NCT04391361

The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS

The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral Sclerosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Thirty cases of amyotrophic lateral sclerosis patients were recruited from the neurology department of Ruijin Hospital, the pain department and the encephalopathy center of Luwan Branch of Ruijin Hospital. After the informed consent was signed, they were divided into a trial group and a control group. Each group contains 15 cases. The patients in the control group was treated with edaravone dissolved in saline during hospitalization, while the patients in the trial group was treated with edaravone, scopolamine, atropine and dexmedetomidine. Both groups of subjects were treated for 7 days within 3 weeks, followed by a buffer period of 3 weeks for observation, which was one treatment course. The total treatment protocol contains 3 treatment courses (or 18 weeks). Patients with amyotrophic lateral sclerosis were evaluated before treatment and 6, 12, 18, 24, 36, 48 weeks after treatment. The observations include whether the functional scores of patients with amyotrophic lateral sclerosis, Norris amyotrophic lateral sclerosis score, amyotrophic lateral sclerosis self-score, forced expiratory volume in one second, partial pressure of oxygen and maximum displacement of the hyoid were superior to those before treatment, and whether the partial pressure of carbon dioxide was inferior to those before treatment. Study hypothesis: Cholinergic receptor blocking therapy for amyotrophic lateral sclerosis is safe and effective in improving motor function and delaying disease progression in patients with amyotrophic lateral sclerosis.

Conditions

• Amyotrophic Lateral Sclerosis
• Respiratory Function
• Scopolamine

Interventions

Type	Name	Description
DRUG	Scopolamine, atropine, edaravone and dexmedetomidine	The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.
DRUG	Edaravone	The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-09-30
• Completion: 2023-10-31
• First posted: 2020-05-18
• Last updated: 2020-10-14

Locations

1 site across 1 country: China