Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01328379
• Date of registration: 29/03/2011
• Prospective Registration: No
• Primary sponsor: Acorda Therapeutics
• Public title: Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis
• Scientific 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
• Date of first enrolment: March 2011
• Target sample size: 430
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01328379
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Matthew Roller, MD
• Affiliation: Altru Health System Research Center

• Name: Jatin Shah, MD
• Affiliation: Arizona Neurological Institute

• Name: Michael Rossen, MD, PhD
• Affiliation: Springfield Neurology Associates, LLC

• Name: Francois Bethoux, MD
• Affiliation: The Cleveland Clinic

• Name: William Sheremata, MD
• Affiliation: University of Miami School of Medicine, Dept. of Neurology

• Name: Jane Chan, MD
• Affiliation: Veterans Administration Medical Center

• Name: Dennis Dietrich, MD
• Affiliation: Advanced Neurology Specialists

• Name: George Hutton, MD
• Affiliation: Maxine Mesinger Multiple Sclerosis Clinic; Baylor College of Medicine

• Name: Joy Derwenskus, DO
• Affiliation: Northwestern University

• Name: Steven Freedman, MD
• Affiliation: Raleigh Neurology Associates

• Name: Sibyl E Wray, MD
• Affiliation: Sibyl E. Wray, MD, Neurology, PC

• Name: Mark Agius, MD
• Affiliation: University of California, Davis

• Name: Kiren Kresa-Reahl, MD
• Affiliation: Charleston Area Medical Center Health Education and Research Institute, Inc.

• Name: Mark Gudesblatt, MD
• Affiliation: Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

• Name: Daniel Wynn, MD
• Affiliation: Consultants in Neurology Ltd.

• Name: Carlo Tornatore, MD
• Affiliation: Georgetown University Hospital

• Name: Craig Herrman, MD
• Affiliation: Josephson Wallack Munshower Neurology, PC

• Name: Lawrence Goldstick, MD
• Affiliation: Neurology Specialists, Inc.

• Name: James S Shafer, MD
• Affiliation: The Multiple Sclerosis Center of Vero Beach

• Name: Christopher Bever, Jr., MD
• Affiliation: University of Maryland, Maryland Center for Multiple Sclerosis

• Name: James Storey, Jr, MD
• Affiliation: Upstate Clinical Research, LLC

• Name: Joanna Cooper, MD
• Affiliation: Alta Bates Summit Medical Center

• Name: Gabriel Pardo, MD
• Affiliation: Mercy Multiple Sclerosis Center of Oklahoma Mercy Neuroscience Institute

• Name: Adam DiDio, MD
• Affiliation: Suncoast Neuroscience Associates, Inc.

• Name: S. A Azizi, MD, PhD
• Affiliation: Temple University Hospital

• Name: Dina Jacobs, MD
• Affiliation: University of Pennsylvania

• Name: Omar Khan, MD
• Affiliation: Wayne State University

• Name: Samuel Hunter, MD, PhD
• Affiliation: Advanced Neurosciences Institute

• Name: Ann Camac, MD
• Affiliation: Lahey Clinic

• Name: William Honeycutt, MD
• Affiliation: Neurology Associates, PA

• Name: Rekha Pillai, MD
• Affiliation: Neurology Clinic, PC

• Name: Michele Mass, MD
• Affiliation: Oregon Health and Science University

• Name: Bhupendra Khatri, MD
• Affiliation: Aurora Saint Luke's Medical Center

• Name: K A Lloyd, MD
• Affiliation: Hampton Roads Neurology

• Name: David Mattson, MD, PhD
• Affiliation: Indiana University

• Name: Todd Janus, MD, PhD
• Affiliation: Iowa Health Des Moines

• Name: Stephen Newman, MD
• Affiliation: Island Neurological Associates, PC

• Name: Daniel Giang, MD
• Affiliation: Loma Linda University Medical Center

• Name: Christopher LaGanke, MD
• Affiliation: North Central Neurology Associates, PC

• Name: Aaron Boster, MD
• Affiliation: Ohio State University, Columbus

• Name: Andrew R. Blight, PhD
• Affiliation: Acorda Therapeutics

• Name: Mark Cascione, MD
• Affiliation: Axiom Clinical Research of Florida

• Name: Donald Negroski, MD
• Affiliation: Negroski, Stein, Sutherland and Hanes Neurology

• Name: Alan Schulman, MD
• Affiliation: Neurological Associates

• Name: Brian Steingo, MD
• Affiliation: Neurological Associates

• Name: Geoffery Eubank, MD
• Affiliation: Neurological Research Institute

• Name: Syed Rizvi, MD
• Affiliation: Rhode Island Hospital

• Name: Bruce Hughes, MD
• Affiliation: Ruan Neurology Clinical Research Center

• Name: C. Fish Greenfield, MD
• Affiliation: Texas Neurology, PA

• Name: Robert Yapundich, MD
• Affiliation: Unifour Medical Research, LLC

• Name: Angela Applebee, MD
• Affiliation: University of Vermont Medical Center

• Name: Warren Chumley, MD
• Affiliation: Associates in Neurology, PSC

• Name: Eric Borresen, MD
• Affiliation: Metrolina Medical Research

• Name: Barry Hendin, MD
• Affiliation: Phoenix Neurological Associates, LTD

• Name: Ben Thrower, MD
• Affiliation: Shepherd Center, Inc.

• Name: Angeli Mayadev, MD
• Affiliation: Swedish Neuroscience Institute

• Name: T. Hemanth Rao, MD
• Affiliation: The Neurological Institute, PA

• Name: Anthony Turel, Jr, MD
• Affiliation: The Pennsylvania State University, Milton S. Hershey Medical Center

• Name: Sharon Lynch, MD
• Affiliation: The University of Kansas Medical Center

• Name: Andrew Goodman, MD
• Affiliation: University of Rochester

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Other: Placebo

Drug: Dalfampridine-ER 5mg

Drug: Dalfampridine-ER 10mg

Primary Outcome(s)

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)]

Secondary Outcome(s)

Change From Baseline in Six-Minute Walk Distance at Visit 2 [Time Frame: Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )]

Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3 [Time Frame: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)]

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). [Time Frame: Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4)]

Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3. [Time Frame: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)]

Change From Baseline in MSWS-12 at Visit 2 [Time Frame: Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )]

Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3. [Time Frame: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)]

Secondary ID(s)

DER-401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/08/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01328379