Biogen 245AS102
Research type
Research Study
Full title
An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults with C9ORF72-Associated Amyotrophic Lateral Sclerosis
IRAS ID
280781
Contact name
Pamela Shaw
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2019-004798-14
Clinicaltrials.gov Identifier
2019-004798-14, EudraCT Number (field above would not accept the number)
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Summary of Research
This is an extension study to Study 245AS101. The main purpose of Study 245AS101 was to look at the safety and tolerability of BIIB078 (the study drug) when given as repeated doses in adult patients with C9ORF72-associated amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease affecting nerve cells in the brain and spinal cord. This extension study will contribute to greater understanding of the long-term effects of the study drug. The study will also look at the pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug. The study drug will be administered “intrathecally”, meaning that the study drug is given to participants by a procedure called a lumbar puncture (LP), using a thin needle that is inserted through the lower back into the fluid-filled space below the end of the spinal cord.
Participants will receive 3 doses during the loading period (3 doses of BIIB078 or 2 doses of BIIB078 and 1 dose of placebo), approximately 2 weeks apart, and 22 maintenance doses, approximately 4 weeks apart. BIIB078 will be administered at the following dose levels:
- Cohort A: 20 mg
- Cohort B: 4th dose level in 245AS101
- Cohort C: 5th dose level in 245AS101
- Possible Cohort D: Possible 6th dose level in 245AS101
The number of participants at each dose level will depend on the number of available participants who have completed dosing in Study 245AS101.
Approximately 20 sites globally are planned.Summary of Results
Suicide-related internet use of mental health patients (University of Manchester)
This study explored mental health clinicians’ experiences, beliefs and attitudes on suicide-related internet use (SRIU) disclosure and SRIU in general. This was done via online interviews. Interview questions were developed by the research team and reviewed by a consultant psychiatrist. 12 clinicians participated, half of them women, median age 36. Knowing about patient’s researching methods online was viewed as important due to the perception that it can signify increased risk as well as offer opportunity for prevention. They felt asking about SRIU to be useful as a mandatory question and age of both clinicians and patients was seen as a factor influencing inquiring on SRIU.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0159
Date of REC Opinion
20 Apr 2020
REC opinion
Favourable Opinion