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Efficacy and safety of GM-1 in the treatment of Parkinson's disease: a prospective, multicenter, self controlled clinical study

Efficacy and safety of GM-1 in the treatment of Parkinson's disease: a prospective, multicenter, self controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042537
Enrollment
Unknown
Registered
2021-01-23
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-03

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

Conditions

Parkinson's disease

Interventions

Low dose group:GM-1 was given intravenously, 100 mg / d
High dose group:GM-1 was given intravenously, 200 mg / d

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female subjects, aged > 30 years and <= 70 years; 2. Subjects who met the "diagnostic criteria for Parkinson's disease" formulated by the International Movement Disorders Association (MDS) in 2015; 3. Patients with early Parkinson's disease, course of disease < 10 years, Hoehn Yahr 1-3 grade; 4. The subjects who received a stable dose of dopserazide tablets, dopamine receptor agonists or monoamine oxidase type B inhibitors for one month before study enrollment; 5. Subjects who signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with disturbance of consciousness, aphasia and mental illness; Patients with major depression; 2. Patients with parkinsonism and secondary parkinsonism (hepatolenticular degeneration, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.); 3. Patients with long-term use of dopamine blockers (e.g. powerful nerve stabilizer, sibelium, reserpine, metoclopramide, etc.); 4. Patients who used GM1 within three months; 5. Patients with transient ischemic attack within six months; 6. Subjects with two or more stroke history or stroke sequelae within 6 months before enrollment; 7. Patients with hereditary abnormal glucose and lipid metabolism (ganglioside accumulation disease, such as familial amaurosis and retinal degeneration); 8. Patients with Guillain Barre syndrome, chronic idiopathic peripheral neuropathy and polyneuropathy; 9. Patients with positive ganglioside antibody; 10. Patients allergic to monosialotetrahexosylganglioside sodium injection; 11. Long term exposure to any known neurotoxins that may cause Parkinson's disease; Long term or short-term use of any drug that may cause dyskinesia; 12. Subjects of stereotactic brain surgery for PD; 13. Patients with severe cardiopulmonary instability, liver and kidney dysfunction (more than 3 times of normal value); 14. Patients who can't cooperate with neuropsychological test; 15. Patients who do not follow the prescribed treatment plan have poor compliance; 16. Patients considered unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
scores of motor symptoms and non-motor symptoms and the changes of plasma oxidative stress markers;

Countries

China

Contacts

Public ContactLiu Yiming

Qilu Hospital of Shandong University

amyliu831@163.com+86 18560085383

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026