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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592722
• Other study ID #: CN100b
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: July 2, 2009
• Start date: December 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2009
• Source: China Spinal Cord Injury Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeTaiwan: Institutional Review Board
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries

Locations

Country	Name	City	State
China	301 Orthopedic Hospital	Beijing
China	Second Affiliated Hospital of Third Military Medcial University	Chongqing
China	First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
Taiwan	Buddhist Tzu Chi General Hospital	Hualien
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Spinal Cord Injury Network	The University of Hong Kong

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months	No