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Antisense Oligonucleotide
WVE-004 for Lou Gehrig's Disease (FOCUS-C9 Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Wave Life Sciences Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up period 1 day 1 to period 2 week 24 (end of study)
Awards & highlights
FOCUS-C9 Trial Summary
This trial is studying a new treatment for patients with C9orf72-associated ALS or FTD. The treatment will be given through the spine, and the study will evaluate how well it is tolerated and how it affects the body.
Eligible Conditions
- Lou Gehrig's Disease
- Frontotemporal Dementia
FOCUS-C9 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ period 1 day 1 to period 2 week 24 (end of study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~period 1 day 1 to period 2 week 24 (end of study)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: Proportion of patients with adverse events (AEs)
Secondary outcome measures
Pharmacodynamic: Change from baseline in concentration of poly-GP levels in the CSF
Pharmacokinetic: Concentration of WVE-004 in cerebrospinal fluid (CSF)
FOCUS-C9 Trial Design
4Treatment groups
Experimental Treatment
Group I: WVE-004 (Dose D) or placeboExperimental Treatment2 Interventions
Group II: WVE-004 (Dose C) or placeboExperimental Treatment2 Interventions
Group III: WVE-004 (Dose B) or placeboExperimental Treatment2 Interventions
Group IV: WVE-004 (Dose A) or placeboExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Wave Life Sciences Ltd.Lead Sponsor
12 Previous Clinical Trials
467 Total Patients Enrolled
Medical Director, MDStudy DirectorWave Life Sciences
77 Previous Clinical Trials
16,377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you're taking riluzole for ALS, you need to have been on the same dose for at least 30 days without any changes.If you take riluzole or edaravone for ALS, you must have stopped taking them at least one month before the screening.If you have a combination of symptoms from both ALS (a muscle disease) and FTD (a type of dementia), you need to meet the criteria for both conditions to be eligible for the study.
Research Study Groups:
This trial has the following groups:- Group 1: WVE-004 (Dose B) or placebo
- Group 2: WVE-004 (Dose A) or placebo
- Group 3: WVE-004 (Dose C) or placebo
- Group 4: WVE-004 (Dose D) or placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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