Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2
The primary objective is to evaluate in ALS patients the regulatory T cell early response to two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days comparatively to placebo.
This is a phase II study on ld-IL-2 as a therapeutic agent for ALS which aims at defining
the activity and safety of a range a doses for subsequent use of the best dose in a phase
II/III trial. For ethical reasons, ld-IL-2 must be tested as an add-on therapy to riluzole
hence all patients will need to be treated with riluzole for at least three months prior to
entry. A randomized (1:1:1), placebo-controlled, double-blind, parallel group trial will be
carried out to assess ld-IL-2 activity on regulatory T cells and immuno-inflammatory markers
in ALS patients treated for 3 months (5 days every four weeks repeated three times).
The secondary objectives of this study are:
A. To evaluate maintenance of Tcell response after three repeated 5-day courses at one
course every four weeks for 12 weeks.
B. To evaluate the safety of ld-IL-2 therapy in an ALS population, with an overall follow-up
of 6 months (up to 15 weeks after last administration); C. To evaluate functional changes
throughout the study; D. To evaluate changes in other pre-defined blood cytology parameters,
and a blood biomarker for axonal damage.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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 |
NCT04220190 -
RAPA-501 Therapy for ALS
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT06450691 -
Modeling Amyotrophic Lateral Sclerosis With Fibroblasts
|
N/A | |
| 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 |