A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With… (NCT03319732) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS
United States323 participantsStarted 2018-04-03
Plain-language summary
Spasticity is a common complication in MS and occurs in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in patients with MS.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Subjects 18 to 65 years of age, inclusive.
✓. An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either relapsing-remitting \[RR\] or secondary-progressive \[SP\] course) that manifests a documented history of spasticity for at least 6 months prior to Baseline.
Exclusion criteria
✕. Is willing to continue on open-label treatment with AERT as described in this protocol.
✕. If receiving disease-modifying medications (eg, interferons approved for MS, glatiramer acetate, natalizumab, fingolimod, or mitoxantrone), there must be no change in dose for at least 3 months prior to Baseline, and the subject must be willing to maintain this treatment dose for the duration of the study. If receiving AMPYRA® (dalfampridine, fampridine, 4 amino pyridine), subject must be at a stable dose for at least 3 months prior to Baseline.
✕. Stable regimen for at least 1 month prior to Baseline for all medications and non pharmacological therapies that are intended to alleviate spasticity.
✕. Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement.
✕. Creatinine clearance, as calculated by the glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease Study (MDRD) formula, of \>50 mL/minute.
✕. Use of a medically highly effective form of birth control (see Section 7.8 of the protocol) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects).
✕
What they're measuring
1
Number of Participants With Adverse Events, Change in Vital Signs, Clinical Laboratory Test Results, 12-lead ECGs, USP Questionnaire, and C-SSRS Results