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

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-17011155
• Date of registration: 2017-04-16
• Prospective Registration: Yes
• Primary sponsor: Nanjing First Hospital Affiliated to Nanjing Medical University
• Public title: Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease
• Scientific title: Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease
• Date of first enrolment: 2017-04-20
• Target sample size: treatment group:10;intervention group:10;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=18979
• Study type: Interventional study
• Study design: Randomized cross-over control
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Yongqing Cheng
• Affiliation: Nanjing First Hospital Affiliated to Nanjing Medical University

• Name: Youyong Tian
• Affiliation: Nanjing First Hospital Affiliated to Nanjing Medical University

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson’s disease

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

(United Parkinson’s Disease Rating Scale;

Source(s) of Monetary Support

ientific research funds