The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
EFFICACY
25'TWT, EDSS, 9-HPT
Secondary outcome
Safety and tolerability of FTY720; MRI parameters; patient reported outcomes;
pharmacokinetics; pk/pd relationship
Background summary
At present there is no registered drug available to treat patients with PPMS.
FTY720 has shown good results in patients with relapsing-remitting MS.
This study will show whether these results can also be achieved in patients
with PPMS.
Study objective
The purpose of this study in patients with primary progressive multiple
sclerosis (PPMS) is to evaluate
whether FTY720 is effective in delaying MS disability progression in the
absence of relapses
compared to placebo. Furthermore, safety and tolerability data will be obtained
in these patients.
Study design
A double-blind; randomized, multicenter; placebo-controlled; parallel-group
study.
Intervention
One group will receive, once daily, a capsule of FTY 0.5 mg, the other group
will receive, once daily, a placebo capsule.
Study burden and risks
Burden:
In a time span of about 4.5 years, patients have to visit the hospital
approximately 23 times.
During these visits a variety of measurements/tests is being performed. Some of
them to study the efficacy of FTY720 (e.g. 25'TWT, EDSS score, and 9-HPT),
others to study the safety of FTY720 in patients with PPMS (e.g. ECG,
bloodtests, Chest X-ray, lung function tests, ophthalmology and dermatology
tests, bloodpressure).
Risks:
- In previous studies (in a different patient population) bradicardia was
observed within 6 hours of first intake. This is why
patients have to stay in hospital for 6 hours after the first intake of study
medication in the present study.
- Possible adverse events related to the collection of blood samples (bruising
etc)
- Other potential risks as listed in the patient information sheets.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
* male/female, 25 through 65 years of age inclusive
* diagnosis of primary progressive multiple sclerosis (one year of disease progression plus
at least two of the following: a) positive brain MRI, b) positive spinal cord MRI, c) positive CSF).
* time since first reported symptoms between 2 and 10 years
* documented evidence of clinical disability progression in the 2 years prior to Screening
* EDSS score of 3.5-6.0 inclusive
* pyramidal functional system score of 2 or more
* 25*TWT less than 30 seconds
Exclusion criteria
* history of MS attack/relapse
* progressive disabling neurological disorder, other than PPMS
* presence of cervical spinal cord compression (on Screening MRI)
* relevant history of vitamin B12 deficit
* history of chronic active disease of the immune system other than MS
* diagnosis of macular edema
* unable to undergo MRI scans
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-002627-32-NL |
| ClinicalTrials.gov | NCT00731692 |
| CCMO | NL18345.029.08 |