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NCT05216250 (BOTOX in Upper Limb Essential Tremor): BVCT ex-ante prediction vs. reported outcome

On 24 Feb 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 6 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant weak clinical benefit and commercially probably insufficient (below-MCID improvement).

Clinical Trial

NCTID
NCT05216250
Acronym
ELATE
Drug Name
BOTOX
Drug MoA
botulinum toxin type A
Drug Modality
biologic toxin
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Upper Limb Essential Tremor
Human Patients
174
Sponsor
AbbVie
Phase
Phase 2

Prediction of , index 1940

Prospective Prediction
Prediction Index
1940
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in TREDS-R/TETRAS UL inferior to propranolol)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in TREDS-R compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
224 days in advance
Readout Data Interpretation
BOTOX achieved -1 placebo-adjusted improvement in TREDS-R total unilateral score (-2.61 vs -1.61 p=0.029); which is smaller than the 0.5-SD MCID threshold (>=4.2 point for TREDS-R)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant weak clinical benefit and commercially probably insufficient (below-MCID improvement)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Upper Limb Essential Tremor
Phase
Phase 2
Status
Completed
Enrollment
174
Lead sponsor
AbbVie
Conditions
Upper Limb Essential Tremor (UL ET)
Interventions
BIOLOGICAL: BOTOX; DRUG: Placebo for BOTOX
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-04-12
Primary completion
2025-02-03
Completion
2025-02-03
Primary outcomes
  • Change From Baseline in Tremor Disability Scale-Revised (TREDS-R) Total Score Across 7 Unilateral Items (Week 24)
  • Number of Participants with Treatment Emergent Adverse Events (AEs) (Up to approximately 36 weeks)

NCT05216250 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials