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

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ClinicalTrials.gov Identifier: NCT01324232
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Central Neuropathic Pain Multiple Sclerosis Drug: AVP-923 Drug: Placebo Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Matching placebo
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)



Primary Outcome Measures :
  1. Pain Rating Scale (PRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Fatigue Severity Scale (FSS) [ Time Frame: 12 weeks ]
  2. Expanded Disability Status Scale (EDSS) [ Time Frame: 12 weeks ]
  3. Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 12 weeks ]
  4. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 weeks ]
  5. MS Neuropsychological Screening Questionnaire (MSNQ) [ Time Frame: 12 weeks ]
  6. Beck Depression Inventory (BDI-II). [ Time Frame: 12 weeks ]
  7. Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 weeks ]
  8. Modified Ashworth Scale (MAS) [ Time Frame: 12 Weeks ]
  9. 7-point Numerical Rating Scale (NRS) [ Time Frame: 12 Weeks ]
  10. Patient Global Impression of Change (PGIC) [ Time Frame: 12 Weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324232


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Sponsors and Collaborators
Avanir Pharmaceuticals

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01324232     History of Changes
Other Study ID Numbers: 11-AVR-130
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neuralgia
Pathologic Processes
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
Dextromethorphan
Quinidine
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents