Relapse-remitting Multiple Sclerosis Clinical Trial
— FingoHRVOfficial title:
Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
Verified date | May 2014 |
Source | Kuopio University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Observational |
The purpose of this study is to study the effect of fingolimod on cardiac autonomic
regulation in patients with relapse-remitting multiple sclerosis.
This will be done by measuring heart rate variability from the 24-hour Holter recording and
myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.
The fingolimod treatment is prescribed according to the accepted drug label.
Status | Completed |
Enrollment | 27 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 18 - 65 years - Understands the proposed research and actions to be taken - The written informed consent has given - clinical indication to fingolimod-treatment Exclusion Criteria: - Patient refuses - Patient takes or has taken part in other clinical drug trial during the last month - No clinical indication to the use of fingolimod - Contraindication to the use of fingolimod |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Finland | Neuro Center, Kuopio University Hospital | Kuopio | |
Finland | Department of Neurology, Mikkeli Central Hospital | Mikkeli |
Lead Sponsor | Collaborator |
---|---|
Kuopio University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in heart rate variability | prior medication vs initiation vs 3 month | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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