Amyotrophic Lateral Sclerosis (ALS)
Conditions
Interventions
Product Name: ILB
Product Code: ILB
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ILB
CAS Number: 9011-18-1
Sponsors
TikoMed AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent for participation in the study. 2. Clinical diagnosis of Amyotrophic Lateral Sclerosis. 3. Male or female patients between 18-80 years of age (inclusive). 4. Forced Vital Capacity (FVC) >/=65 % of predicted value for gender, height and age at screening. 5. Evaluated with ALSFRS-R and Norris clinical rating scales for at least the past 4 weeks before study drug administration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Unable to understand information about the trial or are expected not to collaborate with the study team. 2. Concurrent serious disease, other than ALS. 3. Pregnancy. 4. Patients of child-bearing potential not willing to use adequate double contraception with <1 % failure rate after the screening visit until the last visit. 5. Addiction to drugs or alcohol. 6. Confirmed HIV, Hepatitis B or C. 7. Known bleeding disorders or abnormal bleeding events. 8. Treatment with anticoagulant drugs warfarin and novel oral anticoagulants (NOAC) within the last 14 days prior to screening. 9. Treatment with Riluzole or Lamotrigine within the last 28 days prior to study drug administration. 10. Hypersensitivity to dextran sulfate 11. Poor venous access. 12. Patients with clinically significant abnormal PK-INR, fibrinogen, von Willebrand factor and activated partial thromboplastin time (APTT) at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study safety and tolerability of subcutaneously administered ILB in patients diagnosed with ALS.;Secondary Objective: To evaluate efficacy of subcutaneously administered ILB in patients diagnosed with ALS.; Primary end point(s): To evaluate safety by: * Adverse events. * Physical exam. * Vital signs: blood pressure, heart rate, and body temperature. * ECG assessment. * Haematology and clinical chemistry lab tests. ;Timepoint(s) of evaluation of this end point: At 9 visits over 4 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate efficacy by: * ALSFRS-R functional rating scale. * Norris functional rating scale. * Plasma and CSF-analysis for biomarker Neurofilament light chain (NFL). * Plasma, blood and serum analysis for biomarkers for neurological disorders. * Respiratory function (FVC). * Evaluation of quality of Life and autonomous symptoms. * Levels of hepatocyte growth factor, pharmacokinetics and activated partial thromboplastin time. ;Timepoint(s) of evaluation of this end point: At specific timepoints during up to 9 visits over several months. | — |
Countries
Sweden
Contacts
Public ContactLars Bruce
TikoMed AB
Outcome results
None listed