← Back to Search

Antisense Oligonucleotide

BIIB078 for Amyotrophic Lateral Sclerosis

Phase 1

Waitlist Available

Research Sponsored by Biogen

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 baseline up to day 785

Awards & highlights

Study Summary

This trial is testing a new drug for people with a specific type of ALS. The goal is to see if it is safe and tolerated over the long term. They will also be looking at how this new drug is processed by the body.

Eligible Conditions

ALS (Amyotrophic Lateral Sclerosis)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 785

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 785

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 785 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events (AEs)

Number of Participants with Serious Adverse Events (SAEs)

Secondary outcome measures

Cerebrospinal Fluid (CSF) concentration of BIIB078

Serum concentration of BIIB078

Trial Design

4Treatment groups

Experimental Treatment

Group I: Possible Cohort D: BIIB078 Fourth DosageExperimental Treatment1 Intervention

BIIB078 will be administered as 3 doses during the loading period, approximately 2 weeks apart, and maintenance doses, approximately 4 weeks apart, via IT infusion.

Group II: Cohort C: BIIB078 Third DosageExperimental Treatment1 Intervention

BIIB078 will be administered as 3 doses during the loading period, approximately 2 weeks apart, and maintenance doses, approximately 4 weeks apart, via IT infusion.

Group III: Cohort B: BIIB078 Second DosageExperimental Treatment1 Intervention

BIIB078 will be administered as 3 doses during the loading period, approximately 2 weeks apart, and maintenance doses, approximately 4 weeks apart, via IT infusion.

Group IV: Cohort A: BIIB078 First DosageExperimental Treatment1 Intervention

BIIB078 will be administered as 3 doses during the loading period, approximately 2 weeks apart, and maintenance doses, approximately 4 weeks apart, via IT infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BIIB078

2018

Completed Phase 1

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor

639 Previous Clinical Trials

467,247 Total Patients Enrolled

11 Trials studying Amyotrophic Lateral Sclerosis

2,773 Patients Enrolled for Amyotrophic Lateral Sclerosis

Medical DirectorStudy DirectorBiogen

2,777 Previous Clinical Trials

8,063,669 Total Patients Enrolled

7 Trials studying Amyotrophic Lateral Sclerosis

873 Patients Enrolled for Amyotrophic Lateral Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could BIIB078 be detrimental to patients?

"Our team at Power has assigned BIIB078 a score of 1 on their safety scale due to the limited evidence for both its efficacy and security, as this is only a Phase 1 trial."

Answered by AI

Is this trial currently enrolling participants?

"The details on clinicaltrials.gov suggest that this particular medical trial is not actively recruiting patients at the moment, despite being initially posted back in April 2020 and updated shortly after February 2022. Nevertheless, 609 other trials are currently enrolling candidates."

Answered by AI

Are numerous medical centers currently administering this trial within the USA?

"This trial is presently being conducted at 16 sites around the United States, including Palo Alto, Boston and La Jolla. To reduce travel costs for participants, it is prudent to select a clinic in proximity of your location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)

2020. "Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04288856.