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Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease

Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011155
Enrollment
Unknown
Registered
2017-04-16
Start date
2017-04-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Parkinson’s disease

Interventions

treatment group:dihydroergotoxine mesylate 2.5 mg, twice daily, two weeks
intervention group:identical placebo 2.5 mg, twice daily, two weeks

Sponsors

Nanjing First Hospital Affiliated to Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients were diagnosed with idiopathic PD according to the UK Parkinsons Disease Society Brain Bank criteria; 2. Patients were required to have obvious to severe sialorrhea (United Parkinsons Disease Rating Scale [UPDRS] part II [item 6] salivation score rating of three or higher); 3. patients should be at least 18 years old; 4. patient or a caregiver had to be able to score the extent of sialorrhea on a daily basis.

Exclusion criteria

Exclusion criteria: 1. sialorrhea caused by factors other than PD (e.g. badly fitted dentures); 2. a known hypersensitivity to dihydroergotoxine mesylate; 3. BoNT for drooling within the past three months; 4. symptomatic bradycardia, severe postural hypotension, symptomatic coronary insufficiency, severe organic heart damage, severe hepatic and renal dysfunction, active psychosis, and pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
the Sialorrhea Clinical Scale for PD (SCS-PD);

Secondary

MeasureTime frame
(United Parkinson’s Disease Rating Scale;

Countries

China

Contacts

Public ContactYouyong Tian

Nanjing First Hospital Affiliated to Nanjing Medical University

tyy9956@163.com+86 18951670114

Outcome results

None listed

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