Trial · NCT01356940

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

NCT01356940, Phase 4, Completed, Brown, Theodore R., M.D., MPH; results first posted 2015-04-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis. Trials, record NCT01356940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01356940

On this page

Trial

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

Title: A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis
NCT number: NCT01356940
Status: Completed
Phases: Phase 4
Enrollment: 43 participants, actual
Lead sponsor: Brown, Theodore R., M.D., MPH
Conditions: Multiple Sclerosis
Interventions: dalfampridine ER, placebo
First posted: 2011-05-20
Last updated: 2018-10-31
Results first posted: 2015-04-09

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Peak Activity Index	10 weeks	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
Secondary	Stepcount	10 weeks	change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks

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	Peak Activity Index	10 weeks		change in strides per minute	MEAN
SECONDARY	Stepcount	10 weeks	total subject population	steps per day	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Peak Activity Index	Dalfampridine ER 10mg Bid	0.6	Standard Deviation 0.54	change in strides per minute
Peak Activity Index	Placebo	0.3	Standard Deviation 0.55	change in strides per minute
Stepcount	Dalfampridine ER vs Baseline	148.7	Standard Deviation 222	steps per day
Stepcount	Placebo vs Baseline	128	Standard Deviation 225	steps per day

Source ClinicalTrials.gov

Participant flow18

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

Period	Milestone	Group	Participants
First Intervention (28 Days)	STARTED	Dalfampridine ER 10mg Bid- Placebo	22
First Intervention (28 Days)	STARTED	Placebo-dalfampridine ER 10mg Bid	21
First Intervention (28 Days)	COMPLETED	Dalfampridine ER 10mg Bid- Placebo	21
First Intervention (28 Days)	COMPLETED	Placebo-dalfampridine ER 10mg Bid	21
First Intervention (28 Days)	NOT COMPLETED	Dalfampridine ER 10mg Bid- Placebo	1
First Intervention (28 Days)	NOT COMPLETED	Placebo-dalfampridine ER 10mg Bid	0
Washout (14 Days)	STARTED	Dalfampridine ER 10mg Bid- Placebo	21
Washout (14 Days)	STARTED	Placebo-dalfampridine ER 10mg Bid	21
Washout (14 Days)	COMPLETED	Dalfampridine ER 10mg Bid- Placebo	21
Washout (14 Days)	COMPLETED	Placebo-dalfampridine ER 10mg Bid	21

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events2

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	worsening balance	Nervous system disorders	Dalfampridine ER 10mg Bid	2	43	2
other	worsening balance	Nervous system disorders	Placebo	0	42	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dalfampridine ER 10mg Bid
Total, all-cause mortality	Placebo
Total, other adverse events	Dalfampridine ER 10mg Bid	2	43
Total, other adverse events	Placebo	0	42
Total, serious adverse events	Dalfampridine ER 10mg Bid	0	43
Total, serious adverse events	Placebo	0	42

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 comparisons1

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

Comparison
Dalfampridine ER 10mg Bid vs Placebo: serious adverse events

Source 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/NCT01356940

GET https://conductscience.org/api/trials/v1/NCT01356940/registered

API reference For AI assistants