Amyotrophic Lateral SclerosisPhase 2NCT04391361
The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS
A Phase 2 study testing Scopolamine, atropine, edaravone and dexmedetomidine and Edaravone in people with Amyotrophic Lateral Sclerosis and Respiratory Function, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Respiratory Function, Scopolamine
- What is being tested?
- Scopolamine, atropine, edaravone and dexmedetomidine and Edaravone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should voluntarily participate in the experiment by signing an informed consent form.
- Patients should comply with the research process and cooperate with the interventions applied throughout the experiment.
- Patients should be between 30 and 65 years of age, and both sexes are acceptable.
- Patients should comply with the diagnostic criteria and exclusion criteria for amyotrophic lateral sclerosis in the Chinese Guidelines for the Diagnosis and Treatment of Amyotrophic Lateral Sclerosis developed by the Chinese Society of Neurology of the Chinese Medical Association in 2012.
- Patient's amyotrophic lateral sclerosis history must not exceed 5 years.
- ALS functional scale score (ALSFRS-R) should be ≥ 2 points for each patients.
Who cannot join
- Patients with cardiac conduction block, severe ventricular insufficiency, severe hepatorenal insufficiency and severe, progressive or uncontrolled major organ and systemic disease.
- High or low blood pressure: systolic blood pressure >150 or <110 mmHg; bradycardia (<60 beats per minute).
- Patients with ventilator-assisted ventilation.
- Patients who are allergic to research intervention drugs.
- Patients with obvious signs of dementia.
- Female patients who are pregnant or breastfeeding or who have a plan to become pregnant in the near future.
- Persons with other psychiatric disorders that may affect the assessment of their condition.
- Severely obese patients (BMI >35kg/m2).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jun Liu, Professor, 64370045 ext. +86-021, jly0520@hotmail.com
About this study
Official title: The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral Sclerosis
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.
- Being tested
- Scopolamine, atropine, edaravone and dexmedetomidine, Edaravone
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scopolamine, atropine, edaravone and dexmedetomidineDrug
The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.
EdaravoneDrug
The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| trial group | Experimental | Not described Receives: Drug: Scopolamine, atropine, edaravone and dexmedetomidine |
| control group | Placebo comparator | Not described Receives: Drug: Edaravone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective
Forced expiratory volume in one second (FVC%) or ALS functional rating scale score (ALSFR, minimum score: 0, maximum score: 48, higher score is related to a better outcome) was elevated.
Measured: 48 weeks
Ineffective
Forced expiratory volume in one second (FVC%) or ALS functional rating scale score (ALSFR, minimum score: 0, maximum score: 48, higher score is related to a better outcome) was decreased or remained unchanged.
Measured: 48 weeks
Secondary outcomes (2)
Effective
Partial pressure of oxygen (PO2), maximum displacement of the hyoid or the modified Norris scale score (minimum score: 0, maximum score: 100, higher score is related to a better outcome) was elevated or partial pressure of carbon dioxide (PCO2) was decreased or remained unchanged.
Measured: 48 weeks
Ineffective
Partial pressure of carbon dioxide (PCO2) was elevated, or partial pressure of oxygen (PO2), maximum displacement of the hyoid or the modified Norris scale score (minimum score: 0, maximum score: 100, higher score is related to a better outcome) was decreased or remained unchanged.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Liu, Professor, Study chair, Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391361
- Sponsor's protocol ID
- lj11128
- Status last verified
- Oct 2020
- First submitted
- 13 May 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) was available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT04391361
- Acronym / sponsor ID
- lj11128
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | Experimental | Drug: Scopolamine, atropine, edaravone and dexmedetomidine |
| control group | Placebo comparator | Drug: Edaravone |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients should voluntarily participate in the experiment by signing an informed consent form.
- Patients should comply with the research process and cooperate with the interventions applied throughout the experiment.
- Patients should be between 30 and 65 years of age, and both sexes are acceptable.
- Patients should comply with the diagnostic criteria and exclusion criteria for amyotrophic lateral sclerosis in the Chinese Guidelines for the Diagnosis and Treatment of Amyotrophic Lateral Sclerosis developed by the Chinese Society of Neurology of the Chinese Medical Association in 2012.
- Patient's amyotrophic lateral sclerosis history must not exceed 5 years.
Key exclusion criteria (8 listed)
- Patients with cardiac conduction block, severe ventricular insufficiency, severe hepatorenal insufficiency and severe, progressive or uncontrolled major organ and systemic disease.
- High or low blood pressure: systolic blood pressure >150 or <110 mmHg; bradycardia (<60 beats per minute).
- Patients with ventilator-assisted ventilation.
- Patients who are allergic to research intervention drugs.
- Patients with obvious signs of dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scopolamine, atropine, edaravone and dexmedetomidineThe patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline. | Drug | trial group |
| EdaravoneThe patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group. | Drug | control group |
Primary outcome
Effective
Time frame: 48 weeks
Forced expiratory volume in one second (FVC%) or ALS functional rating scale score (ALSFR, minimum score: 0, maximum score: 48, higher score is related to a better outcome) was elevated.
Ineffective
Time frame: 48 weeks
Forced expiratory volume in one second (FVC%) or ALS functional rating scale score (ALSFR, minimum score: 0, maximum score: 48, higher score is related to a better outcome) was decreased or remained unchanged.
2 secondary outcomes
Effective
Time frame: 48 weeks
Ineffective
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No. No individual participant data (IPD) was available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Liu, Professor study chair
Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Scopolamine, atropine, edaravone and dexmedetomidine and Edaravone in people with Amyotrophic Lateral Sclerosis and Respiratory Function, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, Professor (64370045 ext. +86-021, jly0520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.