An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice (LIBERATE)

June 4, 2019 updated by: Biogen

A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)

The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4734

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C10161ABD
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Salta, Argentina
        • Research Site
    • Buenos Aires
      • Ciudad Autonoma de Buanos Aires, Buenos Aires, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
  • Canada
    • British Colombia
      • Burnaby, British Colombia, Canada, V5H 4K7
        • Research Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 0C7
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6W 2Z8
        • Research Site
      • London, Ontario, Canada, N6A 5A5
        • Research Site
      • London, Ontario, Canada, N6A 5A5
        • Reasearch Center
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
  • Czechia
      • Brno, Czechia
        • Research Site
      • Olomouc, Czechia
        • Research Site
      • Pardubice, Czechia
        • Research Site
      • Praha 10, Czechia
        • Research Site
      • Praha 2, Czechia
        • Research Site
  • France
      • Angers, France
        • Research Site
      • Bayonne, France
        • Research Site
      • Bordeaux Cedex, France
        • Research Site
      • Bron Cedex, France
        • Research Site
      • Caen, France
        • Research Site
      • Cahors cedex 6, France
        • Research Site
      • Cergy, France
        • Research Site
      • Colmar, France
        • Research Site
      • Dax cedex, France
        • Research Site
      • Dijon, France
        • Research Site
      • Dijon Cedex, France
        • Research Site
      • Gonesse, France
        • Research Site
      • La Seyne sur Mer, France
        • Research Site
      • Le Mans cedex 09, France
        • Research Site
      • Lille cedex, France
        • Research Site
      • Limoges, France
        • Research Site
      • Lisieux, France
        • Research Site
      • Lyon, France
        • Research Site
      • Mantes La Jolie cedex, France
        • Research Site
      • Marseille, France
        • Research Site
      • Montauban, France
        • Research Site
      • Montbéliard cedex, France
        • Research Site
      • Montluçon, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Montpellier cedex 5, France
        • Research Site
      • Nancy, France
        • Research Site
      • Nimes, France
        • Research Site
      • Niort Cedex, France
        • Research Site
      • Orléans, France
        • Research Site
      • Paris, France
        • Research Site
      • Paris cedex 19, France
        • Research Site
      • Poitiers cedex, France
        • Research Site
      • Pringy cedex, France
        • Research Site
      • Quimper cedex, France
        • Research Site
      • Rambouillet, France
        • Research Site
      • Roanne cedex, France
        • Research Site
      • Rouen, France
        • Research Site
      • Rueil Malmaison, France
        • Research Site
      • Saint Malo cedex, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Tourcoing cedex, France
        • Research Site
      • Vichy Cedex, France
        • Research Site
    • Lot Et Garonne
      • Agen cedex 09, Lot Et Garonne, France, 47923
        • Research Site
    • Sein Maritime
      • Rouen, Sein Maritime, France, 76031
        • Research Site
    • Seine-Maritime
      • Bois-Guillaume, Seine-Maritime, France, 76230
        • Research Site
  • Germany
      • Abensberg, Germany
        • Research Site
      • Altenholz, Germany
        • Research Site
      • Aschaffenburg, Germany
        • Research Site
      • Bad Krozingen, Germany
        • Research Site
      • Bamberg, Germany
        • Research Site
      • Bayreuth, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Bogen, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Butzbach, Germany
        • Research Site
      • Eisenach, Germany
        • Research Site
      • Erbach, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Grevenbroich, Germany
        • Research Site
      • Hagen, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Herford, Germany
        • Research Site
      • Itzehoe, Germany
        • Research Site
      • Kastellaun, Germany
        • Research Site
      • Landshut, Germany
        • Research Site
      • Lappersdorf, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Muenchen, Germany
        • Research Site
      • Neu-Ulm, Germany
        • Research Site
      • Neuburg, Germany
        • Research Site
      • Oldenburg, Germany
        • Research Site
      • Ostfildern, Germany
        • Research Site
      • Ravensburg, Germany
        • Research Site
      • Singen, Germany
        • Research Site
      • Sinsheim, Germany
        • Research Site
      • Stade, Germany
        • Research Site
      • Stuttgart, Germany
        • Research Site
      • Trier, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
      • Unterhaching, Germany
        • Research Site
    • Baden Wuerttemberg
      • Sindelfingen, Baden Wuerttemberg, Germany, 71034
        • Research Site
    • Bayern
      • Karlstadt, Bayern, Germany, 97753
        • Research Site
      • Lohr Am Main, Bayern, Germany, 97816
        • Research Site
      • Muenchen, Bayern, Germany, 81825
        • Research Site
      • Neusass, Bayern, Germany, 86356
        • Research Site
    • Niedersachsen
      • Gottingen, Niedersachsen, Germany, 37073
        • Research Site
    • Nordsachsen
      • Wermsdorf, Nordsachsen, Germany, 04779
        • Research Site
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Research Site
    • Thuringia
      • Stadtroda, Thuringia, Germany, 07646
        • Research Site
  • Ireland
      • Dublin, Ireland
        • Research Site
  • Israel
      • Haifa, Israel
        • Research Site
      • Jerusalem, Israel
        • Research Site
      • Tel Aviv, Israel
        • Research Site
  • Lebanon
      • Beirut, Lebanon
        • Research Site
  • Netherlands
      • Almelo, Netherlands
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Arnhem, Netherlands, 6800 TA
        • Research Site
      • Blaricum, Netherlands
        • Research Site
      • Breda, Netherlands
        • Research Site
      • Dordrecht, Netherlands
        • Research Site
      • Eindhoven, Netherlands
        • Research Site
      • Emmen, Netherlands
        • Research Site
      • Enschede, Netherlands
        • Research Site
      • Gouda, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Heerenveen, Netherlands, 8441 PW
        • Research Site
      • Hoorn, Netherlands
        • Research Site
      • Leeuwarden, Netherlands
        • Research Site
      • Leiden, Netherlands
        • Research Site
      • Meppel, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Nijmegen, Netherlands, 6500 GS
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Sittard Geleen, Netherlands, 6162 BG
        • Research Site
      • Sneek, Netherlands
        • Research Site
      • Tilburg, Netherlands
        • Research Site
      • Venlo, Netherlands
        • Research Site
      • Vlissingen, Netherlands
        • Research Site
      • Zutphen, Netherlands
        • Rsearch Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Molde, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
  • Portugal
      • Amadora, Portugal
        • Research Site
      • Braga, Portugal
        • Research Site
      • Faro, Portugal
        • Research Site
      • Guimaraes, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Loures, Portugal
        • Research Site
      • Matosinhos, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Viana do Castelo, Portugal
        • Research Site
  • Spain
      • Alicante, Spain
        • Research Site
      • Avila, Spain
        • Research Site
      • Caceres, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • La Coruña, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Málaga, Spain
        • Research Site
      • Segovia, Spain
        • Research Site
      • Valladolid, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07010
        • Research Site
    • Madrid
      • Getafe, Madrid, Spain
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spain
        • Research Site
    • Tenerife
      • San Cristobal de La laguna, Tenerife, Spain
        • Research Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain
        • Site Research
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Research Site
      • Dubai, United Arab Emirates
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This post marketing study will be carried out by neurologists in routine clinical settings.

Description

Key Inclusion Criteria:

  • MS patients with any disease subtype who are ≥18 years of age and must have been newly prescribed Fampyra but not yet started the treatment.
  • Patients who are willing and able to provide written informed consent.

Key Exclusion Criteria:

  • None

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Fampyra
Fampyra administered as prescribed in routine clinical practice.
Drug: Fampridine
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
Other Names:
  • Ampyra
  • dalfampridine
  • Fampyra
  • BIIB041
  • fampridine prolonged-release tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: Day 1 up to one year
Day 1 up to one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Utilization patterns of Fampyra in Routine Clinical Practice
Time Frame: Day 1 up to one year
Variables to be characterized include reason for Fampryra use, dose and duration of use, dosing deviations from local Fampyra label, and reasons for dosage changes.
Day 1 up to one year
Effectiveness of risk minimization measures
Time Frame: Day 1 up to one year
Variables to be characterized may include demographics, medical history, reasons for Fampyra use, dose deviation from local Fampyra label and overdoses.
Day 1 up to one year
Change from Baseline in Physician's Clinical Global Impression of Improvement (CGI-I) of Walking Ability Assessed Whenever the Multiple Sclerosis Participant is Seen by the Neurologist
Time Frame: Baseline, Day 1 up to one year
The Clinical Global Impression-Improvement (CGI-I) scale is a 7-point scale that requires the clinician to rate the improvement or worsening of the overall walking ability of the patient.
Baseline, Day 1 up to one year
Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)
Time Frame: Baseline, Months 3, 6, 9, 12
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, Months 3, 6, 9, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 218MS401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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