A Study to Evaluate the Safety, Tolerability and Efficacy of ILB in Patients With Amyotrophic Lateral Sclerosis
Status:
Terminated
Trial end date:
2019-08-20
Target enrollment:
Participant gender:
Summary
This is a Phase 2a single-centre, open single-arm study in patients with Amyotrophic Lateral
Sclerosis (ALS) of intermediate progression rate. Eligible subjects will be administered
weekly doses of ILB. A total of 5 subcutaneous (s.c.) doses will be administered at the study
clinic.
The study consists of 10 visits; One 2-part screening visit, 5 ILB administration visits, and
3 follow-up visits. Each individual patient's study participation will be 4 months, including
the screening and follow-up visits. Fifteen patients are planned to be included.
The primary objective of the study is to evaluate the safety and tolerability of ILB in
patients diagnosed with ALS.
ILB is a solution for subcutaneous (s.c.) injection in saline solution. The dose administered
will depend on the subject's body weight at the second study visit, prior to the first ILB
administration.
No formal sample size calculation has been performed for this study. The proposed sample size
is considered sufficient in this early phase 2 development to provide adequate information on
the patients. Categorical data will be presented as counts and percentages. Continuous data
will be summarised using descriptive statistics.