Expired Study
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Orange, California 92868


Purpose:

The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in patients with multiple sclerosis.


Study summary:

The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 (dextromethorphan [DM]/quinidine [Q])capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of patients with multiple sclerosis (MS) over a 12-week period. The MS patients population enrolled includes patients with relapsing-remitting multiple sclerosis (RRMS) and patients with secondary progressive multiple sclerosis (SPMS).


Criteria:

Main Inclusion Criteria: Multiple Sclerosis (RRMS or SPMS), Clinical history and symptoms of central neuropathic pain (dysesthetic pain)for at least 3 months prior to screening, PRS baseline score = or > 4, No MS relapse within previous 30 days. Main Exclusion Criteria: Personal history of complete heart block, QTc prolongation, or torsades de pointes, family history of congenital QT interval prolongation syndrome, Myasthenia Gravis, BDI score > 19


NCT ID:

NCT01324232


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Orange, California 92868
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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