Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365216
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-09
Brief Title:
ALS Phase II Study of NX210c
Sponsor:
Axoltis Pharma
Organization:
Axoltis Pharma
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Multicentric Phase II Study in Adult Patients With Amyotrophic Lateral Sclerosis ALS to Assess Efficacy Safety Tolerability and Pharmacokinetics of Multiple Intravenous Infusions of NX210c
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEALS
Brief Summary:
This study will investigate the efficacy safety tolerability and pharmacokinetics PK of multiple intravenous infusions of NX210c at two dose levels in patients with Amyotrophic lateral sclerosis ALS
Detailed Description:
Amyotrophic lateral sclerosis ALS is a fatal neurodegenerative disease that predominantly affects motor neurons of both the brain and the spinal cord This leads to muscular atrophy and paralysis with the majority of patients succumbing to respiratory failure 3-4 years from symptom onset To date therapeutic options for ALS are limited and there is no curative treatment Management of ALS is otherwise supportive and palliative
There is strong evidence for blood-brain and blood-spinal cord barrier dysfunction in the early stages of ALS Preclinical in vitro and in vivo data have shown that NX210c exhibits important properties that may be suitable for the treatment of neurological disorders in humans ie blood-brain barrier BBB integrity restoration neurotransmission enhancement and neuroprotection
Based on the safety data collected in a first-in-human single ascending dose study and a multiple ascending dose MAD study in healthy elderly subjects NX210c has been demonstrated to be well tolerated and without safety concerns
There is strong evidence for blood-brain and blood-spinal cord barrier dysfunction in the early stages of ALS Preclinical in vitro and in vivo data have shown that NX210c exhibits important properties that may be suitable for the treatment of neurological disorders in humans ie blood-brain barrier BBB integrity restoration neurotransmission enhancement and neuroprotection
Based on the safety data collected in a first-in-human single ascending dose study and a multiple ascending dose MAD study in healthy elderly subjects NX210c has been demonstrated to be well tolerated and without safety concerns
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508895-13-00 | CTIS | None | None |