary study outcomes will be the subject recruitment rate, the subject drip out rate, the number of missing values and the number of submitted incorrect values
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2009.
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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.
Wise Young, MD, PhD study director
The University of Hong Kong
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by China Spinal Cord Injury Network at 5 sites in 2 countries.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China, Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary study outcomes will be the subject recruitment rate, the subject drip out rate, the number of missing values and the number of submitted incorrect values (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 3 Jul 2009.