Multiple Sclerosis Clinical Trial

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MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

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Summary

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).

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Full Description

The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.

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Eligibility Criteria

Inclusion Criteria:

All Specimens:

Male or female
Biorepository specimen de-identified of PHI
Specimen meets HTLV Blot 2.4 labeling collection/handling criteria

HTLV Positive Specimens:

Specimens with a known positive infection of HTLV I, HTLV II or HTLV I/II

Neurological Disorders:

Specimens with a diagnosis or symptoms consistent with any of the following neurological disorders:

Acute Disseminated Encephalitis
Amyotrophic Lateral Sclerosis (ALS)
Autonomic Dysfunction
Conus Medularis Syndrome
Chronic Inflammatory Demyelinating Polyneuropathy
Dermatomyositis
HTLV associated myelopathy-tropical spastic paraparesis (HAM-TSP)
Meningitis
Mild Cognitive Impairment
Multiple Sclerosis (MS)
Polymyositis
Spastic Paraparesis
Sciatica

Exclusion Criteria:

HTLV Infected:

specimens with a known infection or history of HIV, HCV or HBV
specimens not meeting specimen labeling collection / handling criteria

Neurological Disorders

specimens not meeting specimen labeling collection / handling criteria

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

150

Study ID:

NCT03226119

Recruitment Status:

Completed

Sponsor:

MP Biomedicals, LLC

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There are 3 Locations for this study

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LABS, Inc.
Philadelphia Pennsylvania, 19123, United States
Qualtex Laboratories
San Antonio Texas, 78201, United States
Eastern Virginia Medical School (EVMS)
Norfolk Virginia, 23507, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

150

Study ID:

NCT03226119

Recruitment Status:

Completed

Sponsor:


MP Biomedicals, LLC

How clear is this clinincal trial information?

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