The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of Aleeto in the treatment of patients with multiple system atrophy (MSA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 30 years ≤ 75 years of age, regardless of sex; 2.Clinically confirmed or clinically probable MSA-P; 3.Poor response to levodopa; 4.MSA-related motor symptom onset ≤5 years at first visit; 5.Walking ≥10 meters independently or with a walking aid; 6.Expected survival of ≥1 year, as determined by the investigator; 7.Signed informed consent.

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Weiqi Chen, M.D.
weiqichen@aliyun.com
8615652813380
Backup
Lei Guo
guolei53@aliyun.com
8619801237597
Time Frame
Start Date: 2025-05-31
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Intervention group
Intrathecal administration combined with intravenous administration of Aleeto of Aleeto was given to each MSA patient in the intervention group, with intrathecal administration on days 1, 31 and 61 and intravenous administration on days 2 to 14, 32 to 44±3 and 62 to 74±5, and treatment was given once a day.~intrathecal administration: 8 mL sodium chloride injection + Aleeto (130 μg/branch) for intrathecal administration, which was completed in about 5 minutes; intravenous administration: Aleeto (130 μg/branch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous Aleeto administration (14 consecutive days of Aleeto 130 μg qd i.v. in each phase).
No_intervention: Control group
Each MSA patient in the blank control group received only basic treatment with no trial-related treatment.~After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous Aleeto administration (14 consecutive days of Aleeto 130 μg qd i.v. in each phase).
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov