FindTrial
Sign In

Responsiveness to botulinum toxinum type A in complex regional pain syndrome related fixed dystonia

Responsiveness to botulinum toxinum type A in complex regional pain syndrome related fixed dystonia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019997-33-NL
Enrollment
Unknown
Registered
2010-04-14
Start date
2010-06-02
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

CRPS with dystonia MedDRA version: 12.1 Level: LLT Classification code 10013983 Term: Dystonia MedDRA version: 12.1 Level: LLT Classification code 10038249 Term: Reflex sympathetic dystrophy

Interventions

Trade Name: Botox Product Name: BoNT/A Pharmaceutical Form: Powder and solvent for solution for injection

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: CRPS with fixed dystonia of one lower extremity, age between 18 and 50, botulinum toxin naive 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: neuromuscular junction diseases, pregnancy/nursing women

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the responsiveness to BoNT/A in the affected vs non-affected vs control lower extremity;Secondary Objective: to follow-up the responsiveness in CRPS related fixed dystonia patients;Primary end point(s): difference between CMAP amplitudes pre and post injection of BoNT/A of affected vs unaffected vs control limbs—

Countries

Netherlands

Outcome results

None listed

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