<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04455542</url>
  </required_header>
  <id_info>
    <org_study_id>PUTH2017198</org_study_id>
    <nct_id>NCT04455542</nct_id>
  </id_info>
  <brief_title>Peripheral Neurofilament Levels and Amyotrophic Lateral Sclerosis</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the correlation between peripheral neurofilament levels and clinical subtypes of&#xD;
      amyotrophic lateral sclerosis and the severity of peripheral motor axonal involvement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Amyotrophic lateral sclerosis (ALS) is a kind of neurodegenerative disease that affects upper&#xD;
      and lower motor neurons. In animal model studies have shown that peripheral nerve&#xD;
      degeneration in ALS motor function decline, tip peripheral nerve degeneration is of great&#xD;
      significance for early progress of ALS may be, at the same time analysis showed that the&#xD;
      motor neuron involvement severity and the prognosis of patients with ALS show obvious&#xD;
      negative correlation, so finding biomarkers can reflect the motor neuron axonal degeneration&#xD;
      is of great significance. Neurofilaments is an intermediate fiber specifically expressed in&#xD;
      central and peripheral neurons and can serve as a biomarker for axonal injury, but there is&#xD;
      no evidence now that peripheral neurofilament levels have been associated with severity of&#xD;
      motor axonal involvement in ALS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>level of neurofilament</measure>
    <time_frame>1 year after recruitment</time_frame>
    <description>Venous blood 4 ml was extracted from the three groups of patients for determination of the level of neurofilament.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">103</enrollment>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <arm_group>
    <arm_group_label>LMND-ALS</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UMND-ALS</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FAS and FLS</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LMND-ALS</intervention_name>
    <description>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.</description>
    <arm_group_label>LMND-ALS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>UMND-ALS</intervention_name>
    <description>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.</description>
    <arm_group_label>UMND-ALS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FAS and FLS</intervention_name>
    <description>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.</description>
    <arm_group_label>FAS and FLS</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with lower motor neuron involvement (LMND-ALS), who have visited the Department of&#xD;
        Neurology of the Third Hospital of Beijing Medical University since August 2017, meet the&#xD;
        diagnostic criteria for ALS in 1998.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with lower motor neuron involvement (LMND-ALS), who have visited the&#xD;
             Department of Neurology of the Third Hospital of Beijing Medical University since&#xD;
             August 2017, meet the diagnostic criteria for ALS in 1998. The main clinical&#xD;
             manifestations were muscle weakness with atrophy and bundle fibrillation, the&#xD;
             pyramidal tract sign was relatively mild, and extensive neurogenic damage with CMAP&#xD;
             amplitude decreased could be seen in patients with electromyography.&#xD;
&#xD;
               -  LMND-ALS CMAP amplitude &lt; median array: in line with LMND -ALS inclusion&#xD;
                  criteria, and CMAP amplitude of peripheral motor nerves (CMAP amplitude of the 10&#xD;
                  peripheral motor nerves with the most obvious CMAP amplitude decline was selected&#xD;
                  as the CMAP amplitude for grouping of the patients) was less than the median of&#xD;
                  CMAP amplitude of LMND -ALS group.&#xD;
&#xD;
               -  LMND -ALS CMAP amplitude ≥ median array: meeting LMND -ALS inclusion criteria,&#xD;
                  and CMAP amplitude of peripheral motor nerves (CMAP amplitude of 10 peripheral&#xD;
                  motor nerves with the most obvious CMAP amplitude decline was selected as the&#xD;
                  CMAP amplitude for grouping of the patients) was greater than or equal to the&#xD;
                  median of CMAP amplitude of LMND -ALS group.&#xD;
&#xD;
          -  Patients with upper motor neuron involvement (UMND-ALS): patients with ALS who visited&#xD;
             the Department of Neurology of the Third Hospital of Beijing Medical University since&#xD;
             August 2017 and met the diagnostic criteria for ALS in 1998. The main clinical&#xD;
             manifestations were limb stiffness and spasm, obvious pyramidal tract signs,&#xD;
             relatively mild muscle atrophy and fasciculation, and no significant decrease in&#xD;
             amplitude of electromyography CMAP.&#xD;
&#xD;
          -  Patients with ALS with flail arm syndrome (FAS) and flail leg syndrome (FLS): patients&#xD;
             with ALS who met the diagnostic criteria for ALS in 1998 and visited the Department of&#xD;
             Neurology of the Third Hospital of Beijing Medical University since August 2017. The&#xD;
             clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more&#xD;
             than 12 months, and the main manifestations were lower motor neuron involvement signs&#xD;
             such as muscle weakness and atrophy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Merging other nervous system degenerative diseases (Alzheimer's disease, Parkinson's&#xD;
             disease, multiple system atrophy, etc.) to take off the sheath, central nervous system&#xD;
             disease, multiple sclerosis, optic myelitis spectrum disorders), peripheral neuropathy&#xD;
             (GBS, chronic inflammatory more nerve root sheath sex mental derangement, hereditary&#xD;
             peripheral neuropathy, diabetic peripheral neuropathy, vice tumor peripheral&#xD;
             neuropathy, secondary to autoimmune diseases ), into the group within a month before&#xD;
             the cerebrovascular disease or cerebral or spinal surgery patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dongsheng Fan, MD.PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Amyotrophic Lateral Sclerosis; Neurofilament levels</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04455542
org study id: PUTH2017198
nct id: NCT04455542
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the correlation between peripheral neurofilament levels and clinical subtypes of
      amyotrophic lateral sclerosis and the severity of peripheral motor axonal involvement.
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.
observational model: Case-Only
time perspective: Prospective
measure: level of neurofilament
time frame: 1 year after recruitment
description: Venous blood 4 ml was extracted from the three groups of patients for determination of the level of neurofilament.
arm group label: LMND-ALS
description: 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.
arm group label: UMND-ALS
description: 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.
arm group label: FAS and FLS
description: 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
intervention type: Other
intervention name: LMND-ALS
description: 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.
arm group label: LMND-ALS
intervention type: Other
intervention name: UMND-ALS
description: 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.
arm group label: UMND-ALS
intervention type: Other
intervention name: FAS and FLS
description: 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.
arm group label: FAS and FLS
Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dongsheng Fan, MD.PHD
role: Principal Investigator
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Sclerosis
sharing ipd: No