Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB101 Administered to Adults With Multiple System Atrophy

• Status: Active, not recruiting
• Trial end date: 2022-07-13
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate the safety and tolerability of multiple doses of BIIB101 administered via intrathecal (IT) injection to participants with multiple system atrophy (MSA).

The secondary objective is to evaluate the pharmacokinetic (PK) profile of BIIB101.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen

Criteria

Key Inclusion Criteria:

• Screening single-photon emission computed tomography (SPECT) with DaTscan™ (ioflupane I123 injection) results demonstrating loss (whether symmetric or asymmetric) of dopamine nerve terminals in the striatum consistent with neurodegenerative parkinsonism, as assessed with qualitative, visual read.

• Diagnosed with probable or possible MSA, either parkinsonian-type (MSA-P) or cerebellar-type (MSA-C).

• Must be able to walk unassisted for at least 10 meters (approximately 30 feet)

Key Exclusion Criteria:

• Presence of cognitive dysfunction (defined as Montreal Cognitive Assessment (MoCA) score <25)

• Family history of ataxia or parkinsonism and known genetic cause of ataxia or parkinsonism.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.