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

9. maj 2026 opdateret af: Qilu Pharmaceutical Co., Ltd.

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

276

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 30 years at screening.
  2. Clinical diagnosis of clinically established or clinically probable Parkinson's disease.
  3. 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.).
  4. Hoehn-Yahr stage ≥2 in the "OFF" state.

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1 GM1
Medicin: GM1
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.
Medicin: GM1
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2, then a 2-week drug holiday.
Medicin: GM1
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2. From Week 3 onward, 1000 mg once weekly until the last dose on Day 78.
Placebo komparator: Cohort 1 Placebo
Medicin: Placebo
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.
Medicin: Placebo
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2, then a 2-week drug holiday.
Medicin: Placebo
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2. From Week 3 onward, 1000 mg once weekly until the last dose on Day 78.
Eksperimentel: Cohort 2 GM1
Medicin: GM1
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.
Medicin: GM1
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2, then a 2-week drug holiday.
Medicin: GM1
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2. From Week 3 onward, 1000 mg once weekly until the last dose on Day 78.
Placebo komparator: Cohort 2 Placebo
Medicin: Placebo
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.
Medicin: Placebo
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2, then a 2-week drug holiday.
Medicin: Placebo
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2. From Week 3 onward, 1000 mg once weekly until the last dose on Day 78.
Eksperimentel: Cohort 3 GM1
Medicin: GM1
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.
Medicin: GM1
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2, then a 2-week drug holiday.
Medicin: GM1
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2. From Week 3 onward, 1000 mg once weekly until the last dose on Day 78.
Placebo komparator: Cohort 3 Placebo
Medicin: Placebo
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.
Medicin: Placebo
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2, then a 2-week drug holiday.
Medicin: Placebo
1000 mg on Day 1, followed by 200 mg once daily from Day 2 to the end of Week 2. From Week 3 onward, 1000 mg once weekly until the last dose on Day 78.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from Baseline in Total "ON" Time without Troublesome Dyskinesia as assessed by 24-hour patient diary cards.
Tidsramme: Baseline, Day 85
Baseline, Day 85

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

9. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GM1-PD-201

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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