Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis
Information source: Acorda Therapeutics
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Dalfampridine-ER 5mg (Drug); Dalfampridine-ER 10mg (Drug); Placebo (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Acorda Therapeutics Official(s) and/or principal investigator(s): Andrew R. Blight, PhD, Study Director, Affiliation: Acorda Therapeutics Mark Agius, MD, Principal Investigator, Affiliation: University of California, Davis Angela Applebee, MD, Principal Investigator, Affiliation: University of Vermont Medical Center S. A Azizi, MD, PhD, Principal Investigator, Affiliation: Temple University Hospital Francois Bethoux, MD, Principal Investigator, Affiliation: The Cleveland Clinic Christopher Bever, Jr., MD, Principal Investigator, Affiliation: University of Maryland, Maryland Center for Multiple Sclerosis Eric Borresen, MD, Principal Investigator, Affiliation: Metrolina Medical Research Aaron Boster, MD, Principal Investigator, Affiliation: Ohio State University, Columbus Ann Camac, MD, Principal Investigator, Affiliation: Lahey Clinic Mark Cascione, MD, Principal Investigator, Affiliation: Axiom Clinical Research of Florida Jane Chan, MD, Principal Investigator, Affiliation: Veterans Administration Medical Center Warren Chumley, MD, Principal Investigator, Affiliation: Associates in Neurology, PSC Joanna Cooper, MD, Principal Investigator, Affiliation: Alta Bates Summit Medical Center Joy Derwenskus, DO, Principal Investigator, Affiliation: Northwestern University Adam DiDio, MD, Principal Investigator, Affiliation: Suncoast Neuroscience Associates, Inc. Dennis Dietrich, MD, Principal Investigator, Affiliation: Advanced Neurology Specialists Geoffery Eubank, MD, Principal Investigator, Affiliation: Neurological Research Institute Steven Freedman, MD, Principal Investigator, Affiliation: Raleigh Neurology Associates Daniel Giang, MD, Principal Investigator, Affiliation: Loma Linda University Medical Center Lawrence Goldstick, MD, Principal Investigator, Affiliation: Neurology Specialists, Inc. Andrew Goodman, MD, Principal Investigator, Affiliation: University of Rochester Mark Gudesblatt, MD, Principal Investigator, Affiliation: Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C. Barry Hendin, MD, Principal Investigator, Affiliation: Phoenix Neurological Associates, LTD Craig Herrman, MD, Principal Investigator, Affiliation: Josephson Wallack Munshower Neurology, PC William Honeycutt, MD, Principal Investigator, Affiliation: Neurology Associates, PA Bruce Hughes, MD, Principal Investigator, Affiliation: Ruan Neurology Clinical Research Center Samuel Hunter, MD, PhD, Principal Investigator, Affiliation: Advanced Neurosciences Institute George Hutton, MD, Principal Investigator, Affiliation: Maxine Mesinger Multiple Sclerosis Clinic; Baylor College of Medicine Dina Jacobs, MD, Principal Investigator, Affiliation: University of Pennsylvania Todd Janus, MD, PhD, Principal Investigator, Affiliation: Iowa Health Des Moines Omar Khan, MD, Principal Investigator, Affiliation: Wayne State University Bhupendra Khatri, MD, Principal Investigator, Affiliation: Aurora Saint Luke's Medical Center Kiren Kresa-Reahl, MD, Principal Investigator, Affiliation: Charleston Area Medical Center Health Education and Research Institute, Inc. Christopher LaGanke, MD, Principal Investigator, Affiliation: North Central Neurology Associates, PC Sharon Lynch, MD, Principal Investigator, Affiliation: The University of Kansas Medical Center Michele Mass, MD, Principal Investigator, Affiliation: Oregon Health and Science University David Mattson, MD, PhD, Principal Investigator, Affiliation: Indiana University Angeli Mayadev, MD, Principal Investigator, Affiliation: Swedish Neuroscience Institute Donald Negroski, MD, Principal Investigator, Affiliation: Negroski, Stein, Sutherland and Hanes Neurology Stephen Newman, MD, Principal Investigator, Affiliation: Island Neurological Associates, PC Gabriel Pardo, MD, Principal Investigator, Affiliation: Mercy Multiple Sclerosis Center of Oklahoma Mercy Neuroscience Institute C. Fish Greenfield, MD, Principal Investigator, Affiliation: Texas Neurology, PA Rekha Pillai, MD, Principal Investigator, Affiliation: Neurology Clinic, PC T. Hemanth Rao, MD, Principal Investigator, Affiliation: The Neurological Institute, PA Syed Rizvi, MD, Principal Investigator, Affiliation: Rhode Island Hospital Matthew Roller, MD, Principal Investigator, Affiliation: Altru Health System Research Center Michael Rossen, MD, PhD, Principal Investigator, Affiliation: Springfield Neurology Associates, LLC Alan Schulman, MD, Principal Investigator, Affiliation: Neurological Associates James S Shafer, MD, Principal Investigator, Affiliation: The Multiple Sclerosis Center of Vero Beach Jatin Shah, MD, Principal Investigator, Affiliation: Arizona Neurological Institute William Sheremata, MD, Principal Investigator, Affiliation: University of Miami School of Medicine, Dept. of Neurology Brian Steingo, MD, Principal Investigator, Affiliation: Neurological Associates James Storey, Jr, MD, Principal Investigator, Affiliation: Upstate Clinical Research, LLC Ben Thrower, MD, Principal Investigator, Affiliation: Shepherd Center, Inc. Carlo Tornatore, MD, Principal Investigator, Affiliation: Georgetown University Hospital K A Lloyd, MD, Principal Investigator, Affiliation: Hampton Roads Neurology Anthony Turel, Jr, MD, Principal Investigator, Affiliation: The Pennsylvania State University, Milton S. Hershey Medical Center Sibyl E Wray, MD, Principal Investigator, Affiliation: Sibyl E. Wray, MD, Neurology, PC Daniel Wynn, MD, Principal Investigator, Affiliation: Consultants in Neurology Ltd. Robert Yapundich, MD, Principal Investigator, Affiliation: Unifour Medical Research, LLC
Summary
The purpose of this study is to investigate the safety and efficacy of a lower dose of
dalfampridine extended release tablets compared to the currently approved dose in improving
walking in Multiple Sclerosis (MS) patients.
