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NCT04391361

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

Status unknown Phase 2 Last updated 14 October 2020
What this trial tests

Phase 2 trial testing Scopolamine, atropine, edaravone and dexmedetomidine in Amyotrophic Lateral Sclerosis in 30 participants. Status unknown.

Timeline
1 November 2020
Primary endpoint
30 September 2023
31 October 2023

Quick facts

Lead sponsorRuijin Hospital
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment30
Start date1 November 2020
Primary completion30 September 2023
Estimated completion31 October 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Ruijin Hospital

Who can join

Adults 30 to 65, any sex, with Amyotrophic Lateral Sclerosis or Respiratory Function. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Role of Edaravone as a Treatment Option for Patients with Amyotrophic Lateral Sclerosis.
    Cho H, Shukla S. · · 2020 · cited 79× · PMID 33396271 · DOI 10.3390/ph14010029
  2. Current Drug Repurposing Strategies for Rare Neurodegenerative Disorders.
    Shah S, Dooms MM, Amaral-Garcia S, Igoillo-Esteve M. · · 2021 · cited 32× · PMID 34992533 · DOI 10.3389/fphar.2021.768023
  3. Targeting Emerging Pathogenic Mechanisms by Natural Molecules as Potential Therapeutics for Neurodegenerative Diseases.
    Dou Y, Zhao D. · · 2022 · cited 3× · PMID 36365106 · DOI 10.3390/pharmaceutics14112287

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

Other Ruijin Hospital trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing