Trial · NCT00053417

Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

NCT00053417, Phase 2, Completed, Acorda Therapeutics; results first posted 2011-08-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis. Trials, record NCT00053417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00053417

On this page

Trial

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

Title: Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
NCT number: NCT00053417
Status: Completed
Phases: Phase 2
Enrollment: 206 participants, actual
Lead sponsor: Acorda Therapeutics
Conditions: Multiple Sclerosis
Interventions: Placebo, 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP), 15 mg fampridine-SR (4-aminopyridine, 4-AP), 20 mg fampridine-SR (4-aminopyridine, 4-AP)
First posted: 2003-01-30
Last updated: 2011-08-04
Results first posted: 2011-08-04

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test	Baseline (placebo run-in period); 12-week stable dose period	The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test	Baseline (placebo run-in period); 12-week stable dose period		percent change	MEDIAN

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
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test	Placebo	1.2	Full Range 18.9	percent change
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test	10 mg Fampridine Twice a Day (b.i.d.)	7.5	Full Range 22.1	percent change
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test	15 mg Fampridine b.i.d.	9.7	Full Range 23.7	percent change
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test	20 mg Fampridine b.i.d.	6.9	Full Range 18.5	percent change

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	47
Overall Study	STARTED	10 mg Fampridine Twice a Day (b.i.d.)	52
Overall Study	STARTED	15 mg Fampridine b.i.d.	50
Overall Study	STARTED	20 mg Fampridine b.i.d.	57
Overall Study	COMPLETED	Placebo	45
Overall Study	COMPLETED	10 mg Fampridine Twice a Day (b.i.d.)	50
Overall Study	COMPLETED	15 mg Fampridine b.i.d.	49
Overall Study	COMPLETED	20 mg Fampridine b.i.d.	51
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	10 mg Fampridine Twice a Day (b.i.d.)	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events96

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	Asthenia	General disorders	Placebo	1	47	1
other	Asthenia	General disorders	10 mg Fampridine Twice a Day (b.i.d.)	10	52	11
other	Asthenia	General disorders	15 mg Fampridine b.i.d.	9	50	13
other	Asthenia	General disorders	20 mg Fampridine b.i.d.	3	57	4
other	Balance Disorder	Nervous system disorders	Placebo	0	47	0
other	Balance Disorder	Nervous system disorders	10 mg Fampridine Twice a Day (b.i.d.)	3	52	3
other	Balance Disorder	Nervous system disorders	15 mg Fampridine b.i.d.	4	50	4
other	Balance Disorder	Nervous system disorders	20 mg Fampridine b.i.d.	5	57	5
other	Dizziness	Nervous system disorders	Placebo	5	47	5
other	Dizziness	Nervous system disorders	10 mg Fampridine Twice a Day (b.i.d.)	2	52	4

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	10 mg Fampridine Twice a Day (b.i.d.)
Total, all-cause mortality	15 mg Fampridine b.i.d.
Total, all-cause mortality	20 mg Fampridine b.i.d.
Total, other adverse events	Placebo	38	47
Total, other adverse events	10 mg Fampridine Twice a Day (b.i.d.)	45	52
Total, other adverse events	15 mg Fampridine b.i.d.	47	50
Total, other adverse events	20 mg Fampridine b.i.d.	52	57
Total, serious adverse events	Placebo	2	47
Total, serious adverse events	10 mg Fampridine Twice a Day (b.i.d.)	0	52

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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 comparisons0

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

None in this release.

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/NCT00053417

GET https://conductscience.org/api/trials/v1/NCT00053417/events?page=2

API reference For AI assistants