Trial · NCT00127530

Study of Oral Fampridine-SR in Multiple Sclerosis

NCT00127530, Phase 3, Completed, Acorda Therapeutics; results first posted 2011-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Oral Fampridine-SR in Multiple Sclerosis. Trials, record NCT00127530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00127530

On this page

Trial

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

Title: Study of Oral Fampridine-SR in Multiple Sclerosis
NCT number: NCT00127530
Status: Completed
Phases: Phase 3
Enrollment: 300 participants, actual
Lead sponsor: Acorda Therapeutics
Conditions: Multiple Sclerosis
Interventions: Fampridine-SR, Placebo
First posted: 2005-08-08
Last updated: 2018-09-11
Results first posted: 2011-05-06

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)	Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.	Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.
Secondary	Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity	Days 14, 42, 70, 98

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	Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)	Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.	ITT Population	Participants	NUMBER
SECONDARY	Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity	Days 14, 42, 70, 98

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)	Placebo- Sugar Pill		6		Participants
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)	Fampridine-SR		78		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo- Sugar Pill	72
Overall Study	STARTED	Fampridine-SR	228
Overall Study	COMPLETED	Placebo- Sugar Pill	71
Overall Study	COMPLETED	Fampridine-SR	207
Overall Study	NOT COMPLETED	Placebo- Sugar Pill	1
Overall Study	NOT COMPLETED	Fampridine-SR	21

Source ClinicalTrials.gov

Adverse events66

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	Musculoskeletal and connective tissue disorders	Placebo- Sugar Pill	4	72	5
other	asthenia	Musculoskeletal and connective tissue disorders	Fampridine-SR	13	228	16
other	back pain	Musculoskeletal and connective tissue disorders	Placebo- Sugar Pill	0	72	0
other	back pain	Musculoskeletal and connective tissue disorders	Fampridine-SR	13	228	14
other	balance disorder	Nervous system disorders	Placebo- Sugar Pill	2	72	2
other	balance disorder	Nervous system disorders	Fampridine-SR	13	228	13
other	dizziness	Nervous system disorders	Placebo- Sugar Pill	4	72	4
other	dizziness	Nervous system disorders	Fampridine-SR	19	228	21
other	fall	Injury, poisoning and procedural complications	Placebo- Sugar Pill	11	72	14
other	fall	Injury, poisoning and procedural complications	Fampridine-SR	36	228	56

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo- Sugar Pill
Total, all-cause mortality	Fampridine-SR
Total, other adverse events	Placebo- Sugar Pill	58	72
Total, other adverse events	Fampridine-SR	191	228
Total, serious adverse events	Placebo- Sugar Pill	0	72
Total, serious adverse events	Fampridine-SR	16	228

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19249634	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 vs Placebo- Sugar Pill: Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)	Trial comparisons
Fampridine-SR vs Placebo- Sugar Pill: 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/NCT00127530

GET https://conductscience.org/api/trials/v1/NCT00127530/events?page=2

API reference For AI assistants