A Study to Evaluate the Efficacy and Safety of Monosialotetrahexosylganglioside Sodium Injection in Parkinson's Disease Participants With Motor Fluctuations

NCT07585565 | Not Yet Recruiting Phase 2

• 1 other identifier: GM1-PD-201
• Study Type: interventional
• Target: 276
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2 study. A total of 276 eligible Parkinson's disease participants with motor fluctuations will be enrolled and assigned to one of three cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive either GM1 or matching placebo, resulting in six groups: Cohort 1 GM1 (n=69), Cohort 1 Placebo (n=23); Cohort 2 GM1 (n=69), Cohort 2 Placebo (n=23); Cohort 3 GM1 (n=69), Cohort 3 Placebo (n=23). All participants will continue their pre-enrollment anti-Parkinson's medication regimen as background therapy, which should remain as stable as possible during the study. The study consists of a 28-day screening period and an 85-day double-blind treatment period.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Total "ON" Time without Troublesome Dyskinesia as assessed by 24-hour patient diary cards.

  Baseline, Day 85

Study Arms (6)

Cohort 1 GM1

EXPERIMENTAL

Drug: GM1

Cohort 1 Placebo

PLACEBO COMPARATOR

Drug: Placebo

Cohort 2 GM1

EXPERIMENTAL

Drug: GM1

Cohort 2 Placebo

PLACEBO COMPARATOR

Drug: Placebo

Cohort 3 GM1

EXPERIMENTAL

Drug: GM1

Cohort 3 Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GM1 DRUG

1000 mg on Day 1, followed by 400 mg once daily from Day 2 to the end of Week 2, then a 2-week drug holiday.

Cohort 1 GM1

Placebo DRUG

1000 mg on Day 1, followed by 400 mg once daily from Day 2 to the end of Week 2, then a 2-week drug holiday.

Cohort 1 Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 30 years at screening.
• Clinical diagnosis of clinically established or clinically probable Parkinson's disease.
• Currently receiving levodopa therapy (stable regimen for ≥4 weeks prior to randomization, with a levodopa equivalent daily dose ≥400 mg) and experiencing motor fluctuations (including wearing-off, on-off phenomena, etc.).
• Hoehn-Yahr stage ≥2 in the "OFF" state.

You may not qualify if:

• History or presence of other Parkinsonian syndromes or Parkinson-plus syndromes, or hereditary neurodegenerative disorders.
• Diagnosis of Parkinson's disease dementia or severe cognitive impairment as judged by the investigator at screening.
• Prior surgical treatment for Parkinson's disease or planned such surgery during the trial period.
• History or presence of other neurological diseases.
• History or presence of autoimmune diseases.
• History or presence of any demyelinating diseases, including but not limited to acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome).
• History or presence of hereditary glycolipid metabolism disorders .
• Known allergy to monosialotetrahexosylganglioside sodium or any excipient of the investigational product.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Tao Feng

CONTACT

+86 13911125339; happyft@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-04