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Register:	ClinicalTrials.gov
Last refreshed on:	8 February 2021
Main ID:	NCT02849782
Date of registration:	22/07/2016
Prospective Registration:	No
Primary sponsor:	Centre Hospitalier Universitaire de Besancon
Public title:	Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine. FAMPISEP
Scientific title:	Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor Performances
Date of first enrolment:	February 4, 2014
Target sample size:	89
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02849782
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
France

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- MS diagnostic regarding the modified McDonald criteria

- EDSS status between 4.0 and 6.5

- patients able to walk during 6 minutes

Exclusion Criteria:

- increasing MS symptoms during the previous 60 days

- history of epilepsy or epileptic seizure

- immunotherapy change in the previous 60 days

- beginning anti-spastic treatment in the previous 30 days

- beginning treatment that is able to decrease fatigue symptoms in the previous 30 days

- modification of the rehabilitation program during the study

- renal insufficiency (creatinine clearance <80ml.min-1 given by the Cockroft-Gault
formula)

- concomitant treatment by organic cation transporter 2 inhibitor

- hypersensitivity to fampridine

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Fampridine

Primary Outcome(s)

6 Minute Walk Test (6MWT) [Time Frame: Timed 21 days]

Secondary Outcome(s)

6 Minute Walk Test (6MWT) [Time Frame: day 7]

Fatigue Severity Scale (FSS) [Time Frame: 21 days]

Modified Fatigue Impact Scale (mFIS) [Time Frame: 7 days]

Multiple Sclerosis Walking Scale 12 (MSWS12) [Time Frame: day 1]

Timed 25 Walk Test (T25WT) [Time Frame: up to one year]

Verbal fluencies [Time Frame: up to one year]

6 Minute Walk Test (6MWT) [Time Frame: day 28]

Symbol Digit Modalities Test [Time Frame: 21 days]

"PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) [Time Frame: day 1]

"PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) [Time Frame: day 7]

Fatigue Severity Scale (FSS) [Time Frame: 7 days]

Symbol Digit Modalities Test [Time Frame: 7 days]

Timed 25 Walk Test (T25WT) [Time Frame: 28 days]

Timed 25 Walk Test (T25WT) [Time Frame: 7 days]

Symbol Digit Modalities Test [Time Frame: up to one year]

Timed Up and Go test (TUG) [Time Frame: 28 days]

Verbal fluencies [Time Frame: 7 days]

"PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) [Time Frame: day 21]

"PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) [Time Frame: up to one year]

Modified Fatigue Impact Scale (mFIS) [Time Frame: up to one year]

Multiple Sclerosis Walking Scale 12 (MSWS12) [Time Frame: up to one year]

Timed Up and Go test (TUG) [Time Frame: 7 days]

Verbal fluencies [Time Frame: 28 days]

Fatigue Severity Scale (FSS) [Time Frame: day 1]

Modified Fatigue Impact Scale (mFIS) [Time Frame: 21 days]

Multiple Sclerosis Walking Scale 12 (MSWS12) [Time Frame: 21 days]

Physical activity in real life condition [Time Frame: During 7 days (day 1 to day 7)]

Symbol Digit Modalities Test [Time Frame: 28 days]

Symbol Digit Modalities Test [Time Frame: Day 1]

Timed 25 Walk Test (T25WT) [Time Frame: Day 1]

Timed Up and Go test (TUG) [Time Frame: 21]

Timed Up and Go test (TUG) [Time Frame: Day 1]

Verbal fluencies [Time Frame: Day 1]

"PERception de la Sclérose En Plaques et de ses Poussées" (PERSEPP) [Time Frame: day 28]

Modified Fatigue Impact Scale (mFIS) [Time Frame: 28 days]

6 Minute Walk Test (6MWT) [Time Frame: day 1]

6 Minute Walk Test (6MWT) [Time Frame: up to one year]

Modified Fatigue Impact Scale (mFIS) [Time Frame: day 1]

Multiple Sclerosis Walking Scale 12 (MSWS12) [Time Frame: 7 days]

Fatigue Severity Scale (FSS) [Time Frame: 28 days]

Fatigue Severity Scale (FSS) [Time Frame: up to one year]

Multiple Sclerosis Walking Scale 12 (MSWS12) [Time Frame: 28 days]

Physical activity in real life condition [Time Frame: During 7 days (day 21 to day 28)]

Timed 25 Walk Test (T25WT) [Time Frame: 21 days]

Timed Up and Go test (TUG) [Time Frame: up to one year]

Verbal fluencies [Time Frame: 21 days]

Secondary ID(s)

API/2014/49

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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