Trial Outcomes & Findings for Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch) (NCT NCT02166346)
NCT ID: NCT02166346
Last Updated: 2018-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Every 2 weeks during each 8 week intervention
Results posted on
2018-04-17
Participant Flow
Participant milestones
| Measure |
Dalfampridine Then Placebo
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
|
Placebo Then Dalfampridine
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
|
|---|---|---|
|
Screening and Randomization
STARTED
|
12
|
12
|
|
Screening and Randomization
COMPLETED
|
8
|
8
|
|
Screening and Randomization
NOT COMPLETED
|
4
|
4
|
|
Intervention - Phase 1
STARTED
|
8
|
8
|
|
Intervention - Phase 1
COMPLETED
|
8
|
6
|
|
Intervention - Phase 1
NOT COMPLETED
|
0
|
2
|
|
Intervention - Phase 2 (After Crossover)
STARTED
|
8
|
6
|
|
Intervention - Phase 2 (After Crossover)
COMPLETED
|
7
|
6
|
|
Intervention - Phase 2 (After Crossover)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)
Baseline characteristics by cohort
| Measure |
Whole Study Population
n=13 Participants
This is a crossover trial. At baseline prior to randomization into an intervention, the baseline measures are provided.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Duration of Disease
|
7.2 years
n=5 Participants
|
|
Expanded Disability Status Scale score
|
4.9 units on a scale
n=5 Participants
|
|
Lesion location within spinal cord
Cervical
|
4 Participants
n=5 Participants
|
|
Lesion location within spinal cord
Cervicothoracic
|
5 Participants
n=5 Participants
|
|
Lesion location within spinal cord
Thoracic
|
4 Participants
n=5 Participants
|
|
Lesion length by MRI
|
6 vertebral lengths
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 2 weeks during each 8 week interventionPopulation: 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.
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.
Outcome measures
| Measure |
Dalfampridine
n=13 Participants
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
n=13 Participants
Placebo controlled arm.
Placebo: Placebo pill 1 tablet twice daily for 8 weeks
|
|---|---|---|
|
Walking Speed During Timed 25-foot Walk
Change from baseline to 2 weeks
|
0.3342 feet/second
Interval 0.0975 to 0.5709
|
0.4745 feet/second
Interval 0.2294 to 0.7195
|
|
Walking Speed During Timed 25-foot Walk
Change from baseline to 4 weeks
|
0.4593 feet/second
Interval 0.2071 to 0.7114
|
0.1743 feet/second
Interval -0.06251 to 0.4111
|
|
Walking Speed During Timed 25-foot Walk
Change from baseline to 6 weeks
|
0.5445 feet/second
Interval 0.1018 to 0.9872
|
0.5697 feet/second
Interval 0.1596 to 0.9799
|
|
Walking Speed During Timed 25-foot Walk
Change from baseline to 8 weeks
|
0.3803 feet/second
Interval -0.0113 to 0.7719
|
0.2101 feet/second
Interval -0.1757 to 0.5959
|
SECONDARY outcome
Timeframe: baseline and end (8 weeks) of each interventionUpper 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.
Outcome measures
| Measure |
Dalfampridine
n=13 Participants
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
n=13 Participants
Placebo controlled arm.
Placebo: Placebo pill 1 tablet twice daily for 8 weeks
|
|---|---|---|
|
Upper and Lower Extremity Muscle Strength Measurements
Supine Left Hip Flexor
|
.6420 Pounds
Interval -7.3278 to 8.6118
|
-0.05187 Pounds
Interval -6.3646 to 6.2609
|
|
Upper and Lower Extremity Muscle Strength Measurements
Supine Right Hip Flexor
|
2.5774 Pounds
Interval -2.4644 to 7.6192
|
2.854 Pounds
Interval -1.31 to 7.018
|
|
Upper and Lower Extremity Muscle Strength Measurements
Prone Left Hip Flexor
|
3.286 Pounds
Interval -6.5985 to 13.1717
|
-1.497 Pounds
Interval -10.053 to 7.0572
|
|
Upper and Lower Extremity Muscle Strength Measurements
Prone Right Hip Flexor
|
3.9752 Pounds
Interval -6.8518 to 14.8022
|
-4.4162 Pounds
Interval -13.7929 to 4.9604
|
|
Upper and Lower Extremity Muscle Strength Measurements
Left Grip
|
3.1594 Pounds
Interval -4.844 to 11.1628
|
-2.9007 Pounds
Interval -10.7863 to 4.9849
|
|
Upper and Lower Extremity Muscle Strength Measurements
Right Grip
|
-1.3602 Pounds
Interval -6.7146 to 3.9942
|
2.1665 Pounds
Interval -3.1048 to 7.4378
|
Adverse Events
Dalfampridine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dalfampridine
n=13 participants at risk
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
n=13 participants at risk
Placebo controlled arm.
Placebo: Placebo pill 1 tablet twice daily for 8 weeks
|
|---|---|---|
|
Renal and urinary disorders
Urinary urgency
|
30.8%
4/13 • Number of events 4
|
38.5%
5/13 • Number of events 5
|
|
Nervous system disorders
Insomnia
|
15.4%
2/13 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13
|
15.4%
2/13 • Number of events 2
|
|
Nervous system disorders
Weakness
|
30.8%
4/13 • Number of events 4
|
15.4%
2/13 • Number of events 2
|
|
Nervous system disorders
Fatigue
|
30.8%
4/13 • Number of events 4
|
30.8%
4/13 • Number of events 4
|
|
Nervous system disorders
Muscle stiffness
|
30.8%
4/13 • Number of events 4
|
38.5%
5/13 • Number of events 5
|
Additional Information
Michael Levy, Principal Investigator
Johns Hopkins University
Phone: 443-287-4412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place