Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 4/21/2016 |
Start Date: | October 2013 |
End Date: | March 2015 |
A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis
This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4
doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing
Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for
minimum treatment duration of 40 weeks.
doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing
Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for
minimum treatment duration of 40 weeks.
Inclusion Criteria:
- Male or female, between the ages of 18 and 60 years
- Subject is able to learn and self-administer subcutaneous injections (a care-giver
may be trained to inject the subject)
- Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis
(RRMS) (according to the 2010 McDonald MS diagnostic criteria)
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Any multiple sclerosis categorized as primary progressive, secondary progressive or
progressive relapsing
- Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for
MRI
- Any requirement for continuous systemic glucocorticoid administration during the
trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or
Betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
- Contraindication to Copaxone use
- Other protocol defined exclusion criteria could apply
We found this trial at
34
sites
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