Multiple SclerosisLIBERATENCT01480063
An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice
An observational study of Multiple Sclerosis, run by Biogen at 164 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fampridine
- Type of treatment
- Pill or oral medicine
- How many people
- 4,734 participants
- Where
- 164 sitesin 13 countries
- Study dates
- 16 Apr 2012to 8 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This post marketing study will be carried out by neurologists in routine clinical settings.
Who may be able to join
- 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.
Who cannot join
- None
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
164 sites in 13 countries.
164 sites in 13 countries
Germany48 sites
Research Site
Abensberg
Research Site
Altenholz
Research Site
Aschaffenburg
Research Site
Bad Krozingen
Research Site
Bamberg
Research Site
Bayreuth
Research Site
Berlin
Research Site
Bochum
Research Site
Bogen
Research Site
Bonn
Research Site
Butzbach
Research Site
Eisenach
Research Site
Erbach im Odenwald
Research Site
Essen
Research Site
Frankfurt
Research Site
Freiburg im Breisgau
Research Site
Göttingen, Lower Saxony, 37073
Research Site
Grevenbroich
Research Site
Hagen
Research Site
Hamburg
Research Site
Herford
Research Site
Homburg, Saarland, 66421
Research Site
Itzehoe
Research Site
Karlstadt am Main, Bavaria, 97753
Research Site
Kastellaun
Research Site
Landshut
Research Site
Lappersdorf
Research Site
Leipzig
Research Site
Lohr a. Main, Bavaria, 97816
Research Site
Mannheim
Research Site
München
Research Site
Munich, Bavaria, 81825
Research Site
Neu-Ulm
Research Site
Neuburg am Inn
Research Site
Neusäß, Bavaria, 86356
Research Site
Oldenburg
Research Site
Ostfildern
Research Site
Ravensburg
Research Site
Sindelfingen, Baden-Wurttemberg, 71034
Research Site
Singen
Research Site
Sinsheim
Research Site
Stade
Research Site
Stadtroda, Thuringia, 07646
Research Site
Stuttgart
Research Site
Trier
Research Site
Ulm
Research Site
Unterhaching
Research Site
Wermsdorf, Nordsachsen, 04779
France42 sites
Research Site
Agen, Lot Et Garonne, 47923
Research Site
Angers
Research Site
Bayonne
Research Site
Bois-Guillaume, Seine-Maritime, 76230
Research Site
Bordeaux
Research Site
Bron
Research Site
Caen
Research Site
Cahors
Research Site
Cergy
Research Site
Colmar
Research Site
Dax
Research Site
Dijon
Research Site
Gonesse
Research Site
La Seyne-sur-Mer
Research Site
Le Mans
Research Site
Lille
Research Site
Limoges
Research Site
Lisieux
Research Site
Lyon
Research Site
Mantes-la-Jolie
Research Site
Marseille
Research Site
Montauban
Research Site
Montbéliard
Research Site
Montluçon
Research Site
Montpellier
Research Site
Nancy
Research Site
Nîmes
Research Site
Niort
Research Site
Orléans
Research Site
Paris
Research Site
Poitiers
Research Site
Pringy
Research Site
Quimper
Research Site
Rambouillet
Research Site
Roanne
Research Site
Rouen, Sein Maritime, 76031
Research Site
Rouen
Research Site
Rueil-Malmaison
Research Site
St-Malo
Research Site
Toulouse
Research Site
Tourcoing
Research Site
Vichy
Netherlands25 sites
Research Site
Almelo
Research Site
Amsterdam
Research Site
Arnhem, 6800 TA
Research Site
Blaricum
Research Site
Breda
Research Site
Dordrecht
Research Site
Eindhoven
Research Site
Emmen
Research Site
Enschede
Research Site
Flushing
Research Site
Gouda
Research Site
Groningen
Research Site
Heerenveen, 8441 PW
Research Site
Hoorn
Research Site
Leeuwarden
Research Site
Leiden
Research Site
Meppel
Research Site
Nieuwegein
Research Site
Nijmegen, 6500 GS
Research Site
Rotterdam
Research Site
Sittard Geleen, 6162 BG
Research Site
Sneek
Research Site
Tilburg
Research Site
Venlo
Rsearch Site
Zutphen
Spain15 sites
Research Site
A Coruña
Research Site
Alicante
Research Site
Ávila
Site Research
Bilbao, Vizcaya
Research Site
Cáceres
Research Site
Córdoba
Research Site
Getafe, Madrid
Research Site
Madrid
Research Site
Málaga
Research Site
Palma de Mallorca, Balearic Islands, 07010
Research Site
Pamplona, Navarre
Research site
San Cristóbal de La Laguna, Tenerife
Research Site
Segovia
Research Site
Valladolid
Research Site
Zaragoza
Portugal9 sites
Research Site
Amadora
Research Site
Braga
Research Site
Faro
Research Site
Guimarães
Research Site
Lisbon
Research Site
Loures
Research Site
Matosinhos Municipality
Research Site
Porto
Research Site
Viana do Castelo
Canada6 sites
Research Site
Brampton, Ontario, L6W 2Z8
Research Site
Burnaby, British Colombia, V5H 4K7
Research Site
Fredericton, New Brunswick, E3B 0C7
