Long-Term Evaluation of BIIB067

Long-Term Evaluation of BIIB067

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
48
Phase:
1
Treatment Type:
Drug: BIIB067
Trial Type:
Non-Randomized, Parallel Assignment, No masking
Sponsor:
Biogen
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
Not specified
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
Not specified
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
Not specified
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
No
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

1/10/2018No significant updates
10/16/2017No significant updates
7/17/2017No significant updates
5/23/2017Contact info updated
4/18/2017Enrolling by invitation
4/18/2017Enrolling by invitation
4/18/2017Locations updated
3/6/2017Trial Added

Locations:

Orlando, 32806
Atlanta, 30322
Baltimore, 21287
Boston, 02114
St. Louis, 63110
Knoxville, 37920
Leuven, 3000
Knoxville, 37920
Toronto, M4N 3M5
Montreal, H3A2B4
Research Site, Phoenix, 85013
Research Site, San Francisco, 94115
Research Site, La Jolla, 92093-0949
Ulm, 89081
Sheffield, S102HQ

Other Information:

Purpose: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 in participants with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation (SOD1-ALS). The secondary objective is to evaluate the pharmacokinetic (PK) profile of BIIB067 in participants with SOD1-ALS.
Eligibility: 18 years +, all genders, Not accepting healthy volunteers
Details:
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 2/28/2017
ClinicalTrials.gov ID: NCT03070119
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov