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Dose Escalation Study to Eval...

Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS

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Detailed Description

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This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose

Conditions

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Secondary Progressive Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Placebo

Intervention Type BIOLOGICAL

Baminercept

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of Secondary Progressive Multiple Sclerosis
* Aged 18 to 57 years old, at the time of informed consent

Exclusion Criteria

* History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis)
* Inability in the opinion of the Investigator to comply with study requirements
* Other protocol-defined criteria may apply

Minimum Eligible Age

18 Years

Maximum Eligible Age

57 Years

Eligible Sex

ALL

Accepts Healthy Volunteers