Trial · NCT02166346

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

NCT02166346, Phase 2, Completed, Johns Hopkins University; results first posted 2018-04-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch). Trials, record NCT02166346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02166346

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)
NCT number: NCT02166346
Status: Completed
Phases: Phase 2
Enrollment: 24 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Transverse Myelitis, Neuromyelitis Optica, Idiopathic Transverse Myelitis, Myelitis NOS
Interventions: Dalfampridine, Placebo
First posted: 2014-06-18
Last updated: 2018-04-17
Results first posted: 2018-04-17

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Walking Speed During Timed 25-foot Walk	Every 2 weeks during each 8 week intervention	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.
Secondary	Upper and Lower Extremity Muscle Strength Measurements	baseline and end (8 weeks) of each intervention	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Walking Speed During Timed 25-foot Walk	Every 2 weeks during each 8 week intervention	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.	feet/second	MEAN
SECONDARY	Upper and Lower Extremity Muscle Strength Measurements	baseline and end (8 weeks) of each intervention		Pounds	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Walking Speed During Timed 25-foot Walk	Dalfampridine	Change from baseline to 2 weeks	0.3342	Full Range 0.0975 to 0.5709	feet/second
Walking Speed During Timed 25-foot Walk	Placebo	Change from baseline to 2 weeks	0.4745	Full Range 0.2294 to 0.7195	feet/second
Walking Speed During Timed 25-foot Walk	Dalfampridine	Change from baseline to 4 weeks	0.4593	Full Range 0.2071 to 0.7114	feet/second
Walking Speed During Timed 25-foot Walk	Placebo	Change from baseline to 4 weeks	0.1743	Full Range -0.06251 to 0.4111	feet/second
Walking Speed During Timed 25-foot Walk	Dalfampridine	Change from baseline to 6 weeks	0.5445	Full Range 0.1018 to 0.9872	feet/second
Walking Speed During Timed 25-foot Walk	Placebo	Change from baseline to 6 weeks	0.5697	Full Range 0.1596 to 0.9799	feet/second
Walking Speed During Timed 25-foot Walk	Dalfampridine	Change from baseline to 8 weeks	0.3803	Full Range -0.0113 to 0.7719	feet/second
Walking Speed During Timed 25-foot Walk	Placebo	Change from baseline to 8 weeks	0.2101	Full Range -0.1757 to 0.5959	feet/second
Upper and Lower Extremity Muscle Strength Measurements	Dalfampridine	Supine Left Hip Flexor	.6420	95% Confidence Interval -7.3278 to 8.6118	Pounds
Upper and Lower Extremity Muscle Strength Measurements	Placebo	Supine Left Hip Flexor	-0.05187	95% Confidence Interval -6.3646 to 6.2609	Pounds

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Screening and Randomization	STARTED	Dalfampridine Then Placebo	12
Screening and Randomization	STARTED	Placebo Then Dalfampridine	12
Screening and Randomization	COMPLETED	Dalfampridine Then Placebo	8
Screening and Randomization	COMPLETED	Placebo Then Dalfampridine	8
Screening and Randomization	NOT COMPLETED	Dalfampridine Then Placebo	4
Screening and Randomization	NOT COMPLETED	Placebo Then Dalfampridine	4
Intervention - Phase 1	STARTED	Dalfampridine Then Placebo	8
Intervention - Phase 1	STARTED	Placebo Then Dalfampridine	8
Intervention - Phase 1	COMPLETED	Dalfampridine Then Placebo	8
Intervention - Phase 1	COMPLETED	Placebo Then Dalfampridine	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Urinary urgency	Renal and urinary disorders	Dalfampridine	4	13	4
other	Urinary urgency	Renal and urinary disorders	Placebo	5	13	5
other	Insomnia	Nervous system disorders	Dalfampridine	2	13	2
other	Insomnia	Nervous system disorders	Placebo	1	13	1
other	Dizziness	Nervous system disorders	Dalfampridine	0	13	0
other	Dizziness	Nervous system disorders	Placebo	2	13	2
other	Weakness	Nervous system disorders	Dalfampridine	4	13	4
other	Weakness	Nervous system disorders	Placebo	2	13	2
other	Fatigue	Nervous system disorders	Dalfampridine	4	13	4
other	Fatigue	Nervous system disorders	Placebo	4	13	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dalfampridine	0	13
Total, all-cause mortality	Placebo	0	13
Total, other adverse events	Dalfampridine	4	13
Total, other adverse events	Placebo	5	13
Total, serious adverse events	Dalfampridine	0	13
Total, serious adverse events	Placebo	0	13

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dalfampridine vs Placebo: deaths from any cause	Trial comparisons
Dalfampridine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02166346

GET https://conductscience.org/api/trials/v1/NCT02166346/registered

API reference For AI assistants