Resistant MS Spasticity Treatment with Sativex and Driving
- Conditions
- MS SpasticityG35Multiple sclerosis
- Registration Number
- DRKS00004877
- Lead Sponsor
- Almirall S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 33
*= 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
*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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method