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RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND

RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017412-32-IT
Enrollment
Unknown
Registered
2010-04-27
Start date
2011-12-13
Completion date
Unknown
Last updated
2013-07-15

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

Conditions

Parkinson disease MedDRA version: 9.1 Level: LLT Classification code 10013363

Interventions

Trade Name: BOTOX Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Botulinum toxin Concentration unit: U unit(s) Concentration type: equal Concentration number: 100- Trade

Sponsors

AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Parkinson disease patients (>18 yrs) Drooling >2 (UPDRS-II) Written informed consent 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: previous or contraindications to botulinum toxin injections presence of comorbilities (alcool addiction, HIV, psychiatric or endocrine disease), pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate botulinum toxin type A and B in the treatment of drooling in parkinson disease;Secondary Objective: To evaluate the safety of the treatament;Primary end point(s): Drooling reduction 1 month after botulinum toxin injections evautated according to UPDRS-II—

Countries

Italy

Outcome results

None listed

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