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Clinical Trials/ISRCTN83738603
ISRCTN83738603
Completed
Phase 2

A Phase II pilot safety and tolerability study of ILB in patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS)

niversity of Birmingham0 sites11 target enrollmentNovember 5, 2019
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ConditionsAmyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND)Nervous System Diseases

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND)
Sponsor
niversity of Birmingham
Enrollment
11
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38990927/ (added 15/07/2024)

Registry
who.int
Start Date
November 5, 2019
End Date
April 30, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients \> \= 18 years and who have provided written informed consent to participate in the study
  • •2\. Prior to trial entry patients will have a definite diagnosis of ALS according to El Escorial Criteria. All patients will demonstrate either:
  • •2\.1 Presence of UMN (increased tone, brisk reflexes) as well as LMN (weakness, wasting and fasciculation) signs in the bulbar region and at least two of the other spinal regions (cervical, thoracic or lumbosacral) OR
  • •2\.2 Presence of UMN and LMN signs in all three spinal regions (cervical, thoracic or lumbosacral)
  • •3\. Electrophysiological tests (Electromyography (EMG) / Nerve Conduction Study (NCS)) that supports the diagnosis of Motor Neurone Disease (MND)
  • •4\. Forced Vital Capacity (FVC) \> \= 50% of predicted value for gender, height and age at screening and a mean Sniff Nasal Inspiratory Pressure (SNIP) \> \= 50% of predicted value for age
  • •5\. Adequate haematological function (Hb\> \= 10g/dl), absolute neutrophil count \> \= 1\.5x109/L and a platelet count \> \= 60 x109/L
  • •6\. International Normalised Ratio (INR) \< \= 1\.5, aPTT 30 – 40 seconds, PT 11\-13\.5 seconds
  • •7\. Patient willing and able to comply with scheduled visits, treatment plan and other study procedures.
  • •8\. Patients taking Riluzole must have discontinued treatment \> \= 28 days prior to study entry (and following consent to take part in the study)

Exclusion Criteria

  • •1\. Patients classified as either probable or possible ALS according to El Escorial Criteria
  • •2\. Subjects in whom other causes of neuromuscular weakness have not been excluded.
  • •3\. Assisted ventilation of any type within 3 months before the screening visit or at screening
  • •4\. Patients requiring Radiologically Inserted Gastrostomy (RIG) or Percutaneous Endoscopic Gastroscopy (PEG) feeding
  • •5\. Involvement in any other interventional study involving use of another IMP or biological product within 3 months of screening
  • •6\. Any use of antioxidants, edaravone, tirasemtiv or CK\-2127107 within 1 month before the screening visit.
  • •7\. Any botulinum toxin use within 3 months before the screening visit
  • •8\. Any form of stem cell or gene therapy for the treatment of amyotrophic lateral sclerosis (ALS)
  • •9\. Neuroimaging of brain and cervical spine with Magnetic Resonance Imaging (MRI) indicating compressive myelopathy as an alternate diagnosis
  • •10\. Laboratory examinations including Acetylcholine receptor (AChR) antibodies and Muscle Specific Kinase (MuSK) antibodies to exclude Bulbar onset Myasthenia gravis from Bulbar onset Motor Neurone disease as an alternate diagnosis and Antinuclear Antibodies (ANA), Anti\-neutrophil cytoplasmic antibodies (ANCA), Extractable Nuclear Antigen (ENA) antibodies, Creatine Kinase (CK), electrophoresis and immunoglobulin indicating an alternate diagnosis for muscle disease like Myositis

Outcomes

Primary Outcomes

Not specified

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