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NCT05418673 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 7
- Enrollment target
NCT05418673: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT05418673 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 7 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05418673, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 7 participants
- Enrollment target
Study Summary
In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic variant in their LRRK2 gene. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of PD more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. * The MDS-UPDRS measures impairment and disability in people living with PD. It was created in the 1980s and is one of the most used rating scales for PD symptoms. * The MDS-UPDRS has 4 parts, and a higher score means more severe PD symptoms. * Part I assesses non-motor experiences of daily living, including but not limited to memory loss, problems sleeping, pain, depression, and anxiety. * Part II measures motor experiences of daily living. * Part III is the results of a motor symptoms exam by a medical professional. * Part IV records PD complications caused by motor symptoms. Researchers will also learn more about the safety of BIIB122. A description of how the study will be done is given below. * Participants will take BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but contains no real medicine. * Participants will be in the study for 103 weeks to 187 weeks. This includes the screening and follow-up periods. * Participants will take BIIB122 or placebo 1 time a day for 96 to 180 weeks. * Participants can continue to take certain medications for PD. Participants must be on the same dose of medication for at least 90 days before the study begins. * Participants will visit the clinic less often as the study continues, ranging every 4 weeks to every 24 weeks.
Primary Outcome
Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (range 0-52). It contains 13 questions which are to be completed by the participant. Part III assesses the motor signs of PD and is administered by the rater (range 0-132). Part III contains 33 scores based on 18 items. For each question, a numeric score i
Interventions
- DRUG BIIB122
- DRUG BIIB122-Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-08-26 |
| Est. Completion | 2023-07-27 |
| Phase | Phase 3 |
Why NCT05418673 stopped before completion
NCT05418673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which BIIB122 is the first listed.
NCT05418673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05418673 about?
NCT05418673 is a clinical study titled "A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale". In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic variant in their LRRK2 gene. The main question researchers are trying to answer is if taking BIIB122 s...
What is the current status of trial NCT05418673?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 7 participants. The study started on 2022-08-26. Estimated completion is 2023-07-27.
What interventions are being tested in trial NCT05418673?
The interventions under investigation include: BIIB122 (DRUG), BIIB122-Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT05418673?
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 NCT05418673's enrollment target sits among peer trials
7 1995th of 2000 higher than 6 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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