A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis

NCT01356940 | Completed Phase 4 Results

• 1 other identifier: A randomized
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis

Conditions

Multiple Sclerosis

Keywords

Ambulation

Outcome Measures

Primary Outcomes (1)

• Peak Activity Index

  peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention

  10 weeks

Secondary Outcomes (1)

• Stepcount

  10 weeks

Study Arms (2)

dalfampridine ER 10mg bid-placebo

ACTIVE COMPARATOR

4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control

Drug: dalfampridine ER; Drug: placebo

placebo-dalfampridine ER 10mg bid

PLACEBO COMPARATOR

placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid

Drug: dalfampridine ER; Drug: placebo

Interventions

dalfampridine ER DRUG

dalfampridine ER 10mg bid for 4 weeks

Also known as: Ampyra serial number 77948545

dalfampridine ER 10mg bid-placebo; placebo-dalfampridine ER 10mg bid

placebo DRUG

identical placebo tablet administered bid for four weeks

Also known as: Sugar Pill

dalfampridine ER 10mg bid-placebo; placebo-dalfampridine ER 10mg bid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of MS made at least 3 months prior to based McDonald or Proser criteria.
• Age 18-75 years old inclusive.
• Expanded Disability Status Scale (EDS) 0-6.5
• Clinical stability defined as no MS exacerbation or change in disease modifying therapy for 60 days prior to screening.
• Screening 6-minute walking test distance between 50m-500m, inclusive.
• Written informed consent.

You may not qualify if:

• use of 4-aminopyridine within 6 months of screening
• Any contraindication to DER:
• Allergy to DER
• history of seizure disorder or history of EEG showing epileptiform activity
• Renal insufficiency (estimated GFR \< 60.
• Any condition that would exclude 6 minute walking testing:
• Cardiac surgery or myocardial infarction within the last 3 months.
• Severe aortic stenosis or hypertropic cardiomyopathy.
• Pulmonary embolus or infarction in the last 6 months.
• Uncontrolled hypertension by history or by screening or baseline diastolic blood pressure \> 170, or systolic blood pressure \> 105.
• Use of oxygen at home for 24 hours/day or severe lung disease.
• History of ventricular arrhythmia or finding of significant ventricular arrhythmia. atrial arrhythmia or 2nd or 3rd degree heart block on screening ECG.
• Concomitant neurological disease, such as ALS, Parkinson Disease, stroke.
• Hospitalization in the last 6 months for psychiatric illness.
• Alcohol or drug abuse within the past year.

Sponsors & Collaborators

• Brown, Theodore R., M.D., MPH: lead
• Acorda Therapeutics: collaborator

Study Sites (1)

MS Center at Evergreen

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Sugars

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Theodore R. Brown, MD
• Organization: MS Center at Evergreenhealth

trbrown@evergreenhealth.com

425-899-5350

Study Officials

• Theodore R Brown, MD

  EvergreenHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: November 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 31, 2018
• Results First Posted: April 9, 2015

Record last verified: 2018-10

Locations

US (1)