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

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219932
• Other study ID #: 218MS305
• Secondary ID: 2013-003600-40
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2014
• Last updated: April 14, 2016
• Start date: September 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Serbia: Medicines and Medical Devices Agency of SerbiaBulgaria: Ministry of HealthItaly: The Italian Medicines AgencyRussia: Ministry of Health of the Russian FederationCzech Republic: State Institute for Drug ControlUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsFinland: Finnish Medicines AgencyLithuania: State Medicine Control Agency - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on patient-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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• fampridine
Prolonged-release fampridine administered as specified in the treatment arm
• Placebo
Matched placebo

Locations

Country	Name	City	State
Bulgaria	Research site	Pleven
Bulgaria	Research site	Plovdiv
Bulgaria	Research site	Sofia
Bulgaria	Research site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research site	Sofia
Bulgaria	Research site	Sofia
Bulgaria	Research Site	Sofia
Czech Republic	Research site	Brno
Czech Republic	Research site	Brno
Czech Republic	Research site	Chocen
Czech Republic	Research site	Havirov
Czech Republic	Research site	Jihlava
Czech Republic	Research site	Pardubice
Czech Republic	Research site	Praha 2
Czech Republic	Research site	Praha 5
Czech Republic	Research site	Teplice
Finland	Research site	Helsinki
Finland	Research site	Oulu
Finland	Research site	Tampere
Finland	Research site	Turku
Italy	Research site	Messina
Italy	Research site	Milano
Italy	Research site	Milano
Italy	Research site	Napoli
Italy	Research site	Rome
Lithuania	Research site	Kaunas
Lithuania	Research site	Klaipeda
Lithuania	Research site	Vilnius
Netherlands	Research Site	Breda
Netherlands	Research Site	s-Hertogenbosch
Netherlands	Research Site	Sittard-Geleen
Poland	Research Site	Bialystok
Poland	Research site	Gdansk
Poland	Research site	Grudziadz
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research site	Katowice
Poland	Research Site	Kielce
Poland	Research site	Krakow
Poland	Research site	Krakow
Poland	Research site	Lodz
Poland	Research site	Olsztyn
Poland	Research site	Plewiska
Poland	Research site	Rzeszow
Poland	Research site	Warsaw
Poland	Research site	Warsaw
Poland	Research site	Warsaw
Poland	Research site	Warsaw
Russian Federation	Research Site	Kazan
Russian Federation	Research site	Kemerovo
Russian Federation	Research site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research site	Moscow
Russian Federation	Research Site	Nizhny Novgorod
Serbia	Research site	Belgrade
Serbia	Research site	Kragujevac
Serbia	Research site	Nis
United Kingdom	Research site	Birmingham	West Midlands
United Kingdom	Research site	Cardiff	Swansea
United Kingdom	Research site	Chertsey	Surrey
United Kingdom	Research site	Exeter	Devon
United Kingdom	Research site	Glasgow	Scotland
United Kingdom	Research site	London
United Kingdom	Research site	London
United Kingdom	Research site	London
United Kingdom	Research site	Norwich	Norfolk
United Kingdom	Research site	Nottingham
United Kingdom	Research site	Plymouth	Devon
United Kingdom	Research site	Romford	Essex
United Kingdom	Research site	Salford	Greater Manchester
United States	Research site	Bradenton	Florida
United States	Research site	Charlotte	South Carolina
United States	Research site	Charlotte	North Carolina
United States	Research site	Chesterfield	Missouri
United States	Research site	Columbus	Ohio
United States	Research site	Cullman	Alabama
United States	Research site	Detroit	Michigan
United States	Research site	Lexington	Kentucky
United States	Research site	New Bedford	Massachusetts
United States	Research Site	Orlando	Florida
United States	Research site	Pheonix	Arizona
United States	Research site	Roanoke	Virginia
United States	Research site	Rochester	New York
United States	Research site	San Diego	California
United States	Research site	Tampa	Florida
United States	Research site	Tampa	Florida
United States	Research site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Finland,  Italy,  Lithuania,  Netherlands,  Poland,  Russian Federation,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who achieve a mean improvement on the Multiple Sclerosis Walking Scale (MSWS-12) of =8-points	MSWS-12 is a patient 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.	Baseline to 24 weeks (end of study )	No
Secondary	Proportion of participants who achieve a mean improvement in Time Up and Go (TUG) speed of =15%	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	Baseline to week 24 (end of study)	No
Secondary	Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) physical score	The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient'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 to 100, where high scores indicate worse health.	Baseline to week 24 (end of study)	No
Secondary	Change in Berg Balance Scale (BBS)	The Berg Balance Scale 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. Patients are asked to complete fourteen tasks that are rated from 0 (cannot perform) to 4 (normal performance) for a total of 56 points	Baseline to week 24 (end of study)	No
Secondary	Change in ABILHAND score	The ABILHAND Questionnaire measures the 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 to 100, where high scores indicate greater impact on manual ability	Baseline to week 24 (end of study)	No