Clinical Trials Logo
  1. Home
  2. Amyotrophic Lateral Sclerosis
  3. NCT03613571

A Study to Evaluate the Safety, Tolerability and Efficacy of ILB in Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
A Single-centre, Open Single-arm Study Where the Safety, Tolerability and Efficacy of Subcutaneously Administered ILB Will be Evaluated in Patients With Amyotrophic Lateral Sclerosis

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03613571
Study type Interventional
Source TikoMed AB
Contact
Status Terminated
Phase Phase 2
Start date August 15, 2018
Completion date August 20, 2019
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04428775 - A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease Phase 2
Recruiting NCT04998305 - TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps Phase 1/Phase 2
Recruiting NCT05951556 - Telehealth Implementation of Brain-Computer Interface N/A
Terminated NCT04579666 - MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT04082832 - CuATSM Compared With Placebo for Treatment of ALS/MND Phase 2/Phase 3
Completed NCT01925196 - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
Completed NCT02496767 - Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year Phase 3
Recruiting NCT04816227 - Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
Active, not recruiting NCT04494256 - A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation Phase 1/Phase 2
Completed NCT03706391 - Study of ALS Reversals 4: LifeTime Exposures
Recruiting NCT04882904 - Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part. N/A
Completed NCT04557410 - Open Label Study: Treatment of ALS Fatigue With PolyMVA Phase 1
Active, not recruiting NCT04948645 - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis Phase 1
Not yet recruiting NCT04089696 - Validation of the "ExSpiron©" in Patients With ALS N/A
Not yet recruiting NCT05860244 - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients Phase 2
Not yet recruiting NCT06450691 - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts N/A
Not yet recruiting NCT04220190 - RAPA-501 Therapy for ALS Phase 2/Phase 3
Recruiting NCT02917681 - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis Phase 1/Phase 2
Active, not recruiting NCT03067857 - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease Phase 1/Phase 2
Recruiting NCT02874209 - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis N/A