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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

Page last updated: August 20, 2015

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