Trial · NCT00483652

Study of Fampridine-SR Tablets in Multiple Sclerosis Patients

NCT00483652, Phase 3, Completed, Acorda Therapeutics; results first posted 2011-04-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Fampridine-SR Tablets in Multiple Sclerosis Patients. Trials, record NCT00483652. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00483652

On this page

Trial

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

Title: Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
NCT number: NCT00483652
Status: Completed
Phases: Phase 3
Enrollment: 240 participants, actual
Lead sponsor: Acorda Therapeutics
Conditions: Multiple Sclerosis
Interventions: Fampridine-SR, Placebo
First posted: 2007-06-07
Last updated: 2016-02-04
Results first posted: 2011-04-14

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Responders Based Upon the Timed 25-Foot Walk [T25FW]	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)
Secondary	Change in Lower Extremity Manual Muscle Test [LEMMT]	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.

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	Responders Based Upon the Timed 25-Foot Walk [T25FW]	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	Modified Intention-to-Treat \[ITT\] population	participants	NUMBER
SECONDARY	Change in Lower Extremity Manual Muscle Test [LEMMT]	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77		units on a scale	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
Responders Based Upon the Timed 25-Foot Walk [T25FW]	Fampridine-SR 10 mg b.i.d. Treatment	51		participants
Responders Based Upon the Timed 25-Foot Walk [T25FW]	Placebo Treatment	11		participants
Change in Lower Extremity Manual Muscle Test [LEMMT]	Fampridine-SR 10 mg b.i.d. Treatment	0.09	Standard Deviation 0.219	units on a scale
Change in Lower Extremity Manual Muscle Test [LEMMT]	Placebo Treatment	0.04	Standard Deviation 0.253	units on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Double-blind Treatment Period	STARTED	Fampridine-SR 10 mg b.i.d. Treatment	120
Double-blind Treatment Period	STARTED	Placebo Treatment	119
Double-blind Treatment Period	COMPLETED	Fampridine-SR 10 mg b.i.d. Treatment	113
Double-blind Treatment Period	COMPLETED	Placebo Treatment	114
Double-blind Treatment Period	NOT COMPLETED	Fampridine-SR 10 mg b.i.d. Treatment	7
Double-blind Treatment Period	NOT COMPLETED	Placebo Treatment	5
Post-study Follow-up	STARTED	Fampridine-SR 10 mg b.i.d. Treatment	113
Post-study Follow-up	STARTED	Placebo Treatment	114
Post-study Follow-up	COMPLETED	Fampridine-SR 10 mg b.i.d. Treatment	113
Post-study Follow-up	COMPLETED	Placebo Treatment	114

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events92

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	Diarrhoea	Gastrointestinal disorders	Fampridine-SR 10 mg b.i.d. Treatment	3	120	3
other	Diarrhoea	Gastrointestinal disorders	Placebo Treatment	3	119	5
other	Nausea	Gastrointestinal disorders	Fampridine-SR 10 mg b.i.d. Treatment	10	120	10
other	Nausea	Gastrointestinal disorders	Placebo Treatment	1	119	1
other	Abdominal discomfort	Gastrointestinal disorders	Fampridine-SR 10 mg b.i.d. Treatment	3	120	3
other	Abdominal discomfort	Gastrointestinal disorders	Placebo Treatment	1	119	1
other	Constipation	Gastrointestinal disorders	Fampridine-SR 10 mg b.i.d. Treatment	3	120	3
other	Constipation	Gastrointestinal disorders	Placebo Treatment	3	119	3
other	Asthenia	General disorders	Fampridine-SR 10 mg b.i.d. Treatment	10	120	10
other	Asthenia	General disorders	Placebo Treatment	5	119	5

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fampridine-SR 10 mg b.i.d. Treatment
Total, all-cause mortality	Placebo Treatment
Total, other adverse events	Fampridine-SR 10 mg b.i.d. Treatment	103	120
Total, other adverse events	Placebo Treatment	79	119
Total, serious adverse events	Fampridine-SR 10 mg b.i.d. Treatment	5	120
Total, serious adverse events	Placebo Treatment	3	119

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20976768	RESULT

Source PubMed

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
Fampridine-SR 10 mg b.i.d. Treatment vs Placebo Treatment: Responders Based Upon the Timed 25-Foot Walk [T25FW]	Trial comparisons
Fampridine-SR 10 mg b.i.d. Treatment vs Placebo Treatment: 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/NCT00483652

GET https://conductscience.org/api/trials/v1/NCT00483652/events?page=2

API reference For AI assistants