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Clinical Trials/DRKS00004877
DRKS00004877
Completed
Not Applicable

Resistant MS Spasticity Treatment with Sativex and Driving

Almirall S.A.0 sites33 target enrollmentApril 10, 2013
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ConditionsMS SpasticityG35Multiple sclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
MS Spasticity
Sponsor
Almirall S.A.
Enrollment
33
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 10, 2013
End Date
April 10, 2013
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility 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

  • •\*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

Outcomes

Primary Outcomes

Not specified

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