Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)

NCT02166346 | Completed Phase 2 Results DMC

• 1 other identifier: NA_00090799
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Transverse myelitis (TM) is an inflammatory disorder of the spinal cord that leads to disabilities of gait. Dalfampridine, a sustained-release potassium inhibitor has been shown to be effective in improving gait and other neurologic functions in multiple sclerosis. Dalfampridine has the potential to improve neurologic function in patients with transverse myelitis as this rare disorder shares a similar pathogenic process with multiple sclerosis. The in a clinical trial to test the efficacy of dalfampridine in TM. The clinical trial that the investigators propose to conduct will focus on TM and will evaluate the dalfampridine in primary neurologic outcome, 25-foot timed walk, and several secondary outcomes including valid behavioral and neurophysiological tests. This is a re-launch of the previous trial, which now includes additional behavioral and clinical testing.

Conditions

Transverse Myelitis; Neuromyelitis Optica; Idiopathic Transverse Myelitis; Myelitis NOS

Keywords

Transverse myelitis

Outcome Measures

Primary Outcomes (1)

• Walking Speed During Timed 25-foot Walk

  In this cross-over study, walking speed was recorded 4 times for each subject while in both the dalfampridine and placebo arms. The results average all of the times while on damfampridine and compares them to the average of the times while on placebo.

  Every 2 weeks during each 8 week intervention

Secondary Outcomes (1)

• Upper and Lower Extremity Muscle Strength Measurements

  baseline and end (8 weeks) of each intervention

Study Arms (2)

Dalfampridine then Placebo

EXPERIMENTAL

All subjects were randomized for the first double-blinded 8-week part of the study to the dalfampridine group. Then subjects were crossed over to the placebo arm for another 8 weeks.

Drug: Dalfampridine; Drug: Placebo

Placebo the Dalfampridine

EXPERIMENTAL

All subjects were randomized for the first double-blinded 8-week part of the study to the placebo arm. Then subjects were crossed over to the dalfampridine arm for another 8 weeks.

Drug: Dalfampridine; Drug: Placebo

Interventions

Dalfampridine DRUG

Dalfampridine 10 mg twice daily for 8 weeks

Also known as: Ampyra

Dalfampridine then Placebo; Placebo the Dalfampridine

Placebo DRUG

Placebo pill 1 tablet twice daily for 8 weeks

Also known as: Sugar pill

Dalfampridine then Placebo; Placebo the Dalfampridine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of transverse myelitis confirmed by MRI
• Gait impairment defined as a baseline timed 25-foot walk of at least 5 seconds and no more than 60 seconds.
• Age 18-70.

You may not qualify if:

• Diagnosis of any of the following concurrent conditions: spinal dural arteriovenous malformation, multiple sclerosis, infectious myelitis and recurrent transverse myelitis of any etiology. Subjects with a positive NMO-Immunoglobulin G (IgG) biomarker test will be permitted to join the study as long as the there is only a history of monophasic, and not recurrent, TM.
• History of seizure(s).
• Pregnancy or positive pregnancy test (mandatory test for all women aged 18-55 to be done at first screening visit).
• Known use or allergy to dalfampridine or any other formulation of 4-aminopyridine.
• Patients unable to walk.
• Patients with history of severe alcohol or drug abuse, severe psychiatric illness such as severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
• Patients with severe uncontrolled medical problems (e.g. hypertension, cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, claudication, uncontrolled epilepsy or others).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Acorda Therapeutics: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Myelitis, Transverse; Neuromyelitis Optica; Myelitis

Interventions

4-Aminopyridine; Sugars

Condition Hierarchy (Ancestors)

Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Demyelinating Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Autoimmune Diseases; Immune System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Michael Levy, Principal Investigator
• Organization: Johns Hopkins University

mlevy@jhmi.edu

443-287-4412

Study Officials

• Michael Levy, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 18, 2014
• Study Start: February 1, 2014
• Primary Completion: January 8, 2017
• Study Completion: January 8, 2017
• Last Updated: April 17, 2018
• Results First Posted: April 17, 2018

Record last verified: 2018-03

Locations

US (1)