multiple sclerosis MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
Conditions
Interventions
Trade Name: xeomin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: xeomin
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients aged more then 18 affected by primary or secondary progressive SM or by other chronic inflammatory diseases of the CNS diagnosed 6 months before the beginning of the study;arm spasticity with 1 or more point for Modified Ashworth Scale ; ........... Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: permanent contractures or severe atrophy in spastic arm; previous treatment with BT-A or with alccol/phenol injection or surgery;modification in madical therapy or rehabilitation therapy in the prevoious 3 months; treatment with intratecal baclofen or with drugs modulationg neuromuscolar trasmission; .......
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to verify efficay and safety of one treatment with BT-A in patients affected by primary or secondary and progressive SM or by other CID influencing arm spasticity.;Secondary Objective: to verify efficay and safety of one treatment with BT-A in patients affected by primary or secondary and progressive SM or by other CID influencing arm spasticity.;Primary end point(s): to verify efficay and safety of one treatment with BT-A in patients affected by primary or secondary and progressive SM or by other CID influencing arm spasticity. | — |
Countries
Italy
Outcome results
None listed