An Observational Study on the Progression of Clinically Isolated Syndrome to Multiple Sclerosis Over a 2-year Period

NCT01112657 | Completed

• 1 other identifier: EMR200077-504
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, multicentric, observational study with a 2 years recruitment period. The purpose of the study is to observe the multiple sclerosis (MS) progression of subjects since their first episode of neurological event and secondly, to determine status of anti-AQP4 immunoglobulin (IgG) antibody in MS subjects.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Clinical isolated syndrome; Demyelination

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who convert to multiple sclerosis (MS), defined by McDonald criteria (Version 2005), over 2 years from the first episode of Clinically Isolated Syndrome (CIS)

  At each and every visit, routine neurological and or ophthalmologic examinations will be performed to determine whether subject has progress to MS.

  Baseline to 2 years

Secondary Outcomes (4)

• Duration between first episode of neurological event and diagnosis of MS

  Baseline to 2 years

• Proportion of subjects with conventional MS and optic-spinal MS (OSMS)

  Baseline to 2 years

• Proportion of subjects with anti-AQP4 IgG antibody

  Baseline to 2 years

• Association between baseline demographics/disease characteristics and progression to MS

  Baseline to 2 years

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have experienced a single, first clinical event potentially suggestive of MS within the last 2 years from study entry.

You may qualify if:

• Subjects aged between 6-60 years, both inclusive
• Subjects who have experienced a single, first clinical event potentially suggestive of MS within the last 2 years from study entry. The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic, other than paresthesia or vegetative dysfunction
• Subjects who have given written informed consent.

You may not qualify if:

• Subjects with the diagnosis of MS
• Subjects with other disease that could better explain the subject's signs and symptoms
• Subjects who are scheduled to participate in any interventional treatment trial
• Subjects who have any condition that could interfere with MRI evaluation

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (6)

Kaohsiung Medical University, Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Chang-Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, 833, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 201, Taiwan

Location

Chang-Gung Memorial Hospital - Linkou Branch

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Multiple Sclerosis; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ching-Piao Tsai, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: April 28, 2010
• Study Start: November 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

TW (6)