MS Spasticity G35
Conditions
Interventions
Group 1: Changes in driving abilites under therapy with Sativex were surveyed in patients with MS-spasticity. Driving ability tests were conducted on a personal computer at baseline visit and repeated
Sponsors
Almirall S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: *= 18 years old *MS patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication. *Medical decision made to start Sativex® at the time of enrolment in the study *Driving at present (at least once a week) *Indication for Sativex® in accordance with the SPC (add-on to existing antispasticity medication and all SPC requirements *Consent form signed by the patient
Exclusion criteria
Exclusion criteria: *Spasticity due to causes other than multiple sclerosis *Patients with severe cardio-vascular diseases *Pregnant woman or woman in the breast-feeding period *Reformed alcoholics *Patients with relevant cognitive impairment or shortcomings in their knowledge of national language to suggest that that the logics and the rules of the driving ability tests are not fully understood and/or the patient questionnaires cannot be completed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in driving abilites under therapy with Sativex were surveyed in patients with MS-spasticity. Driving ability tests were conducted on a personal computer at baseline visit and repeated four to six weeks after beginning therapy. | — |
Countries
Germany
Contacts
Public ContactSandra Grubmüller
ANFOMED GmbH CRO
Outcome results
None listed