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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fampridine
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Fampridine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria [McDonald 2001; Polman 2005] as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration
  • Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive
  • Must have walking impairment, as deemed by the Investigator

Key Exclusion Criteria:

  • History of human immunodeficiency virus (HIV)
  • Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation
  • Known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet
  • Creatinine clearance (CrCl) of <80 mL/min
  • History of malignant disease
  • Presence of pulmonary disease
  • A body mass index (BMI) ≥40 (BMI formula: BMI = mass [kg]/[height(m)]2)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fampridine 10 mg BID

Placebo

Arm Description

Prolonged-release fampridine 10 mg twice daily (BID) for up to 24 weeks

Matched placebo 10 mg BID for up to 24 weeks

Outcomes

Primary Outcome Measures

Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 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 Outcome Measures

Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks
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.
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks
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.
Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks
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.
Change From Baseline in ABILHAND Score Over 24 Weeks
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.

Full Information

First Posted
August 18, 2014
Last Updated
February 6, 2017
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02219932
Brief Title
Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
Acronym
ENHANCE
Official Title
A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects With Multiple Sclerosis (ENHANCE)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period. The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Fampridine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
646 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fampridine 10 mg BID
Arm Type
Experimental
Arm Description
Prolonged-release fampridine 10 mg twice daily (BID) for up to 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo 10 mg BID for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
fampridine
Other Intervention Name(s)
dalfampridine, Ampyra, Fampyra, fampridine prolonged-release tablets, BIIB041
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo
Primary Outcome Measure Information:
Title
Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks
Description
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.
Time Frame
Baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks
Description
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.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks
Description
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.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks
Description
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.
Time Frame
Baseline to Week 24
Title
Change From Baseline in ABILHAND Score Over 24 Weeks
Description
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.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria [McDonald 2001; Polman 2005] as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive Must have walking impairment, as deemed by the Investigator Key Exclusion Criteria: History of human immunodeficiency virus (HIV) Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation Known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet Creatinine clearance (CrCl) of <80 mL/min History of malignant disease Presence of pulmonary disease A body mass index (BMI) ≥40 (BMI formula: BMI = mass [kg]/[height(m)]2) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Research site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Research site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Research site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Research site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Research site
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Research site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Research site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Research site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Research site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Research site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
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United States
Facility Name
Research site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
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United States
Facility Name
Research site
City
Pleven
ZIP/Postal Code
5800
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Bulgaria
Facility Name
Research site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Research site
City
Sofia
ZIP/Postal Code
1142
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Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research site
City
Sofia
ZIP/Postal Code
1431
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Bulgaria
Facility Name
Research site
City
Sofia
ZIP/Postal Code
1606
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Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
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City
Brno
ZIP/Postal Code
62500
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Czech Republic
Facility Name
Research site
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Research site
City
Chocen
ZIP/Postal Code
56501
Country
Czech Republic
Facility Name
Research site
City
Havirov
ZIP/Postal Code
73601
Country
Czech Republic
Facility Name
Research site
City
Jihlava
ZIP/Postal Code
58633
Country
Czech Republic
Facility Name
Research site
City
Pardubice
ZIP/Postal Code
53203
Country
Czech Republic
Facility Name
Research site
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Research site
City
Praha 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Research site
City
Teplice
ZIP/Postal Code
41501
Country
Czech Republic
Facility Name
Research site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Research site
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Research site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Research site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Research Site
City
Gallarate
Country
Italy
Facility Name
Research site
City
Messina
ZIP/Postal Code
98121
Country
Italy
Facility Name
Research site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Research site
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Research site
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Research site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Research site
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Research site
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Research Site
City
Breda
ZIP/Postal Code
4818
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Netherlands
Facility Name
Research Site
City
s-Hertogenbosch
ZIP/Postal Code
5223
Country
Netherlands
Facility Name
Research Site
City
Sittard-Geleen
ZIP/Postal Code
6162
Country
Netherlands
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Research site
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Research site
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-749
Country
Poland
Facility Name
Research site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Research Site
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Facility Name
Research site
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Research site
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Research site
City
Lodz
ZIP/Postal Code
90-324
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Poland
Facility Name
Research site
City
Olsztyn
ZIP/Postal Code
10-561
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Poland
Facility Name
Research site
City
Plewiska
ZIP/Postal Code
62064
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Poland
Facility Name
Research site
City
Rzeszow
ZIP/Postal Code
35055
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Poland
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Research site
City
Warsaw
ZIP/Postal Code
00-669
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Poland
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Research site
City
Warsaw
ZIP/Postal Code
01-697
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Poland
Facility Name
Research site
City
Warsaw
ZIP/Postal Code
04-749
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Poland
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420021
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Russian Federation
Facility Name
Research site
City
Kemerovo
ZIP/Postal Code
650066
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Russian Federation
Facility Name
Research site
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Research site
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
ZIP/Postal Code
60155
Country
Russian Federation
Facility Name
Research site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Research site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Research site
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Research site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Research site
City
Romford
State/Province
Essex
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Research site
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Research site
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Research site
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Research site
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Research site
City
Cardiff
State/Province
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Research site
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Research site
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom
Facility Name
Research site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Research site
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Research site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30535670
Citation
Hobart J, Ziemssen T, Feys P, Linnebank M, Goodman AD, Farrell R, Hupperts R, Blight AR, Englishby V, McNeill M, Chang I, Lima G, Elkins J; ENHANCE study investigators. Assessment of Clinically Meaningful Improvements in Self-Reported Walking Ability in Participants with Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III ENHANCE Trial of Prolonged-Release Fampridine. CNS Drugs. 2019 Jan;33(1):61-79. doi: 10.1007/s40263-018-0586-5.
Results Reference
derived

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

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