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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06903286




Registration number
NCT06903286
Ethics application status
Date submitted
24/03/2025
Date registered
30/03/2025

Titles & IDs
Public title
Extension Study of Participants From SPG302-ALS-001
Scientific title
An Open-label Extension of SPG302-ALS-001 Study to Evaluate the Long-term Safety and Efficacy of Daily Oral SPG302 Treatment in Participants With Amyotrophic Lateral Sclerosis
Secondary ID [1] 0 0
SPG302-ALS-002 OLE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis (ALS) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SPG302

Experimental: Experimental: Open Label Extension - Active SPG302 to be administered to adult participants with ALS who completed initial study. Dose to be administered to be dose received during previous study.


Treatment: Drugs: SPG302
Open label SPG302 to be self-administered daily by eligible participants for 52 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment emergent adverse events and serious adverse events
Timepoint [1] 0 0
Up to 52 weeks
Primary outcome [2] 0 0
C-SSRS (Columbia Suicide Severity Rating Scale)
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [1] 0 0
Change in the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) scores
Timepoint [1] 0 0
up to 52 weeks
Secondary outcome [2] 0 0
Change in Edinburgh Cognitive and Behavioural ALS Screen (ECAS)
Timepoint [2] 0 0
up to 52 weeks
Secondary outcome [3] 0 0
Changes from baseline in neurofilament light biomarker (NfL)
Timepoint [3] 0 0
up to 52 weeks.

Eligibility
Key inclusion criteria
• Must have participated in all study activities of SPG302-ALS-001, the parent study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to reliably and regularly swallow whole oral medications on a daily basis.
* Medical conditions that investigator or sponsor determine would interfere with participation in clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
29/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Macquarie University - North Ryde
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spinogenix
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Info Spinogenix
Address 0 0
Country 0 0
Phone 0 0
+61 2 8382 4977
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06903286