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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018345-64-IT

Enrollment

Registered

2010-07-05

Start date

2011-03-23

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical dystonia, blepharospasmus (BS) MedDRA version: 9.1 Level: PT Classification code 10005159 MedDRA version: 9.1 Level: LLT Classification code 10064124

Interventions

Trade Name: XEOMIN Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Botulinum toxin Concentration unit: U unit(s) Concentration type: equal Concentration number: 300- Trade

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: nd;Primary end point(s): nd	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026