Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05160558 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics and Safety Study of BIIB132 in Adults With Spinocerebellar Ataxia 3
A Phase 1 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05160558: Clinical Trial Phase 1 study, sponsored by Biogen.
NCT05160558 is a Phase 1 study that was terminated before completion, run by Biogen. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05160558, a Phase 1 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of multiple ascending doses of BIIB132 administered via intrathecal (IT) injection to participants with spinocerebellar ataxia type 3 (SCA3). The secondary objective of this study is to characterize the multiple-dose pharmacokinetics (PK) of BIIB132 administered via IT injection to participants with SCA3.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Interventions
- DRUG BIIB132
- DRUG BIIB132-Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-02-02 |
| Est. Completion | 2023-07-25 |
| Phase | Phase 1 |
Why NCT05160558 stopped before completion
NCT05160558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which BIIB132 is the first listed.
NCT05160558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05160558 about?
NCT05160558 is a clinical study titled "A Pharmacokinetics and Safety Study of BIIB132 in Adults With Spinocerebellar Ataxia 3". The primary objective of this study is to evaluate the safety and tolerability of multiple ascending doses of BIIB132 administered via intrathecal (IT) injection to participants with spinocerebellar ataxia type 3 (SCA3). The secondary objective of this study is to characterize the multiple-dose phar...
What is the current status of trial NCT05160558?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-02-02. Estimated completion is 2023-07-25.
What interventions are being tested in trial NCT05160558?
The interventions under investigation include: BIIB132 (DRUG), BIIB132-Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT05160558?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05160558's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI