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

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ClinicalTrials.gov Identifier: NCT02166346
Recruitment Status : Completed
First Posted : June 18, 2014
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Transverse Myelitis
Neuromyelitis Optica
Idiopathic Transverse Myelitis
Myelitis NOS
Interventions Drug: Dalfampridine
Drug: Placebo
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dalfampridine Then Placebo Placebo Then Dalfampridine
Hide Arm/Group Description

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.

Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks Placebo: Placebo pill 1 tablet twice daily for 8 weeks

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.

Placebo: Placebo pill 1 tablet twice daily for 8 weeks Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks

Period Title: Screening and Randomization
Started 12 12
Completed 8 8
Not Completed 4 4
Period Title: Intervention - Phase 1
Started 8 8
Completed 8 6
Not Completed 0 2
Period Title: Intervention - Phase 2 (After Crossover)
Started 8 6
Completed 7 6
Not Completed 1 0
Arm/Group Title Whole Study Population
Hide Arm/Group Description This is a crossover trial. At baseline prior to randomization into an intervention, the baseline measures are provided.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
24 participants consented, 8 were excluded = 16 enrolled. Of the 16 enrollees, 3 withdrew = 13 completers.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
55
(33 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  23.1%
White
10
  76.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Duration of Disease  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
7.2
(3 to 31)
Expanded Disability Status Scale score   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 13 participants
4.9
(3.5 to 6)
[1]
Measure Description: In this scale, 0 is normal and 10 is dead. Additional information can be found here: https://www.mstrust.org.uk/a-z/expanded-disability-status-scale-edss
Lesion location within spinal cord  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Cervical
4
  30.8%
Cervicothoracic
5
  38.5%
Thoracic
4
  30.8%
Lesion length by MRI   [1] 
Mean (Full Range)
Unit of measure:  Vertebral lengths
Number Analyzed 13 participants
6
(2 to 13)
[1]
Measure Description: Vertebral length is defined as the number of vertebrae between the top of the T2 hyper intense lesion by MRI and the bottom of the lesion visualized on the middle sagittal section.
1.Primary Outcome
Title Walking Speed During Timed 25-foot Walk
Hide Description 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.
Time Frame Every 2 weeks during each 8 week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalfampridine Placebo
Hide Arm/Group Description:

All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.

Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks

Placebo controlled arm.

Placebo: Placebo pill 1 tablet twice daily for 8 weeks

Overall Number of Participants Analyzed 13 13
Mean (Full Range)
Unit of Measure: feet/second
Change from baseline to 2 weeks
0.3342
(0.0975 to 0.5709)
0.4745
(0.2294 to 0.7195)
Change from baseline to 4 weeks
0.4593
(0.2071 to 0.7114)
0.1743
(-0.06251 to 0.4111)
Change from baseline to 6 weeks
0.5445
(0.1018 to 0.9872)
0.5697
(0.1596 to 0.9799)
Change from baseline to 8 weeks
0.3803
(-0.0113 to 0.7719)
0.2101
(-0.1757 to 0.5959)
2.Secondary Outcome
Title Upper and Lower Extremity Muscle Strength Measurements
Hide Description Upper and lower extremity muscle strength measurements, using a hand held dynamometer, at the beginning and end of each arm. Change in muscle strength between baseline and end (8 weeks) of each intervention are provided.
Time Frame baseline and end (8 weeks) of each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dalfampridine Placebo
Hide Arm/Group Description:

All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.

Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks

Placebo controlled arm.

Placebo: Placebo pill 1 tablet twice daily for 8 weeks

Overall Number of Participants Analyzed 13 13
Mean (95% Confidence Interval)
Unit of Measure: Pounds
Supine Left Hip Flexor
.6420
(-7.3278 to 8.6118)
-0.05187
(-6.3646 to 6.2609)
Supine Right Hip Flexor
2.5774
(-2.4644 to 7.6192)
2.854
(-1.31 to 7.018)
Prone Left Hip Flexor
3.286
(-6.5985 to 13.1717)
-1.497
(-10.053 to 7.0572)
Prone Right Hip Flexor
3.9752
(-6.8518 to 14.8022)
-4.4162
(-13.7929 to 4.9604)
Left Grip
3.1594
(-4.844 to 11.1628)
-2.9007
(-10.7863 to 4.9849)
Right Grip
-1.3602
(-6.7146 to 3.9942)
2.1665
(-3.1048 to 7.4378)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dalfampridine Placebo
Hide Arm/Group Description

All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.

Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks

Placebo controlled arm.

Placebo: Placebo pill 1 tablet twice daily for 8 weeks

All-Cause Mortality
Dalfampridine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dalfampridine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dalfampridine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/13 (30.77%)      5/13 (38.46%)    
Nervous system disorders     
Insomnia *  2/13 (15.38%)  2 1/13 (7.69%)  1
Dizziness *  0/13 (0.00%)  0 2/13 (15.38%)  2
Weakness *  4/13 (30.77%)  4 2/13 (15.38%)  2
Fatigue *  4/13 (30.77%)  4 4/13 (30.77%)  4
Muscle stiffness *  4/13 (30.77%)  4 5/13 (38.46%)  5
Renal and urinary disorders     
Urinary urgency *  4/13 (30.77%)  4 5/13 (38.46%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Levy, Principal Investigator
Organization: Johns Hopkins University
Phone: 443-287-4412
EMail: mlevy@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02166346     History of Changes
Obsolete Identifiers: NCT01446575
Other Study ID Numbers: NA_00090799
First Submitted: June 16, 2014
First Posted: June 18, 2014
Results First Submitted: January 12, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018