Trial · NCT01683838

Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury

NCT01683838, Phase 3, Completed, Acorda Therapeutics; results first posted 2014-02-05

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury. Trials, record NCT01683838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01683838

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Trial

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

Title: Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
NCT number: NCT01683838
Status: Completed
Phases: Phase 3
Enrollment: 204 participants, actual
Lead sponsor: Acorda Therapeutics
Conditions: Spinal Cord Injury, Muscle Spasticity
Interventions: Fampridine-SR, Placebo
First posted: 2012-09-12
Last updated: 2017-08-25
Results first posted: 2014-02-05

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity	Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98	The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale: 1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension. The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.
Primary	Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores	Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98	The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome. The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.
Secondary	Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores	Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98	The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms. The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report. On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores.
Secondary	Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores	Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)	The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.
Secondary	Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score	Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98	Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.
Secondary	Change From Baseline in Mean International Index of Erectile Function (IIEF) Score	Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98	Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction. Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement.
Secondary	Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores	Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98	The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never). A positive change signifies improvement.
Secondary	Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores	Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98	Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily. A negative change in patient bladder/bowel function diary score signifies improvement.
Secondary	Adjusted Mean Change in Subject Bowel Function Diary Scores	Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98	Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily. A negative change in patient bowel function diary score signifies improvement.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity	Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98	Intent to Treat (ITT) Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.	units on a scale	MEAN
PRIMARY	Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores	Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98	ITT population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.	units on a scale	MEAN
SECONDARY	Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores	Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98	ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.	units on a scale	MEAN
SECONDARY	Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores	Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)	ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.	units on a scale	MEAN
SECONDARY	Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score	Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98	ITT Population. Number of participants analyzed is number of patients with available data at both baseline and stable-blind treatment period.	units on a scale	MEAN
SECONDARY	Change From Baseline in Mean International Index of Erectile Function (IIEF) Score	Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98	ITT Population. N = number of participants analyzed with available data at both baseline and stable treatment period.	units on a scale	MEAN
SECONDARY	Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores	Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98		units on a scale	MEAN
SECONDARY	Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores	Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98	ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.	episodes	MEAN
SECONDARY	Adjusted Mean Change in Subject Bowel Function Diary Scores	Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98	ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.	minutes	MEAN

Source ClinicalTrials.gov

Results by group44

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

Outcome	Group	Category	Value	Spread	Units
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity	Fampridine-SR 50mg/Day		-0.28	Standard Error 0.046	units on a scale
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity	Placebo		-0.16	Standard Error 0.047	units on a scale
Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores	Fampridine-SR 50mg/Day		-0.0	Standard Error 0.07	units on a scale
Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores	Placebo		0.1	Standard Error 0.08	units on a scale
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores	Fampridine-SR 50mg/Day	Arm Spasm Frequency	-0.13	Standard Error 0.051	units on a scale
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores	Placebo	Arm Spasm Frequency	0.02	Standard Error 0.053	units on a scale
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores	Fampridine-SR 50mg/Day	Leg Spasm Frequency	-0.12	Standard Error 0.051	units on a scale
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores	Placebo	Leg Spasm Frequency	-0.10	Standard Error 0.052	units on a scale
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores	Fampridine-SR 50mg/Day	Arm Spasm Severity	-0.09	Standard Error 0.034	units on a scale
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores	Placebo	Arm Spasm Severity	-0.02	Standard Error 0.035	units on a scale

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Fampridine-SR 50mg/Day	104
Overall Study	STARTED	Placebo	100
Overall Study	Intent to Treat (ITT) Population	Fampridine-SR 50mg/Day	103
Overall Study	Intent to Treat (ITT) Population	Placebo	100
Overall Study	Safety Population	Fampridine-SR 50mg/Day	103
Overall Study	Safety Population	Placebo	100
Overall Study	Efficacy Population	Fampridine-SR 50mg/Day	89
Overall Study	Efficacy Population	Placebo	93
Overall Study	COMPLETED	Fampridine-SR 50mg/Day	78
Overall Study	COMPLETED	Placebo	88

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events168

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	Hypertonia	Psychiatric disorders	Fampridine-SR 50mg/Day	24	103	32
other	Hypertonia	Psychiatric disorders	Placebo	17	100	21
other	Urinary Tract Infection	Infections and infestations	Fampridine-SR 50mg/Day	22	103	33
other	Urinary Tract Infection	Infections and infestations	Placebo	15	100	22
other	Pain	General disorders	Fampridine-SR 50mg/Day	19	103	23
other	Pain	General disorders	Placebo	14	100	15
other	Constipation	Renal and urinary disorders	Fampridine-SR 50mg/Day	19	103	23
other	Constipation	Renal and urinary disorders	Placebo	10	100	12
other	Paresthesia	Nervous system disorders	Fampridine-SR 50mg/Day	18	103	25
other	Paresthesia	Nervous system disorders	Placebo	9	100	11

1 to 10 of 168Source ClinicalTrials.gov

See all 168 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fampridine-SR 50mg/Day
Total, all-cause mortality	Placebo
Total, other adverse events	Fampridine-SR 50mg/Day	24	103
Total, other adverse events	Placebo	17	100
Total, serious adverse events	Fampridine-SR 50mg/Day	8	103
Total, serious adverse events	Placebo	9	100

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
Fampridine-SR 50mg/Day 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.

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