A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology, Multiple Sclerosis |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 5/19/2018 |
Start Date: | October 18, 2016 |
End Date: | April 20, 2018 |
An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and
immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
Inclusion Criteria:
- Currently receiving one of the following MS medications for at least 3 months:
beta-interferon (any formulation including the pegylated form), glatiramer acetate
(Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), or dimethyl
fumarate (Tecfidera®); OR
- Has not been treated with an MS immunotherapy for the past 6 months (12 months if they
previously received cyclophosphamide or alemtuzumab); OR
- Treatment naïve with established MS diagnosis per criteria by a neurologist.
- Diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
according to revised McDonald criteria
- Baseline Expanded Disability Status Scale (EDSS) between 0 and 6.0, inclusive.
- Brain MRI scan at Screening that did not show evidence of overt vascular lesions,
masses, mass effect or other abnormalities other than those compatible with MS, which
would preclude the participant from undergoing a lumbar puncture/spinal tap for CSF
collection
Exclusion Criteria:
- Diagnosis of primary progressive MS.
- Anticipated maintenance immunomodulator change, either agent or dose
- An MS relapse that occurred within the 30 days prior to randomization AND/OR the
participant has not stabilized from a previous relapse prior to randomization
- Participants for whom MRI is contraindicated
- Participants who have claustrophobia that cannot be medically managed or are unable to
lie still for 1 hour or more for the imaging procedures
- Findings on brain MRI scan indicating any clinically significant brain abnormality
other than MS
- Contraindication for lumbar puncture
We found this trial at
8
sites
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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