Clinical Details
Official title: Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Doses of Oral Dalfampridine Extended Release Tablets (5 mg and 10 mg Twice Daily) in Patients With Multiple Sclerosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).
Secondary outcome: Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3 Change From Baseline in MSWS-12 at Visit 2 Change From Baseline in Six-Minute Walk Distance at Visit 2 Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3. Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3.
Detailed description:
The current study is designed as a prospective placebo-controlled trial to investigate the
safety and efficacy of a lower dose of dalfampridine extended release tablets (5 mg twice
daily) compared to the approved commercial dose of 10 mg twice daily in improving walking in
MS patients during a four-week period of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has clinically definite Multiple Sclerosis as defined by the MacDonald
Criteria.
- Patient must be 18 to 70 years of age, inclusive (i. e. on or after their 18th
birthday, up to the day before their 71st birthday at the Screening Visit).
- Patient who has previously taken Ampyra® or dalfampridine (fampridine or 4
aminopyridine; 4-AP) in any formulation (including compounded), must have withdrawn
from the drug for at least one month prior to the Screening Visit.
- Patient must be mentally competent to understand and sign the Internal Review Board
(IRB)-approved informed consent prior to the performance of any study-specific
procedures.
- Patient is able to perform all the required study procedures.
- In the judgement of the Investigator, the patient has MS-related walking impairment
but has sufficient ambulatory ability to be able to complete two trials of the Timed
25 Foot Walk (T25FW) at the screening Visit and every study visit thereafter, with
the two trials completed within 5 minutes of one another and in accordance with the
specific instructions provided by the National Multiple Sclerosis Society MS
Functional Composite Manual.
- Patient who is female and of childbearing potential (see Exclusion Criterion 1 for
definition) must have a negative urine pregnancy test at the Screening Visit.
Exclusion Criteria:
- Patient is a female of childbearing potential (i. e., has not had a hysterectomy or
bilateral oophorectomy, or is not at least two years postmenopausal), engaged in
active heterosexual relations and is not using one of the following birth control
methods: tubal ligation, implantable contraception device, oral, patch or injectable
contraceptive, double barrier method, or sexual activity restricted to vasectomized
partner.
- Patient is pregnant or breastfeeding.
- Patient has any history of seizures.
- Patient has moderate or severe renal impairment as defined by a calculated creatinine
clearance of ≤ 50 mL/minute.
- Patient has active urinary tract infection (UTI) at Screening or within the 4 weeks
before Screening.
- Patient has had an onset (as assessed by the treating physician) of an MS
exacerbation within 60 days prior to the Screening Visit.
- Patient has started on a concomitant prescription medication regimen within the last
three weeks, and/or their concomitant medication regimen is expected to change during
the course of the study.
- Patient has received cyclophosphamide (Cytoxan) or mitoxantrone (Novantrone) for MS
treatment within six months prior to the Screening Visit.
- Patient has started a treatment regimen of Betaseron, Avonex, Copaxone, Rebif,
Tysabri, Extavia or Gilenya™ within 90 days prior to the Screening Visit or has had
any change in the dosing regimen of these drugs within 30 days prior to the Screening
Visit.
- Patient has received corticosteroids (other than topical preparations) within 30 days
prior to the Screening Visit and/or is expected to receive regularly scheduled
corticosteroid treatment during the course of the study.
- Patient has been administered botulinum toxin in the lower extremities within six
months prior to the Screening Visit and/or is expected to receive botulinum toxin in
the lower extremities during the course of the study.
- Patient has a known allergy to pyridine-containing substances or any of the inactive
ingredients of the dalfampridine tablet (colloidal silicon dioxide, hydroxypropyl
methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,
and titanium dioxide).
- Patient has a history of drug or alcohol abuse within the past year.
- Patient has clinically significant abnormal laboratory values.
- Patient has angina, uncontrolled hypertension, clinically significant cardiac
arrhythmias, or any other clinically significant cardiovascular abnormality.
- Patient has any medical condition (including psychiatric disease)that would interfere
with the interpretation of the study results or the conduct of the study.
- Patient has participated in an investigational trial 30 days prior to Screening Visit
or plans to enroll in another investigational trial at any time during this study.
Non-drug (i. e. observational, registry) and non- medical device trials are
allowed.
Locations and Contacts
North Central Neurology Associates, PC, Cullman, Alabama, United States
Phoenix Neurological Associates, Ltd, Phoenix, Arizona, United States
Arizona Neurological Institute, Sun City, Arizona, United States
Clinical Research Advantage Inc., Tempe, Arizona, United States
Sutter East Bay Physicians Medical Foundation, Berkeley, California, United States
Neuro-Pain Medical Center, Inc., Fresno, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Collaborative NeuroScience Network, Inc., Long Beach, California, United States
University of California Davis Medical Center, Sacramento, California, United States
Mount Sinai Rehabilitation Hospital, Hartford, Connecticut, United States
Georgetown University Hospital, Washington, District of Columbia, United States
Neurology Associates, PA, Maitland, Florida, United States
University of Miami School of Medicine, Dept. of Neurology, Miami, Florida, United States
Neurological Associates, Pompano Beach, Florida, United States
Neurologique Foundation, Inc., Ponte Vedra, Florida, United States
Suncoast Neuroscience Associates, Inc., Saint Petersburg, Florida, United States
Negroski, Sutherland and Hanes Neurology, Sarasota, Florida, United States
Tallahassee Neurological Clinic, PA, Tallahassee, Florida, United States
Axiom Clinical Research of Florida, Tampa, Florida, United States
The Multiple Sclerosis Center of Vero Beach, Vero Beach, Florida, United States
Sheperd Center, Inc., Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Consultants in Neurology Ltd., Northbrook, Illinois, United States
Indiana University School of Medicine, Indianapolis, Indiana, United States
Josephson Wallack Munshower Neurology, PC, Indianapolis, Indiana, United States
Methodist Plaza Specialty, Des Moines, Iowa, United States
Ruan Neurology Clinic and Research Center, Des Moines, Iowa, United States
The University of Kansas Medical Center, Kansas City, Kansas, United States
Associates in Neurology, PSC, Lexington, Kentucky, United States
University of Maryland, Maryland Center for Multiple Sclerosis, Baltimore, Maryland, United States
Lahey Clinic, Lexington, Massachusetts, United States
Springfield Neurology Associates, LLC, Springfield, Massachusetts, United States
Wayne State University, Detroit, Michigan, United States
Advanced Neurology Specialists, Great Falls, Montana, United States
Veterans Administration Sierra Neveda Health Care System, Reno, Nevada, United States
Upstate Clinical Research, LLC, Albany, New York, United States
NYU Langone Medical Center MS Comprehensive Care Center, New York, New York, United States
Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, Patchogue, New York, United States
Island Neurological Associates, PC, Plainview, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
PMG Research of Charlotte, Charlotte, North Carolina, United States
The Neurological Institute, PA, Charlotte, North Carolina, United States
PMG Research of Hickory, LLC, Hickory, North Carolina, United States
Raleigh Neurology Associates, Raleigh, North Carolina, United States
PMG Research of Winston-Salem, Winston-Salem, North Carolina, United States
Altru Health System Clinic, Grand Forks, North Dakota, United States
Northern Ohio Neuroscience, LLC, Bellevue, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Neurological Research Institute, Columbus, Ohio, United States
Ohio State University, Columbus, Columbus, Ohio, United States
Neurology Specialists, Inc., Dayton, Ohio, United States
OMRF Multiple Sclerosis Center of Excellence, Oklahoma City, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
Providence Multiple Sclerosis Center, Portland, Oregon, United States
The Pennsylvania State University, Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Temple University School of Medicine, Philadelphia, Pennsylvania, United States
The Neurology Foundation, Inc., Providence, Rhode Island, United States
Wesley Neurology Clinic, PC, Cordova, Tennessee, United States
Advanced Neurosciences Institute, Franklin, Tennessee, United States
Sibyl E. Wray, MD, Neurology, PC, Knoxville, Tennessee, United States
Texas Neurology, PA, Dallas, Texas, United States
Kelsey-Seybold Clinic, Houston, Texas, United States
Maxine Mesinger Multiple Sclerosis Clinic; Baylor College of Medicine, Houston, Texas, United States
Fletcher Allen Health Care, Burlington, Vermont, United States
Hampton Roads Neurology, Newport News, Virginia, United States
Neurological Associates, Richmond, Virginia, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Swedish Neuroscience Institute, Seattle, Washington, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Additional Information
Starting date: March 2011
Last updated: September 3, 2013
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