Multiple SclerosisFAMILYNCT03164018
Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis
An observational study of Multiple Sclerosis, run by Genesis Pharma CNS & Specialty at 1 site in Greece.
Trial summary
Fampyra, a voltage-dependent potassium channel blocker, is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). The medicinal product has been authorized under a so-called "conditional approval" scheme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fampridine
- How many people
- 111 participants
- Where
- 1 siteGreece
- Study dates
- 7 Mar 2017to 15 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population of the current clinical study is male and female patients with MS, aged ≥18 years, receiving Fampyra for walking disability according to standard clinical practice.
Who may be able to join
- Adult patient (≥18 years old) with MS.
- Patient receiving Fampyra® for walking disability (EDSS 4-7).
- Patient receiving stable doses of any Disease Modifying Treatment (DMT) for at least 3 months prior to study entry.
- Patients will receive Fampyra® in line with the approved Summary of Product Characteristics (SmPC).
- Patients for whom the decision to prescribe therapy with Fampyra according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study.
- Patients must have signed an informed consent document.
- Patients must be able to read, understand and complete the study specific questionnaires.
Who cannot join
- Pregnant or lactating woman.
- Patient with prior history or current presentation of seizure.
- Patient with mild, moderate or severe renal impairment (creatinine clearance < 80 ml/min).
- Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine).
- Concomitant treatment with medicinal products that are inhibitors of Organic Transporter 2 (OCT2), e.g., cimetidine.
- Patients who have received more than 1 dose of fampridine at the time of enrollment into the study.
- Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC.
- Patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with fampridine
Trial locations and contacts
1 site in 1 country.
About this study
Fampyra, a voltage-dependent potassium channel blocker, is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). The medicinal product has been authorized under a so-called "conditional approval" scheme. This means that further evidence on this medicinal product is awaited and this study aims to assess the effect of Fampyra, administered according to standard clinical practice, on cognition, fatigue and quality of life in patients with MS.
This clinical study is a multicenter, prospective, non-interventional, cohort study of MS patients receiving Fampyra in outpatient setting. Patients will be treated according to the local prescribing information of the study medication and routine medical practice in terms of visit frequency and types of assessments performed. The assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of Fampyra is clearly separated from the physician's decision to include the patient in the current study.
Since this is purely non-interventional study, primary data -which will be obtained prospectively during the study visits through patients' interview and patient reported outcomes or as performed per standard clinical practice- will mainly be employed.
Read the detailed description
The study will take place in Greece. Investigator's decision to prescribe Fampyra (according to the indication for treatment as defined in the summary of product characteristics, SmPC and the current clinical practice), should precede entry into the study.
- 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
The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments and management of the disease will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behavior.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognition measured with PASAT scale
Correlated with the multidimensional Health Related Quality of Life in MS patients
Measured: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
Changes in depression measured with BDI-II scale
Correlated with the multidimensional Health Related Quality of Life in MS patients
Measured: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
Changes in fatigue measured with MFIS scale
Correlated with the multidimensional Health Related Quality of Life in MS patients
Measured: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
Changes in Quality of Life measured with MusiQoL scale
Correlated with the multidimensional Health Related Quality of Life in MS patients
Measured: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0)
Changes in Quality of Life measured with MSIS-29 scale
Correlated with the multidimensional Health Related Quality of Life in MS patients
Measured: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start7 Mar 2017
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
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.
- 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genesis Pharma CNS & Specialty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164018
- Sponsor's protocol ID
- NIS-GEN-FMP-001
- Acronym
- FAMILY
- Status last verified
- Feb 2019
- First submitted
- 29 Mar 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mitsikostas DD, Doskas T, Gkatzonis S, Fakas N, Maltezou M, Papadopoulos D, Gourgioti R, Mitsias P. A Prospective, Observational, Cohort Study to Assess the Efficacy and Safety of Prolonged-Release Fampridine in Cognition, Fatigue, Depression, and Quality of Life in Multiple Sclerosis Patients: The FAMILY Study. Adv Ther. 2021 Mar;38(3):1536-1551. doi: 10.1007/s12325-020-01606-5. Epub 2021 Feb 2.
