Expired Study
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Aurora, Colorado 80045


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


Study is Available At:


Original ID:

11-AVR-130


NCT ID:

NCT01324232


Secondary ID:


Study Acronym:

PRIME


Brief Title:

Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis


Official Title:

A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Avanir Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Actual


Study Dates

Start Date:September 2011
Completion Date:September 2013
Completion Type:Actual
Primary Completion Date:September 2013
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 28, 2018
First Received Date:March 23, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Patient Global Impression of Change (PGIC)
Time Frame:12 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:7-point Numerical Rating Scale (NRS)
Time Frame:12 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Modified Ashworth Scale (MAS)
Time Frame:12 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Symbol Digit Modalities Test (SDMT)
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Beck Depression Inventory (BDI-II).
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:MS Neuropsychological Screening Questionnaire (MSNQ)
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pittsburgh Sleep Quality Index (PSQI)
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Expanded Disability Status Scale (EDSS)
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Fatigue Severity Scale (FSS)
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pain Rating Scale (PRS)
Time Frame:12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:AVP-923
Description:AVP-923 capsules administered twice-a-day, over a 12 week period
Arm Name:AVP-923-45
Other Name:Nuedexta (AVP-923-20)
Intervention Type:Drug
Name:Placebo
Description:Matching placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Experimental
Arm Name:AVP-923-45
Study Arm Type:Experimental
Arm Name:AVP-923-30
Study Arm Type:Experimental
Arm Name:AVP-923-20

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Avanir Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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