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WithdrawnNCT01181089Updated Sep 16, 2013

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)

A Phase 1/2 interventional study of Placebo and Baminercept in Secondary Progressive Multiple Sclerosis, sponsored by Biogen. Withdrawn. Open to participants aged 18 Years to 57 Years. Per ClinicalTrials.gov, last updated 2013-09-16.

Sponsored by Biogen · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 57 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 884 are open to participants now.

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Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 57 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Interventions

  • BiologicalPlacebo
  • BiologicalBaminercept
06

What researchers measure

Primary outcomes

  1. Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo

    Time frame: after 4 months of treatment

Secondary outcomes

  1. Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo

    Time frame: 8 months (4 months on drug, 4 months post-drug)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01181089
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Aug 13, 2010
Start date
Sep 2010
Last update
Sep 16, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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