A single-center, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis.

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis (ALS); Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-005065-47-SE
• Lead Sponsor: TikoMed AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified