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Multiple SclerosisPhase 3NCT01328379

Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis

A Phase 3 study testing Dalfampridine-ER 5mg and Dalfampridine-ER 10mg in people with Multiple Sclerosis, run by Acorda Therapeutics at 70 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Dalfampridine-ER 5mg and Dalfampridine-ER 10mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
430 participants
Where
70 sitesUnited States
Study dates
Mar 2011to Jul 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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Ampyra® or dalfampridine (fampridine or 4 aminopyridine; 4-AP) in any formulation (including compounded), must have withdrawn from the drug for at least one month prior to the Screening Visit.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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

70 sites in 1 country.

70 sites in 1 country

United States70 sites

  • Upstate Clinical Research, LLC

    Albany, New York

  • Sheperd Center, Inc.

    Atlanta, Georgia

  • University of Maryland, Maryland Center for Multiple Sclerosis

    Baltimore, Maryland

  • Northern Ohio Neuroscience, LLC

    Bellevue, Ohio

  • Sutter East Bay Physicians Medical Foundation

    Berkeley, California

  • Fletcher Allen Health Care

    Burlington, Vermont

  • PMG Research of Charlotte

    Charlotte, North Carolina

  • The Neurological Institute, PA

    Charlotte, North Carolina

  • Northwestern University

    Chicago, Illinois

  • Cleveland Clinic Foundation

    Cleveland, Ohio

  • Neurological Research Institute

    Columbus, Ohio

  • Ohio State University, Columbus

    Columbus, Ohio

  • Wesley Neurology Clinic, PC

    Cordova, Tennessee

  • North Central Neurology Associates, PC

    Cullman, Alabama

  • Texas Neurology, PA

    Dallas, Texas

  • Neurology Specialists, Inc.

    Dayton, Ohio

  • Methodist Plaza Specialty

    Des Moines, Iowa

  • Ruan Neurology Clinic and Research Center

    Des Moines, Iowa

  • Wayne State University

    Detroit, Michigan

  • Advanced Neurosciences Institute

    Franklin, Tennessee

  • Neuro-Pain Medical Center, Inc.

    Fresno, California

  • Altru Health System Clinic

    Grand Forks, North Dakota

  • Advanced Neurology Specialists

    Great Falls, Montana

  • Mount Sinai Rehabilitation Hospital

    Hartford, Connecticut

  • The Pennsylvania State University, Milton S. Hershey Medical Center

    Hershey, Pennsylvania

  • PMG Research of Hickory, LLC

    Hickory, North Carolina

  • Kelsey-Seybold Clinic

    Houston, Texas

  • Maxine Mesinger Multiple Sclerosis Clinic; Baylor College of Medicine

    Houston, Texas

  • Indiana University School of Medicine

    Indianapolis, Indiana

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana

  • The University of Kansas Medical Center

    Kansas City, Kansas

  • Sibyl E. Wray, MD, Neurology, PC

    Knoxville, Tennessee

  • Associates in Neurology, PSC

    Lexington, Kentucky

  • Lahey Clinic

    Lexington, Massachusetts

  • Loma Linda University Medical Center

    Loma Linda, California

  • Collaborative NeuroScience Network, Inc.

    Long Beach, California

  • Neurology Associates, PA

    Maitland, Florida

  • University of Miami School of Medicine, Dept. of Neurology

    Miami, Florida

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin

  • NYU Langone Medical Center MS Comprehensive Care Center

    New York, New York

  • Hampton Roads Neurology

    Newport News, Virginia

  • Consultants in Neurology Ltd.

    Northbrook, Illinois

  • OMRF Multiple Sclerosis Center of Excellence

    Oklahoma City, Oklahoma

  • Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates

    Patchogue, New York

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania

  • Temple University School of Medicine

    Philadelphia, Pennsylvania

  • Phoenix Neurological Associates, Ltd

    Phoenix, Arizona

  • Island Neurological Associates, PC

    Plainview, New York

  • Neurological Associates

    Pompano Beach, Florida

  • Neurologique Foundation, Inc.

    Ponte Vedra, Florida

  • Oregon Health and Science University

    Portland, Oregon

  • Providence Multiple Sclerosis Center

    Portland, Oregon

  • The Neurology Foundation, Inc.

