Amyotrophic Lateral SclerosisNCT04455542
Peripheral Neurofilament Levels and Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the correlation between peripheral neurofilament levels and clinical subtypes of amyotrophic lateral sclerosis and the severity of peripheral motor axonal involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- LMND-ALS, UMND-ALS and FAS and FLS
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 May 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lower motor neuron involvement (LMND-ALS), who have visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017, meet the diagnostic criteria for ALS in 1998.
Who may be able to join
- Patients with lower motor neuron involvement (LMND-ALS), who have visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017, meet the diagnostic criteria for ALS in 1998. The main clinical manifestations were muscle weakness with atrophy and bundle fibrillation, the pyramidal tract sign was relatively mild, and extensive neurogenic damage with CMAP amplitude decreased could be seen in patients with electromyography.
- LMND-ALS CMAP amplitude < median array: in line with LMND -ALS inclusion criteria, and CMAP amplitude of peripheral motor nerves (CMAP amplitude of the 10 peripheral motor nerves with the most obvious CMAP amplitude decline was selected as the CMAP amplitude for grouping of the patients) was less than the median of CMAP amplitude of LMND -ALS group.
- LMND -ALS CMAP amplitude ≥ median array: meeting LMND -ALS inclusion criteria, and CMAP amplitude of peripheral motor nerves (CMAP amplitude of 10 peripheral motor nerves with the most obvious CMAP amplitude decline was selected as the CMAP amplitude for grouping of the patients) was greater than or equal to the median of CMAP amplitude of LMND -ALS group.
- Patients with upper motor neuron involvement (UMND-ALS): patients with ALS who visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017 and met the diagnostic criteria for ALS in 1998. The main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP.
- Patients with ALS with flail arm syndrome (FAS) and flail leg syndrome (FLS): patients with ALS who met the diagnostic criteria for ALS in 1998 and visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017. The clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy.
Who cannot join
- Merging other nervous system degenerative diseases (Alzheimer's disease, Parkinson's disease, multiple system atrophy, etc.) to take off the sheath, central nervous system disease, multiple sclerosis, optic myelitis spectrum disorders), peripheral neuropathy (GBS, chronic inflammatory more nerve root sheath sex mental derangement, hereditary peripheral neuropathy, diabetic peripheral neuropathy, vice tumor peripheral neuropathy, secondary to autoimmune diseases ), into the group within a month before the cerebrovascular disease or cerebral or spinal surgery patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Correlation Between Peripheral Neurofilament Levels and Clinical Subtypes of Amyotrophic Lateral Sclerosis and the Severity of Peripheral Motor Axonal Involvement.
To evaluate the correlation between peripheral neurofilament levels and clinical subtypes of amyotrophic lateral sclerosis and the severity of peripheral motor axonal involvement.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a kind of neurodegenerative disease that affects upper and lower motor neurons. In animal model studies have shown that peripheral nerve degeneration in ALS motor function decline, tip peripheral nerve degeneration is of great significance for early progress of ALS may be, at the same time analysis showed that the motor neuron involvement severity and the prognosis of patients with ALS show obvious negative correlation, so finding biomarkers can reflect the motor neuron axonal degeneration is of great significance. Neurofilaments is an intermediate fiber specifically expressed in central and peripheral neurons and can serve as a biomarker for axonal injury, but there is no evidence now that peripheral neurofilament levels have been associated with severity of motor axonal involvement in ALS.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- LMND-ALS, UMND-ALS, FAS and FLS
- Keywords
- Amyotrophic Lateral Sclerosis; Neurofilament levels
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMND-ALSOther
in line with LMND -ALS inclusion criteria, and CMAP amplitude of peripheral motor nerves (CMAP amplitude of the 10 peripheral motor nerves with the most obvious CMAP amplitude decline was selected as the CMAP amplitude for grouping of the patients) was less than the median of CMAP amplitude of LMND -ALS group.
UMND-ALSOther
The main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP.
FAS and FLSOther
The clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy.
| Study group | Role | What they receive |
|---|---|---|
| LMND-ALS | The main clinical manifestations were muscle weakness with atrophy and bundle fibrillation, the pyramidal tract sign was relatively mild, and extensive neurogenic damage with CMAP amplitude decreased could be seen in patients with electromyography. Receives: Other: LMND-ALS | |
| UMND-ALS | The main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP. Receives: Other: UMND-ALS | |
| FAS and FLS | The clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy Receives: Other: FAS and FLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of neurofilament
Venous blood 4 ml was extracted from the three groups of patients for determination of the level of neurofilament.
Measured: 1 year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Aug 2017
- Primary completion1 May 2019
- Study completion1 May 2019
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 Peking University Third 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongsheng Fan, MD.PHD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455542
- Sponsor's protocol ID
- PUTH2017198
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Correlation Between Peripheral Neurofilament Levels and Clinical Subtypes of Amyotrophic Lateral Sclerosis and the Severity of Peripheral Motor Axonal Involvement.
- ClinicalTrials.gov ID
- NCT04455542
- Acronym / sponsor ID
- PUTH2017198
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis; Neurofilament levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 2 Jul 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.
To evaluate the correlation between peripheral neurofilament levels and clinical subtypes of amyotrophic lateral sclerosis and the severity of peripheral motor axonal involvement.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a kind of neurodegenerative disease that affects upper and lower motor neurons. In animal model studies have shown that peripheral nerve degeneration in ALS motor function decline, tip peripheral nerve degeneration is of great significance for early progress of ALS may be, at the same time analysis showed that the motor neuron involvement severity and the prognosis of patients with ALS show obvious negative correlation, so finding biomarkers can reflect the motor neuron axonal degeneration is of great significance. Neurofilaments is an intermediate fiber specifically expressed in central and peripheral neurons and can serve as a biomarker for axonal injury, but there is no evidence now that peripheral neurofilament levels have been associated with severity of motor axonal involvement in ALS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LMND-ALS | – | Other: LMND-ALSThe main clinical manifestations were muscle weakness with atrophy and bundle fibrillation, the pyramidal tract sign was relatively mild, and extensive neurogenic damage with CMAP amplitude decreased could be seen in patients with electromyography. |
| UMND-ALS | – | Other: UMND-ALSThe main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP. |
| FAS and FLS | – | Other: FAS and FLSThe clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower motor neuron involvement (LMND-ALS), who have visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017, meet the diagnostic criteria for ALS in 1998.
Key inclusion criteria (5 listed)
- Patients with lower motor neuron involvement (LMND-ALS), who have visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017, meet the diagnostic criteria for ALS in 1998. The main clinical manifestations were muscle weakness with atrophy and bundle fibrillation, the pyramidal tract sign was relatively mild, and extensive neurogenic damage with CMAP amplitude decreased could be seen in patients with electromyography.
- Patients with upper motor neuron involvement (UMND-ALS): patients with ALS who visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017 and met the diagnostic criteria for ALS in 1998. The main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP.
- Patients with ALS with flail arm syndrome (FAS) and flail leg syndrome (FLS): patients with ALS who met the diagnostic criteria for ALS in 1998 and visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017. The clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy.
Key exclusion criteria (1 listed)
- Merging other nervous system degenerative diseases (Alzheimer's disease, Parkinson's disease, multiple system atrophy, etc.) to take off the sheath, central nervous system disease, multiple sclerosis, optic myelitis spectrum disorders), peripheral neuropathy (GBS, chronic inflammatory more nerve root sheath sex mental derangement, hereditary peripheral neuropathy, diabetic peripheral neuropathy, vice tumor peripheral neuropathy, secondary to autoimmune diseases ), into the group within a month before the cerebrovascular disease or cerebral or spinal surgery patients.
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 |
|---|---|---|
| LMND-ALSin line with LMND -ALS inclusion criteria, and CMAP amplitude of peripheral motor nerves (CMAP amplitude of the 10 peripheral motor nerves with the most obvious CMAP amplitude decline was selected as the CMAP amplitude for grouping of the patients) was less than the median of CMAP amplitude of LMND -ALS group. | Other | LMND-ALS |
| UMND-ALSThe main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP. | Other | UMND-ALS |
| FAS and FLSThe clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy. | Other | FAS and FLS |
Primary outcome
level of neurofilament
Time frame: 1 year after recruitment
Venous blood 4 ml was extracted from the three groups of patients for determination of the level of neurofilament.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Dongsheng Fan, MD.PHD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Peking University Third 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of neurofilament (time frame: 1 year after recruitment). 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 2 Jul 2020.