Reasearch Center
London, Ontario, N6A 5A5
Research Site
London, Ontario, N6A 5A5
Research Site
Ottawa, Ontario, K1H 8L6
Argentina5 sites
Research Site
Buenos Aires, C10161ABD
Research Site
Ciudad Autonoma de Buanos Aires, Buenos Aires
Research Site
Córdoba
Research Site
Rosario, Santa Fe Province
Research Site
Salta
Czechia4 sites
Research Site
Brno
Research Site
Olomouc
Research Site
Pardubice
Research Site
Prague
United Arab Emirates2 sites
Research Site
Abu Dhabi
Research Site
Dubai
About this study
Official title: 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).
- Conditions
- Multiple Sclerosis
- Being tested
- Fampridine
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FampridineDrug
Also called Ampyra, dalfampridine, Fampyra, BIIB041
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
| Study group | Role | What they receive |
|---|---|---|
| Fampyra | Fampyra administered as prescribed in routine clinical practice. Receives: Drug: Fampridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: Day 1 up to one year
Secondary outcomes (4)
Utilization patterns of Fampyra in Routine Clinical Practice
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.
Measured: Day 1 up to one year
Effectiveness of risk minimization measures
Variables to be characterized may include demographics, medical history, reasons for Fampyra use, dose deviation from local Fampyra label and overdoses.
Measured: 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
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.
Measured: 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)
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.
Measured: Baseline, Months 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study start16 Apr 2012
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,734 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480063
- Sponsor's protocol ID
- 218MS401
- Acronym
- LIBERATE
- Status last verified
- Jun 2019
- First submitted
- 23 Nov 2011
- Last updated
- 5 Jun 2019
- Results posted
- No
Publications
Castelnovo G, Gerlach O, Freedman MS, Bergmann A, Sinay V, Castillo-Trivino T, Kong G, Koster T, Williams H, Gafson AR, Killestein J. Safety, Patient-Reported Well-Being, and Physician-Reported Assessment of Walking Ability in Patients with Multiple Sclerosis for Prolonged-Release Fampridine Treatment in Routine Clinical Practice: Results of the LIBERATE Study. CNS Drugs. 2021 Sep;35(9):1009-1022. doi: 10.1007/s40263-021-00840-x. Epub 2021 Jul 28.
PubMed 34322853
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01480063
- Acronym / sponsor ID
- LIBERATE / 218MS401
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,734 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2012 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 28 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fampyra | – | Drug: FampridineFampyra administered as prescribed in routine clinical practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This post marketing study will be carried out by neurologists in routine clinical settings.
Key inclusion criteria (2 listed)
- 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 (2 listed)
- None
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FampridineAlso: Ampyra, dalfampridine, Fampyra, BIIB041Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study. | Drug | Fampyra |
Primary outcome
Number of Participants with Adverse Events
Time frame: Day 1 up to one year
4 secondary outcomes
Utilization patterns of Fampyra in Routine Clinical Practice
Time frame: Day 1 up to one year
Effectiveness of risk minimization measures
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 34322853Castelnovo G, Gerlach O, Freedman MS, Bergmann A, Sinay V, Castillo-Trivino T, Kong G, Koster T, Williams H, Gafson AR, Killestein J. Safety, Patient-Reported Well-Being, and Physician-Reported Assessment of Walking Ability in Patients with Multiple Sclerosis for Prolonged-Release Fampridine Treatment in Routine Clinical Practice: Results of the LIBERATE Study. CNS Drugs. 2021 Sep;35(9):1009-1022. doi: 10.1007/s40263-021-00840-x. Epub 2021 Jul 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
164 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 164 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 164 sites in Germany, France, Netherlands, Spain, Portugal and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Day 1 up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.