A comparison of Dysport (100 U/ml) and Botox (100 U/ml) using dose conversion factor 3:1 and 1.7:1 in the treatment of cervical dystonia. - DysBot

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005819-18-SE

Enrollment

Registered

2009-02-27

Start date

2009-06-30

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Cervical dystonia, not multifocal or generalised dystonia. MedDRA version: 9.1 Level: LLT Classification code 10064124 Term: Cervical dystonia

Interventions

Trade Name: Botox Product Name: Botox Pharmaceutical Form: Powder for injection* Trade Name: Dysport Product Name: Dysport Pharmaceutical Form: Powder for injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are 18 years of age or older with diagnosed cervical dystonia that has been treated with Dysport regularly for at least one year prior to the study with stabilised treatment response. Signed informed consent must be obtained before any study-related procedures are conducted. 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: Contraindications to any of the investigational products, pregnancy or lactation, multifocal or generalised dystonia, patients with deep brain stimulation (DBS) treatment, patients with ongoing pronounced variability in daily bensodiazepine dose, = 2 mg clonazepam or corresponding doses of other bensodiazepines, patients suffering from other conditions that, in the opinion of the investigator, might interfere with the study objectives or patients that, in the opinion of the investigator, are unable to comply with study requirements.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the difference in treatment effect between Dysport (100 U/ml) and Botox (100 U/ml) for dose conversion factor 3:1 (Dysport:Botox). The aim is to find out if the dose conversion factor 3:1 (Dysport:Botox) is too large.;Secondary Objective: To evaluate the difference in treatment effect between Dysport (100 U/ml) and Botox (100 U/ml) for dose conversion factor 1.7:1 (Dysport:Botox). To evaluate the difference in disease severity between Dysport (100 U/ml) and Botox (100 U/ml) for dose conversion factor 3:1 and 1.7:1 (Dysport:Botox). ;Primary end point(s): 4 weeks after each treatment the effect is evaluated with Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score, for each patient.	—

Measure

Time frame

Main Objective: To evaluate the difference in treatment effect between Dysport (100 U/ml) and Botox (100 U/ml) for dose conversion factor 3:1 (Dysport:Botox). The aim is to find out if the dose conversion factor 3:1 (Dysport:Botox) is too large.;Secondary Objective: To evaluate the difference in treatment effect between Dysport (100 U/ml) and Botox (100 U/ml) for dose conversion factor 1.7:1 (Dysport:Botox). To evaluate the difference in disease severity between Dysport (100 U/ml) and Botox (100 U/ml) for dose conversion factor 3:1 and 1.7:1 (Dysport:Botox). ;Primary end point(s): 4 weeks after each treatment the effect is evaluated with Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score, for each patient.

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Countries

Sweden

Outcome results

None listed

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