PubMed 33528792
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis
- ClinicalTrials.gov ID
- NCT03164018
- Acronym / sponsor ID
- FAMILY / NIS-GEN-FMP-001
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Genesis Pharma CNS & SpecialtyIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 23 May 2017 (actual)
- 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.
Fampyra, a voltage-dependent potassium channel blocker, is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). The medicinal product has been authorized under a so-called "conditional approval" scheme. This means that further evidence on this medicinal product is awaited and this study aims to assess the effect of Fampyra, administered according to standard clinical practice, on cognition, fatigue and quality of life in patients with MS.
This clinical study is a multicenter, prospective, non-interventional, cohort study of MS patients receiving Fampyra in outpatient setting. Patients will be treated according to the local prescribing information of the study medication and routine medical practice in terms of visit frequency and types of assessments performed. The assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of Fampyra is clearly separated from the physician's decision to include the patient in the current study.
Since this is purely non-interventional study, primary data -which will be obtained prospectively during the study visits through patients' interview and patient reported outcomes or as performed per standard clinical practice- will mainly be employed.
Detailed description
The study will take place in Greece. Investigator's decision to prescribe Fampyra (according to the indication for treatment as defined in the summary of product characteristics, SmPC and the current clinical practice), should precede entry into the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of the current clinical study is male and female patients with MS, aged ≥18 years, receiving Fampyra for walking disability according to standard clinical practice.
Key inclusion criteria (7 listed)
- Adult patient (≥18 years old) with MS.
- Patient receiving Fampyra® for walking disability (EDSS 4-7).
- Patient receiving stable doses of any Disease Modifying Treatment (DMT) for at least 3 months prior to study entry.
- Patients will receive Fampyra® in line with the approved Summary of Product Characteristics (SmPC).
- Patients for whom the decision to prescribe therapy with Fampyra according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study.
Key exclusion criteria (8 listed)
- Pregnant or lactating woman.
- Patient with prior history or current presentation of seizure.
- Patient with mild, moderate or severe renal impairment (creatinine clearance < 80 ml/min).
- Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine).
- Concomitant treatment with medicinal products that are inhibitors of Organic Transporter 2 (OCT2), e.g., cimetidine.
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 |
|---|---|---|
| FampridineThe non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments and management of the disease will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behavior. | Drug | – |
Primary outcome
Changes in cognition measured with PASAT scale
Time frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
Correlated with the multidimensional Health Related Quality of Life in MS patients
Changes in depression measured with BDI-II scale
Time frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
Correlated with the multidimensional Health Related Quality of Life in MS patients
Changes in fatigue measured with MFIS scale
Time frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
Correlated with the multidimensional Health Related Quality of Life in MS patients
Changes in Quality of Life measured with MusiQoL scale
Time frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0)
Correlated with the multidimensional Health Related Quality of Life in MS patients
Changes in Quality of Life measured with MSIS-29 scale
Time frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0)
Correlated with the multidimensional Health Related Quality of Life in MS patients
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 15 Feb 2019.
- Derived from this study: PubMed 33528792Mitsikostas DD, Doskas T, Gkatzonis S, Fakas N, Maltezou M, Papadopoulos D, Gourgioti R, Mitsias P. A Prospective, Observational, Cohort Study to Assess the Efficacy and Safety of Prolonged-Release Fampridine in Cognition, Fatigue, Depression, and Quality of Life in Multiple Sclerosis Patients: The FAMILY Study. Adv Ther. 2021 Mar;38(3):1536-1551. doi: 10.1007/s12325-020-01606-5. Epub 2021 Feb 2.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Genesis Pharma CNS & Specialty at 1 site in Greece.
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 7 inclusion and 8 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Changes in cognition measured with PASAT scale (time frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).). The study lists 5 primary outcomes in all. 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 NCT03164018, 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 15 Feb 2019.