EFFICACY AND SAFETYOF BOTULINUM TOXIN THERAPY ON UPPER LIMB SPASTICITY IN INFLAMMATORY AND DEMIELINIZZATING DISEASE OF CENTRAL NERVOUS SYSTEM. - ND

Conditions: multiple sclerosis
MedDRA version: 9.1Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressive

Registration Number: EUCTR2007-006268-32-IT

Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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; .......

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures