Trial · NCT02219932

Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

NCT02219932, Phase 3, Completed, Biogen; results first posted 2017-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis. Trials, record NCT02219932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02219932

On this page

Trial

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

Title: Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
NCT number: NCT02219932
Status: Completed
Phases: Phase 3
Enrollment: 646 participants, actual
Lead sponsor: Biogen
Conditions: Multiple Sclerosis
Interventions: fampridine, Placebo
First posted: 2014-08-19
Last updated: 2017-03-27
Other registries' IDs: eudract:2013-003600-40
Results first posted: 2017-03-27

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks	Baseline to 24 weeks	MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking. A responder is defined as a participant with a mean improvement of at least 8 points over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. If a participant has a mean MSWS-12 score of \< 0.5 over the double-blind period, and a baseline MSWS-12 score of \< 8 points, the participant is counted as a responder. A participant who indicates they cannot walk at all on MSWS-12 during any double-blind visit, and who shows severe disability and an inability to walk on other efficacy assessments is counted as a non-responder. Estimated proportion obtained from binomial proportions.
Secondary	Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks	Baseline to Week 24	TUG is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm \[18in\], arm height 65 cm \[25.6 in\]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down. A responder is defined as a participant with a mean improvement of at least 15% in TUG speed over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. Estimated proportion obtained from binomial proportions. There are 2 TUG tests given, and the average across the 2 tests is used to calculate average speed. Healthy participants below the age of 79 are expected to complete this task in 7-10 seconds (American College of Rheumatology). Missing data are handled using multiple imputation and baseline is defined as the mean over Screening and Day 1.
Secondary	Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks	Baseline to Week 24	The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 (no impact of MS) to 100 (extreme impact of MS); a negative change indicates an improvement in function. Data are based on a mixed model for repeated measures (MMRM) model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline MSIS-29 physical score and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the mean over screening and Day 1.
Secondary	Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks	Baseline to Week 24	The BBS is a widely used assessment tool to identify balance impairment. Functional activities such as reaching, bending, transferring, and standing are evaluated on the test to evaluate balance. Participants are asked to complete 14 tasks that are rated from 0 (cannot perform) to 4 (normal performance) for a total of 56 points. BBS scores range from 0 (poor balance) to 56 (good balance); a positive change indicates improvement. Data are based on an MMRM model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline BBS and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the mean over screening and Day 1.
Secondary	Change From Baseline in ABILHAND Score Over 24 Weeks	Baseline to Week 24	The ABILHAND Questionnaire measures a participant's perceived difficulty in performing everyday manual activities in the last 3 months. The participant completes a 56-item questionnaire by estimating their own difficulty or ease in performing each of 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 (poor manual ability) to 100 (good manual ability); a positive change indicates an improvement in manual ability. Data are based on an MMRM model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline ABILHAND and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the Day 1 assessment.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks	Baseline to 24 weeks	Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks	Baseline to Week 24	Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.	proportion of participants	NUMBER
SECONDARY	Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks	Baseline to Week 24	Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks	Baseline to Week 24	Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in ABILHAND Score Over 24 Weeks	Baseline to Week 24	Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment and available data.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks	Placebo	0.336		proportion of participants
Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks	Fampridine 10 mg BID	0.432		proportion of participants
Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks	Placebo	0.347		proportion of participants
Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks	Fampridine 10 mg BID	0.434		proportion of participants
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks	Placebo	-4.68	Standard Error 0.936	units on a scale
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks	Fampridine 10 mg BID	-8.00	Standard Error 0.911	units on a scale
Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks	Placebo	1.34	Standard Error 0.284	units on a scale
Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks	Fampridine 10 mg BID	1.75	Standard Error 0.278	units on a scale
Change From Baseline in ABILHAND Score Over 24 Weeks	Placebo	0.75	Standard Error 0.593	units on a scale
Change From Baseline in ABILHAND Score Over 24 Weeks	Fampridine 10 mg BID	1.49	Standard Error 0.574	units on a scale

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	319
Overall Study	STARTED	Fampridine 10 mg BID	317
Overall Study	Randomized, Not Treated	Placebo	0
Overall Study	Randomized, Not Treated	Fampridine 10 mg BID	1
Overall Study	COMPLETED	Placebo	254
Overall Study	COMPLETED	Fampridine 10 mg BID	266
Overall Study	NOT COMPLETED	Placebo	65
Overall Study	NOT COMPLETED	Fampridine 10 mg BID	51

Source ClinicalTrials.gov

Adverse events64

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
other	Nasopharyngitis	Infections and infestations	Placebo	18	319
other	Nasopharyngitis	Infections and infestations	Fampridine 10mg BID	15	316
other	Urinary tract infection	Infections and infestations	Placebo	29	319
other	Urinary tract infection	Infections and infestations	Fampridine 10mg BID	40	316
other	Fall	Injury, poisoning and procedural complications	Placebo	17	319
other	Fall	Injury, poisoning and procedural complications	Fampridine 10mg BID	22	316
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	11	319
other	Back pain	Musculoskeletal and connective tissue disorders	Fampridine 10mg BID	16	316
other	Multiple sclerosis relapse	Nervous system disorders	Placebo	31	319
other	Multiple sclerosis relapse	Nervous system disorders	Fampridine 10mg BID	31	316

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Fampridine 10mg BID
Total, other adverse events	Placebo	93	319
Total, other adverse events	Fampridine 10mg BID	100	316
Total, serious adverse events	Placebo	21	319
Total, serious adverse events	Fampridine 10mg BID	25	316

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30535670	DERIVED

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 comparisons1

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

Comparison
Fampridine 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/NCT02219932

GET https://conductscience.org/api/trials/v1/NCT02219932/events?page=2

API reference For AI assistants