    Providence, Rhode Island

  • Raleigh Neurology Associates

    Raleigh, North Carolina

  • Veterans Administration Sierra Neveda Health Care System

    Reno, Nevada

  • Neurological Associates

    Richmond, Virginia

  • Virginia Commonwealth University

    Richmond, Virginia

  • University of Rochester Medical Center

    Rochester, New York

  • University of California Davis Medical Center

    Sacramento, California

  • Negroski, Sutherland and Hanes Neurology

    Sarasota, Florida

  • Swedish Neuroscience Institute

    Seattle, Washington

  • Springfield Neurology Associates, LLC

    Springfield, Massachusetts

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida

  • Arizona Neurological Institute

    Sun City, Arizona

  • Tallahassee Neurological Clinic, PA

    Tallahassee, Florida

  • Axiom Clinical Research of Florida

    Tampa, Florida

  • Clinical Research Advantage Inc.

    Tempe, Arizona

  • The Multiple Sclerosis Center of Vero Beach

    Vero Beach, Florida

  • Georgetown University Hospital

    Washington D.C., District of Columbia

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Dalfampridine-ER 5mg, Dalfampridine-ER 10mg, Placebo
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dalfampridine-ER 5mgDrug

    Also called Fampridine, Dalfampridine, Ampyra

    5mg, twice daily

  • Dalfampridine-ER 10mgDrug

    Also called Fampridine, Dalfampridine, Ampyra

    10mg, twice daily

  • PlaceboOther

    placebo, twice daily

Study groups in NCT01328379
Study groupRoleWhat they receive
Dalfampridine-ER 5mgActive comparator5mg, twice daily
Receives: Drug: Dalfampridine-ER 5mg
Dalfampridine-ER 10mgActive comparator10mg, twice daily
Receives: Drug: Dalfampridine-ER 10mg
PlaceboPlacebo comparatorplacebo, twice daily
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability.

    A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study.

    Measured: Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4)

Secondary outcomes (6)

  1. 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).

    The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability.

    A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study.

    Measured: Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4)

  2. Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3

    The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.

    For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.

    MSWS-12 Score = 100 * [(Sum of Items 1-12) - 12]/48

    Measured: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)

  3. Change From Baseline in MSWS-12 at Visit 2

    The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.

    For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.

    MSWS-12 Score = 100 * [(Sum of Items 1-12) - 12]/48

    Measured: Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )

  4. Change From Baseline in Six-Minute Walk Distance at Visit 2

    The Six-Minute Walk, a test of endurance, measures the distance that a patient can walk in a period of 6 minutes. Six-minute walk distance will be reported in feet.

    Measured: Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )

  5. Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3.

    Patients completed a brief, generic health status questionnaire: The five specific dimensional scores value patients' health related to mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each question has 3 distinguishable choices that can be analyzed using a 3-point scale (i.e. 1 = no problem, 2=some problems and 3= extreme problems).

    A response of 1 indicates that the patient has no problem with the dimension tested and a response of 3 indicates that the patient has extreme problems with the dimension tested. For each visit, the average score of 5 dimensions was calculated by averaging the scores of 5 dimensions. EQ-5D final score ranges from 1-3.

    Measured: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)

  6. Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3.

    The EQ-5D is a brief questionnaire that asks patients to rate general state of health. The VAS score rates the general state of health of a patient with 100 for the best imaginable health state and 0 for the worst imaginable health state.

    Measured: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionApr 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328379
Sponsor's protocol ID
DER-401
Status last verified
Sep 2013
First submitted
29 Mar 2011
Last updated
5 Sep 2013
Data monitoring committee
Yes

Publications

  • Applebee A, Goodman AD, Mayadev AS, Bethoux F, Goldman MD, Klingler M, Blight AR, Carrazana EJ. Effects of Dalfampridine Extended-release Tablets on 6-minute Walk Distance in Patients With Multiple Sclerosis: A Post Hoc Analysis of a Double-blind, Placebo-controlled Trial. Clin Ther. 2015 Dec 1;37(12):2780-7. doi: 10.1016/j.clinthera.2015.10.014. Epub 2015 Nov 10.

    PubMed 26565077

  • Kantor D, Chancellor MB, Snell CW, Henney HR 3rd, Rabinowicz AL. Assessment of confirmed urinary tract infection in patients treated with dalfampridine for multiple sclerosis. Postgrad Med. 2015 Mar;127(2):218-22. doi: 10.1080/00325481.2015.1000229. Epub 2015 Jan 6.

    PubMed 25560174

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dalfampridine-ER 5mg and Dalfampridine-ER 10mg in people with Multiple Sclerosis, run by Acorda Therapeutics at 70 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01328379, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.

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