A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

This study has been completed.
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT00592722
First received: January 2, 2008
Last updated: July 2, 2009
Last verified: July 2009

January 2, 2008
July 2, 2009
December 2007
December 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00592722 on ClinicalTrials.gov Archive Site
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A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients
A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

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

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Hospital

Spinal Cord Injuries
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female adult subjects, 18 to 60 years of age;
  2. Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI);
  3. The diagnosis of SCI was confirmed by MRI; and
  4. 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

Exclusion Criteria:

  1. Severe head injury;
  2. Is medically or mentally unstable according to the judgement of the Investigator;
  3. History of Multiple Sclerosis or peripheral demyelinating disease;
  4. Likely to have experimental therapy;
  5. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Taiwan
 
NCT00592722
CN100b
No
Director, Clinical Trial Centre, The University of Hong Kong
China Spinal Cord Injury Network
The University of Hong Kong
Study Director: Wise Young, MD, PhD The University of Hong Kong
China Spinal Cord Injury Network
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP