NCT07585565Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Monosialotetrahexosylganglioside Sodium Injection in Parkinson's Disease Participants With Motor Fluctuations
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Monosialotetrahexosylganglioside Sodium Injection in Parkinson's Disease Participants With Motor Fluctuations
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 27 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Parkinson disease
- NCT number
- NCT07585565
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 276
- From 1 May 2026 to the primary completion date, 31 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgical treatment for Parkinson's disease or planned such surgery during the trial period.
Other illness
- 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.
- 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 .
Lab values
- Known allergy to monosialotetrahexosylganglioside sodium or any excipient of the investigational product.
Who the study is looking for
- 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.
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.