Multiple SclerosisRETROFAMNCT02966808
Retrospective Observational Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost 93% of patients in the first 15 years of the disease, being a clear problem for their normal living. Nevertheless, therapeutic options for this symptom are few and optimal for only some patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- cognitive and behavioural questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2016to Dec 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with multiple sclerosis elegible for fampridine treatment according to drug lable.
Who may be able to join
- patients with multiple sclerosis with fampridine treatment
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Yolanda Higueras, PhD contact
María Luisa Martínez-Ginés, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Yolanda Higueras, PhD, +34654129540, yolandahigueras@googlemail.com
María Luisa Martínez-Ginés, MD, +34914269610, marisamgines@hotmail.com
About this study
Official title: Retrospective Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis
Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost 93% of patients in the first 15 years of the disease, being a clear problem for their normal living. Nevertheless, therapeutic options for this symptom are few and optimal for only some patients.
Read the detailed description
The mechanism of action of fampridine has a direct effect on mobility and it´s based on voltage-dependent potassium channels functioning, causing an improvement of conductivity of action-potential in neurons. This is why nowadays is the only approved drug to treat walking and mobility problems in MS. Results obtained after Phase III randomized clinical trials proved improvement in walking ability measured using the Timed 25 Walking Feet test (T25WF).
There are few studies regarding fampridine effects on symptoms different from mobility. The ENABLE Phase VI study found the first data related with the long-term impact of this treatment in physical and psychological function in patients according to their own perception. Results from this study indicated that, after one year of treatment, patients perceived a sustained benefit in their health, both physical and psychologically.
- Conditions
- Multiple Sclerosis
- Being tested
- cognitive and behavioural questionnaires
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive and behavioural questionnairesBehavioural
Also called PASAT, SDMT, MSQoL-54, MSFIS, T25WF, MSWS12
| Study group | Role | What they receive |
|---|---|---|
| Clinical measures | multiple sclerosis patients in treatment with fampridine Receives: Behavioral: cognitive and behavioural questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in speed of processing
Symbol Digit Modality Test (SDMT)
Measured: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
change in attention
Paced Auditory Serial Addition Test (PASAT)
Measured: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
change in walking ability
Timed 25 walking feet (T25WF)
Measured: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
change in perception of walking ability
Multiple Sclerosis Walking Scale 12 (MSWS12)
Measured: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
Secondary outcomes (2)
change in fatigue
Multiple Sclerosis Fatigue Impact Scale (MSFIS)
Measured: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
change in quality of life
Multiple Sclerosis Quality of Life 54 (MSQoL-54)
Measured: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Luisa Martinez Gines, Hospital General Universitario Gregorio Marañon
- Investigators
- Maria Luisa Martínez-Ginés, MD, Principal investigator, Neurologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966808
- Sponsor's protocol ID
- RETROFAM
- Acronym
- RETROFAM
- Status last verified
- Feb 2021
- First submitted
- 2 Nov 2016
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02966808
- Acronym / sponsor ID
- RETROFAM / RETROFAM
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Nov 2016 (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.
Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost 93% of patients in the first 15 years of the disease, being a clear problem for their normal living. Nevertheless, therapeutic options for this symptom are few and optimal for only some patients.
Detailed description
The mechanism of action of fampridine has a direct effect on mobility and it´s based on voltage-dependent potassium channels functioning, causing an improvement of conductivity of action-potential in neurons. This is why nowadays is the only approved drug to treat walking and mobility problems in MS. Results obtained after Phase III randomized clinical trials proved improvement in walking ability measured using the Timed 25 Walking Feet test (T25WF).
There are few studies regarding fampridine effects on symptoms different from mobility. The ENABLE Phase VI study found the first data related with the long-term impact of this treatment in physical and psychological function in patients according to their own perception. Results from this study indicated that, after one year of treatment, patients perceived a sustained benefit in their health, both physical and psychologically.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical measures | – | Behavioral: cognitive and behavioural questionnairesmultiple sclerosis patients in treatment with fampridine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with multiple sclerosis elegible for fampridine treatment according to drug lable.
Key inclusion criteria (1 listed)
- patients with multiple sclerosis with fampridine treatment
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| cognitive and behavioural questionnairesAlso: PASAT, SDMT, MSQoL-54, MSFIS, T25WF, MSWS12 | Behavioural | Clinical measures |
Primary outcome
Change in speed of processing
Time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
Symbol Digit Modality Test (SDMT)
change in attention
Time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
Paced Auditory Serial Addition Test (PASAT)
change in walking ability
Time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
Timed 25 walking feet (T25WF)
change in perception of walking ability
Time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
Multiple Sclerosis Walking Scale 12 (MSWS12)
2 secondary outcomes
change in fatigue
Time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
change in quality of life
Time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- 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.
Yolanda Higueras, PhD contact
María Luisa Martínez-Ginés, MD contact
Maria Luisa Martínez-Ginés, MD principal investigator
Neurologist
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 Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yolanda Higueras, PhD (yolanda.higueras@iisgm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in speed of processing (time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021.