Clinical Trial Alert: Biogen Seeks Participants for a Phase 3 SOD1-ALS Study
By MDA Staff | Thursday, May 30, 2019
Researchers at Biogen are looking for participants with amyotrophic lateral sclerosis (ALS) to participate in the VALOR Phase 3 study designed to help researchers evaluate the effects of BIIB067 on disease progression in patients with ALS caused by superoxide disumtase 1 (SOD1) mutation (SOD1-ALS).
In ALS, motor neurons degenerate or die and stop sending messages to the muscles, which gradually weaken and waste away. BIIB067 is an antisense oligonucleotide (ASO) that is designed to reduce levels of SOD1 protein, which may offer a therapeutic benefit.
Participants will be randomized to receive either BIIB067 (2 in 3 chance) or placebo (1 in 3 chance) to determine whether treatment with BIIB067 is associated with slowing the rate of disease progression. An open-label extension will be available, where all participants will receive BIIB067.
Study duration for each patient will be approximately 32 weeks, with about eight clinic visits (the first three doses will be given every two weeks and the five remaining doses will then be given approximately once every four weeks). The investigational drug or placebo is delivered intrathecally (through lumbar puncture). Drug efficacy will be evaluated by assessing patient function using the ALS-specific assessment scales. Throughout the study, participants will continue to see their regular doctor for routine care.
In order to be eligible to participate, adults (older than age 18) must:
- Have weakness attributable to ALS and confirmed SOD1 mutation
- If taking riluzole or edaravone, be on a stable dose and expected to remain at that dose until the final study visit
- Be medically able to undergo the study procedures and to adhere to the visit schedule at the time of study entry, as determined by the investigator
- Meet additional study criteria
Travel support is available.
To learn more or to inquire about participation, contact the US Biogen Clinical Trial Center, at (866) 633-4636 or firstname.lastname@example.org.
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