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NCT03068468 · ClinicalTrials.gov registry record · Phase 2
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
A Phase 2 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 490
- Enrollment target
NCT03068468: Clinical Trial Phase 2 study, sponsored by Biogen.
NCT03068468 is a Phase 2 study that was terminated before completion, run by Biogen. The registered enrollment target is 490 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (268% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03068468, a Phase 2 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 490 participants
- Enrollment target
Study Summary
The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 \& 4 laboratory abnormalities. The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.
Primary Outcome
The PSPRS is a quantitative measure of disability in participants with PSP. The PSPRS comprises 28 items in 6 areas. Six items are rated on a 3-point scale (0-2) and 22 are rated on a 5-point scale (0-4). The 6 areas are the History/Daily Activities, Mentation, Bulbar, Ocular Motor, Limb Motor, and Gait. The 28-item PSPRS total score ranges from 0 (normal) to 100. Fifteen items are selected to form a 15-item PSPRS and three domains are identified: Gait/Limb function, Ocular Motor, and Bulbar. Th
Interventions
- DRUG Placebo
- DRUG BIIB092
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2020-02-07 |
| Phase | Phase 2 |
Why NCT03068468 stopped before completion
NCT03068468 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (268% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03068468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03068468 about?
NCT03068468 is a clinical study titled "Study of BIIB092 in Participants With Progressive Supranuclear Palsy". The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs ...
What is the current status of trial NCT03068468?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 490 participants. The study started on 2017-06-01. Estimated completion is 2020-02-07.
What interventions are being tested in trial NCT03068468?
The interventions under investigation include: Placebo (DRUG), BIIB092 (DRUG).
Who is sponsoring clinical trial NCT03068468?
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 NCT03068468's enrollment target sits among peer trials
490 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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