NCT02794857

Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation

Completed Phase 2 Last updated 7 May 2018

What this trial tests

Phase 2 trial testing NP001 in Amyotrophic Lateral Sclerosis in 138 participants. Completed in 12 December 2017.

Timeline

29 August 2016

Primary endpoint
12 December 2017

12 December 2017

Quick facts

Lead sponsor	Neuraltus Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	138
Start date	29 August 2016
Primary completion	12 December 2017
Estimated completion	12 December 2017
Sites	22 locations across Canada, United States

Drugs / interventions tested

• NP001 — full drug profile →
• Placebo

Conditions studied

• Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Neuraltus Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 21 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates NP001 in patients with amyotrophic lateral sclerosis (ALS) and evidence of systemic inflammation. Half of participants will receive NP001 and the other half will receive placebo.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of Neuroinflammation in Amyotrophic Lateral Sclerosis: Cellular Mechanisms and Therapeutic Implications.
   Liu J, Wang F. · · 2017 · cited 261× · PMID 28871262 · DOI 10.3389/fimmu.2017.01005
2. ALS blood expression profiling identifies new biomarkers, patient subgroups, and evidence for neutrophilia and hypoxia.
   Swindell WR, Kruse CPS, List EO, Berryman DE, et al · · 2019 · cited 57× · PMID 31118040 · DOI 10.1186/s12967-019-1909-0
3. New developments and opportunities in drugs being trialed for amyotrophic lateral sclerosis from 2020 to 2022.
   Jiang J, Wang Y, Deng M. · · 2022 · cited 48× · PMID 36518658 · DOI 10.3389/fphar.2022.1054006
4. Blood-Brain Barrier Driven Pharmacoresistance in Amyotrophic Lateral Sclerosis and Challenges for Effective Drug Therapies.
   Mohamed LA, Markandaiah S, Bonanno S, Pasinelli P, et al · · 2017 · cited 25× · PMID 28779378 · DOI 10.1208/s12248-017-0120-6
5. Phase 2B randomized controlled trial of NP001 in amyotrophic lateral sclerosis: Pre-specified and post hoc analyses.
   Miller RG, Zhang R, Bracci PM, Azhir A, et al · · 2022 · cited 24× · PMID 35098554 · DOI 10.1002/mus.27511
6. Unraveling the Heterogeneity of ALS-A Call to Redefine Patient Stratification for Better Outcomes in Clinical Trials.
   Tzeplaeff L, Jürs AV, Wohnrade C, Demleitner AF. · · 2024 · cited 21× · PMID 38474416 · DOI 10.3390/cells13050452
7. Microglial crosstalk with astrocytes and immune cells in amyotrophic lateral sclerosis.
   Calafatti M, Cocozza G, Limatola C, Garofalo S. · · 2023 · cited 21× · PMID 37564648 · DOI 10.3389/fimmu.2023.1223096
8. The Effectiveness of NP001 on the Long-Term Survival of Patients with Amyotrophic Lateral Sclerosis.
   Forrest BD, Goyal NA, Fleming TR, Bracci PM, et al · · 2024 · cited 6× · PMID 39457678 · DOI 10.3390/biomedicines12102367