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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01324232
First received: March 23, 2011
Last updated: April 15, 2014
Last verified: April 2014

March 23, 2011
April 15, 2014
September 2011
September 2013   (final data collection date for primary outcome measure)
Pain Rating Scale (PRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Pain Rating Scale (PRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01324232 on ClinicalTrials.gov Archive Site
  • Fatigue Severity Scale (FSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Expanded Disability Status Scale (EDSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • MS Neuropsychological Screening Questionnaire (MSNQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI-II). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale (MAS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • 7-point Numerical Rating Scale (NRS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Fatigue severity scale (FSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Expanded Disability Status Scale (EDSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Multiple Sclerosis Neuropsychological Screening Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI-II) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
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 Multiple Sclerosis

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Central Neuropathic Pain
  • Multiple Sclerosis
Drug: AVP-923
AVP-923 capsules administered twice-a-day, over a 12 week period
Other Name: Nuedexta (AVP-923-20)
  • Placebo Comparator: Placebo
    Intervention: Drug: AVP-923
  • Experimental: AVP-923-45
    Intervention: Drug: AVP-923
  • Experimental: AVP-923-30
    Intervention: Drug: AVP-923
  • Experimental: AVP-923-20
    Intervention: Drug: AVP-923
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2013
September 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Czech Republic,   Poland,   Spain
 
NCT01324232
11-AVR-130
No
Avanir Pharmaceuticals
Avanir Pharmaceuticals
Not Provided
Not Provided
Avanir Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP