- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01324232
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis (PRIME)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1437JCH
- Hospital Churruca-Visca
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Buenos Aires, Argentina, CP1117ABD
- Fundación Argentina Contra las Enfermedades Neurológicas del Envejecimiento - FACENE
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Ciudad Autonoma de Buenos Aires, Argentina
- Medeos - Centro de Medicina Integral e Investigación Clínica
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Santa Fe, Argentina
- Instituto de Neurología y Neurorrehabilitación del Litoral
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
- Hospital Britanico de Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1126AAB
- Instituto de Neurologia Cognitiva
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
- Hospital Italiano
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Ciudad de Buenos Aires, Buenos Aires, Argentina, C1015ABR
- Instituto Argentino de Investigacion Neurologica
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Brno, Czechia
- Fakultni Nemocnice u sv. Anny v Brne
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Hradec Kralove, Czechia, 500 0
- Fakultni nemocnice Hradec Kralove
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Jihlava, Czechia, 586 33
- Nemocnice Jihlava, příspěvková organizace
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Ostrava, Czechia, 708 52
- Fakultni nemocnice Ostrava
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Praha 2, Czechia, 128 21
- Vseobecna fakultni nemocnice v Praze
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Czeladz, Poland, 41-250
- Szpital Powiatowy w Czeladzi
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Gdansk, Poland, 80-803
- Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
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Katowice, Poland, 40-594
- Diagnomed Clinical Research Sp. z.o.o.
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Katowice, Poland, 40-752
- Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
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Katowice, Poland
- Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA
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Konskie, Poland, 26-200
- Zespol Opieki Zdrowotnej w Konskich
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Plewiska, Poland, 62-064
- Specjalistyczny Gabinet Neurologiczny
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Poznan, Poland, 61-289
- Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
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Szczecin, Poland, 70-215
- Osrodek Badan Klinicznych Indywidualnej Specjalistycznej Praktyki Lekarskiej
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Santa Cruz De Tenerife, Spain, 38010
- Hospital Univ. Nuestra Sra. De La Candelaria
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Sevilla, Spain, 41009
- Hospital Universitario Virgen Macarena
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Cataluña
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Barcelona, Cataluña, Spain, 08003
- Hospital del Mar
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Barcelona, Cataluña, Spain, 08035
- Hospital Vall D´Hebron
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Girona, Cataluña, Spain, 17007
- Hospital Universitari de Girona Dr. Josep Trueta
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Murcia
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El Palmar, Murcia, Spain, 30120
- Hospital Universitario Virgen de La Arrixaca
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Alabama
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Cullman, Alabama, United States, 35058
- North Central Neurology Associates PC
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Arizona
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Phoenix, Arizona, United States, 85013
- St. Joseph's Hospital Medical Center
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California
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Berkeley, California, United States, 94705
- Alta Bates Summit Medical Center
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Orange, California, United States, 92868
- University of California, Irvine
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San Diego, California, United States, 92103
- Coordinated Clinical Research
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San Francisco, California, United States, 94158
- University of California, San Francisco
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Florida
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Maitland, Florida, United States, 32751
- Neurology Associates, PA
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Naples, Florida, United States, 34102
- Collier Neurologic Specialists
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North Palm Beach, Florida, United States, 33408
- Laszlo J. Mate, MD
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Ormond Beach, Florida, United States, 32174
- Neurology Associates of Ormond Beach
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Pompano Beach, Florida, United States, 33060
- Neurological Associates
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Ponte Vedra Beach, Florida, United States, 32082-4040
- Neurologique Foundation
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Saint Petersburg, Florida, United States, 33713
- Suncoast Neuroscience Associates, Inc.
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Tampa, Florida, United States, 33612
- University of South Florida
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Vero Beach, Florida, United States, 32960
- Geodyssey Research, LLC
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Georgia
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Atlanta, Georgia, United States, 30309
- Shepard Center
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Illinois
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Chicago, Illinois, United States, 60612
- Rush-Presbyterian St. Luke's Medical Center
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Northbrook, Illinois, United States, 60062
- Consultants In Neurology
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Indiana
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Indianapolis, Indiana, United States, 46256
- Josephson Wallack Munshower Neurology, P.C.
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Kansas
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Lenexa, Kansas, United States, 66214
- MidAmerica Neuroscience Institute
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Michigan
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Clinton Township, Michigan, United States, 48035
- Michigan Neurology Associates, P.C.
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Detroit, Michigan, United States, 48201
- Wayne State University
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Montana
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Great Falls, Montana, United States, 59405
- Advanced Neurology Specialists
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Nebraska
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Lincoln, Nebraska, United States, 68506
- Neurology Associates PC
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New York
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Albany, New York, United States, 12208
- Albany Medical Center Hospital
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New York, New York, United States, 10003
- NYU-Hospital for Joint Diseases
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Rochester, New York, United States, 14642
- University of Rochester
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Stony Brook, New York, United States, 11794
- SUNY at Stony Brook
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Carolinas Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Drexel University College of Medicine
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Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Health System
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Tennessee
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Franklin, Tennessee, United States, 37064
- Advanced Neurosciences Institute
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Utah
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Salt Lake City, Utah, United States, 84103
- Rocky Mountain MS Clinic
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Virginia
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Henrico, Virginia, United States, 23226
- Neurological Associates
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Vienna, Virginia, United States, 22182
- MS Center of Greater Washington
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Washington
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Seattle, Washington, United States, 98122
- Swedish Medical Center
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Tacoma, Washington, United States, 98405
- MultiCare Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Main Inclusion Criteria:
Multiple Sclerosis (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS]), Clinical history and symptoms of central neuropathic pain (dysesthetic pain) for at least 3 months prior to screening, pain rating scale (PRS) baseline score = or > 4, No MS relapse within previous 30 days.
Main Exclusion Criteria:
Personal history of complete heart block, QT interval corrected for heart rate (QTc) prolongation, or torsades de pointes, family history of congenital QT interval prolongation syndrome, Myasthenia Gravis, Beck Depression Inventory Second Edition (BDI-II) score > 19
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Matching placebo capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.
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Experimental: AVP-923-45
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AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.
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Experimental: AVP-923-30
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AVP-923-30 (dextromethorphan 30 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.
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Experimental: AVP-923-20
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AVP-923-20 (dextromethorphan 20 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association Between the Dextromethorphan Plasma Concentration and the Change From Baseline Pain Rating Scale (PRS) Score to the Average Pain Rating Scale Score During Days 57 Through 84
Time Frame: Baseline; Days 57 through 84 (PRS score); Days 22 and 50 (dextromethorphan plasma concentrations)
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PRS required participants to rate their pain over the past 12 hours (hrs) on a scale of 0 to 10 (0=no pain; 10=worst possible pain).
Baseline (B) PRS was defined as the average of the PRS scores in the last 7 days collected prior to the B visit.
If participants did not have at least 4 PRS scores during the last 7 days prior to the B visit, then the average of up to 7 of the most recent PRS scores available prior to the B visit was used.
Post-B PRS was the average of Days 57 through 84 values.
For participants who did not have any PRS scores during Days 57 through 84, the average of the last 7 available post-B PRS scores was used.
Change from B was calculated as the post-B score minus B score.
The average logarithms of dextromethorphan plasma concentrations (Cmax) on Days 22 and 50 are reported in primary outcome measure #2 below.
Pearson correlation was calculated between Cmax as one group of data across the reporting groups and Change from Baseline in PRS score.
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Baseline; Days 57 through 84 (PRS score); Days 22 and 50 (dextromethorphan plasma concentrations)
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Average Logarithms of Dextromethorphan (DM) Plasma Concentrations (Cmax) on Days 22 and 50
Time Frame: 0 to 3 hours post-dose on Day 22 and 50
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The average of the logarithms of the DM plasma concentrations on Days 22 and 50 were presented.
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0 to 3 hours post-dose on Day 22 and 50
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the Adjusted Mean Change From Baseline PRS Score to the Average PRS Score During Days 57 Through 84
Time Frame: Baseline; Days 57 through 84
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The PRS required participants to rate their pain over the past 12 hours on a scale of 0 to 10 (0=no pain; 10=worst possible pain) by circling the number that best described their pain on average over the past 12 hours.
Baseline PRS was defined as the average of the PRS scores in the last 7 days collected prior to the Baseline visit.
If participants did not have at least 4 PRS scores during the last 7 days prior to the Baseline visit, then the average of up to 7 of the most recent PRS scores available prior to the Baseline visit was used.
Post-Baseline PRS was the average of the Day 57 through 84 values.
For participants who did not have any PRS scores during Days 57 through 84, the average of the last 7 available post-Baseline PRS scores was used.
Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
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Baseline; Days 57 through 84
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Mean Change From Baseline in Fatigue Severity Scale (FSS) Scores at Days 57 Through 84
Time Frame: Baseline; Days 57 through 84
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The FSS questionnaire consisted of 9 statements that attempted to explore the severity of fatigue symptoms in participants with MS and other conditions, including chronic fatigue immune dysfunction syndrome and systemic lupus erythematosus, and was designed to differentiate fatigue from clinical depression because both share some of the same symptoms.
Participants were asked to respond to each statement on a scale of 1 to 7, with 1 indicating "Strongly Disagree" and 7 indicating "Strongly Agree."
Total score ranging from 9 to 63, was computed as the sum of the sub-scores for all 9 statements; a higher score indicated increasing fatigue.
Baseline was defined as last non-missing measurement prior to dosing.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Post-Baseline FSS score was the average of Day 57 through 84 values.
The analysis was carried out using an ANCOVA model, with the FSS change from Baseline to Days 85 as the dependent variable,
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Baseline; Days 57 through 84
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Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Days 22 and 85
Time Frame: Baseline; Days 22 and 85
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The EDSS, a method of quantifying disability in participants with MS was based on neurological examination of 8 functional systems (FS) (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other) that allowed neurologists to assign a FS score to each of these systems.
Neurological findings in each FS were scored on a scale of 0 (low level of problems) to 5 (high level of problems).
The "other" category was not rated numerically but measured disability related to a particular issue, like motor loss.
A total averaged EDSS score was then calculated on a scale of 0 (normal) to 10 (death from MS).
The total EDSS score was determined by 2 factors: gait and FS scores.
A higher score indicated greater disability.
Baseline was defined as last non-missing measurement prior to dosing.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
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Baseline; Days 22 and 85
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Mean Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Scores at Day 85
Time Frame: Baseline; Day 85
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MSIS-29, an instrument measuring the physical (20 items) and psychological (9 items) impact of MS from the participants' perspective was used to evaluate therapeutic effectiveness from the participants' perspective.
Participants were asked to circle the response that best described the impact of MS on daily life on a scale of 0 (not at all) to 5 (extremely).
The total MSIS-29 score ranged from 0 to 145, was calculated as the sum of the sub-scores for all 29 questions, with lower scores indicating better quality of life.
Baseline was defined as last non-missing measurement prior to dosing.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
The analysis was carried out using an ANCOVA model, with the MSIS-29 score change from Baseline to Day 85 as the dependent variable, treatment group as a fixed effect, and the Baseline MSIS-29 as a covariate.
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Baseline; Day 85
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Mean Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at Day 85
Time Frame: Baseline; Day 85
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PSQI, a self-rated questionnaire was used to assess sleep quality and disturbances over a 1-month time interval.
A total of 19 individual items generated 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component was scored from 0 (no difficulty) to 3 (severe difficulty).
The sum of the scores for the 7 components yielded 1 global score (ranging from 0 to 21).
Higher PSQI score indicated worse quality of sleep.
Baseline was defined as last non-missing measurement prior to dosing.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
The analysis was carried out using an ANCOVA model, with the PSQI change from Baseline to Day 85 as the dependent variable, treatment group as a fixed effect, and the Baseline PQIS as a covariate.
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Baseline; Day 85
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Mean Change From Baseline in MS Neuropsychological Screening Questionnaire (MSNQ) Scores at Day 85
Time Frame: Baseline; Day 85
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MSNQ, a self-reporting, 15-item questionnaire was used to screen for cognitive impairment in participants with MS.
Participants (or their informants) scored each item on a scale from 0 (not at all) to 4 (often and greatly interferes with life).
The total MSNQ score was calculated as the sum of the sub-scores for all 15 questions and thus ranged from 0 to 60.
A higher score indicated greater impairment.
Baseline was defined as last non-missing measurement prior to dosing.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
The analysis was carried out using an ANCOVA model, with the MSNQ score change from Baseline to Day 85 as the dependent variable, treatment group as a fixed effect, and the Baseline MSNQ as a covariate.
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Baseline; Day 85
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Mean Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Day 85
Time Frame: Baseline; Day 85
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BDI-II, a 21-item, self-reported instrument was used to assess the existence and severity of symptoms of depression.
Each item corresponded to a symptom of depression and as scored on a 4-point scale, ranging from 0 to 3. Participants were asked to consider each statement as it related to the way they have felt for the past 2 weeks.
Each of the 21 items were summed to give a single score for the BDI-II (ranging from 0 to 63).
A total score of 0 to 13 indicated minimal depression, a score of 14 to 19 indicated mild depression, a score of 20 to 28 indicated moderate depression, and a score of 29 to 63 indicated severe depression.
Baseline was defined as last non-missing measurement prior to dosing.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
The analysis was carried out using an ANCOVA model, with the BDI-II change from Baseline to Day 85 as the dependent variable, treatment group as a fixed effect, and the Baseline BDI-II as a covariate.
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Baseline; Day 85
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Mean Change From Baseline in Symbol Digit Modalities Test (SDMT) Scores at Day 85
Time Frame: Baseline; Day 85
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The SDMT assessed organic cerebral dysfunction in both children (8 years and older) and adults.
The SDMT involved a simple substitution task that normal participants could easily perform.
Using a reference key, the examinee had 90 seconds to pair specific numbers with given geometric figures.
The SDMT score was the total correct response (not counting errors) in 90 seconds and ranged from 0 to 110.
Lower scores indicated increased dysfunction.
Baseline was defined as last non-missing measurement prior to dosing.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
The analysis was carried out using an ANCOVA model, with the SDMT change from Baseline to Day 85 as the dependent variable, treatment group as a fixed effect, and the Baseline SDMT as a covariate.
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Baseline; Day 85
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Mean Numerical Rating Scale (NRS) Scores at Days 22, 50, and 85
Time Frame: Days 22, 50, and 85
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The NRS was an 11-point scale for participant self-reporting of pain.
The overall scores ranged from 0 (no spasticity) to 10 (worst possible spasticity).
Higher scores indicated increased aggression.
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Days 22, 50, and 85
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Mean Overall Patient Global Impression of Change (PGIC) Scores at Day 85
Time Frame: Day 85
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The PGIC was a standard, validated 7-point categorical scale.
The participant was asked to assess the overall change in his or her central neuropathic pain symptoms since entry into the study on a scale of 0 to 7 (0=much better; 7=much worse).
Higher scores indicated worsening.
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Day 85
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Modified Ashworth Scale (MAS) Scores
Time Frame: Baseline; Day 85
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MAS is not considered as a true endpoint.
MAS scores were assessed at Baseline only.
Change from Baseline could not be calculated because data for the later timepoints was not collected.
|
Baseline; Day 85
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Multiple Sclerosis
- Sclerosis
- Neuralgia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Anti-Infective Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Membrane Transport Modulators
- Cytochrome P-450 Enzyme Inhibitors
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cytochrome P-450 CYP2D6 Inhibitors
- Respiratory System Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Antitussive Agents
- Adrenergic alpha-Antagonists
- Dextromethorphan
- Quinidine
Other Study ID Numbers
- 11-AVR-130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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