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

This study is currently recruiting participants.
Verified November 2012 by Avanir Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01324232
First received: March 23, 2011
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  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.


Condition Intervention Phase
Central Neuropathic Pain
Multiple Sclerosis
 Drug: AVP-923
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Multiple Sclerosis

Resource links provided by NLM:

Drug Information available for: Nuedexta
U.S. FDA Resources

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Pain Rating Scale (PRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: AVP-923
AVP-923 capsules administered twice-a-day, over a 12 week period
Other Name: Nuedexta (AVP-923-20)
Experimental: AVP-923-45 Drug: AVP-923
AVP-923 capsules administered twice-a-day, over a 12 week period
Other Name: Nuedexta (AVP-923-20)
Experimental: AVP-923-30 Drug: AVP-923
AVP-923 capsules administered twice-a-day, over a 12 week period
Other Name: Nuedexta (AVP-923-20)
Experimental: AVP-923-20 Drug: AVP-923
AVP-923 capsules administered twice-a-day, over a 12 week period
Other Name: Nuedexta (AVP-923-20)

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324232

Contacts
Contact: Paul Shin 949.268.5930 PShin@avanir.com
Contact: Joao Siffert, MD 949.268.1174 JSiffert@avanir.com

  Show 106 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

No publications provided

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01324232     History of Changes
Other Study ID Numbers: 11-AVR-130
Study First Received: March 23, 2011
Last Updated: November 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Neuralgia
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013