Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-16009395
• Date of registration: 2016-10-14
• Prospective Registration: Yes
• Primary sponsor: The Second Affiliated Hospital of Soochow University
• Public title: Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage
• Scientific title: Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage
• Date of first enrolment: 2016-11-01
• Target sample size: Butylphthalide group and Control group:36;Control:36;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=16021
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Mao Chengjie
• Affiliation: The Second Affiliated Hospital of Soochow University

• Name: Liu Chunfeng
• Affiliation: The Second Affiliated Hospital of Soochow University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Meet the clinical diagnostic criteria for primary Parkinsons disease and require at least 2 of the cardinal motor manifestations (bradykinesia, tremor or rigidity). Clearly not attributable to other secondary parkinsonism;
2. Modified H-Y stage < 3;
3. Aged 35 years old and elder;
4. Stability of symptoms and signs over 1month or more;
5. MDS-UPDRS Part III score = 10 at baseline;
6. Dose of levodopa daily=300mg;
7. An informed consent has been signed by the patient himself/herself before the study.
Exclusion criteria: 1. Hepatic function abnormality (ALT/AST >1.5 times ULL), renal function abnormality (Cre>2.0mg/dl or 177 umol/L), cardiac dysfunction or with other severe systemic disease;
2. With occurrence of any malignancy or under oncotherapy;
3. Being allergic to celery or Butylphthalide;
4. Patient who is within the gestation period or have any possibility or intention to get pregnant;
5. Have been involved in other intervention study in the last 3 months or is now under other intervention study;
6. Patients, considered by the investigators, who is not suitable for this study.

Age minimum: 35
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson’s disease

Intervention(s)

Butylphthalide group and Control group:Butylphthalide 200mg/time(2 capsules) , three time/day, for 24 weeks;Control:No treatment;

Primary Outcome(s)

UPDRS (UPDRS part I + II + III);portable device evaluation;

Source(s) of Monetary Support

Medicine provide by company