Evaluation of the efficacy of Xeomin in the treatment of cervical dystonia (CD) and blepharospasmus (BS) in patients who did not respond to treatment with Botox. - ND

Conditions: cervical dystonia, blepharospasmus (BS)
MedDRA version: 9.1Level: PTClassification code 10005159
MedDRA version: 9.1Level: LLTClassification code 10064124

Registration Number: EUCTR2010-018345-64-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

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

Diagnosis of focal dystonia (torcicollis or primary blepharospasmus)
-Age > 18
-Prior treatment with botulinum toxin type A, considered not responder.
-Ability to give consent
-No pharmacological treatment changement in the 4 weeks preceding the study and during all the study period.
-No strength deficit in the muscles of interest.
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

-Neuromuscular junction diseases
-Infection or inflammation in the site of injection
-Hypersensitivity to the product or to one of its components.
-Women who can not exclude pregnancy during the study; women who are pregnant or are breastfeeding.
-Current treatment with drugs interfering with neuromuscular (e.g. amynoglicoside antibiotics, . antibiotici aminoglicosidi, penicillamine, quinine, calcium channel blockers)
- Alcohol abuse
-Drug abuse
-Severe sistemic diseases, neuropsychiatric and ophthalmologic diseases

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: nd;Main Objective: to evaluate the efficacy of NT 201 (Xeomin) in the treatment of CD and BS in patients non-responders to treatment with Botox.;Primary end point(s): nd

Secondary Outcome Measures