Trial results for buntanetap/posiphen in early Parkinson's disease were posted on ClinicalTrials.gov on 2025-03-03. The Phase 3 study showed that 10 mg buntanetap/posiphen led to a 0.65 unit increase in MMSE scores for participants with baseline MMSE 20-28, compared to a -0.50 unit decrease for placebo in this subgroup.
Background
The study investigated buntanetap/posiphen for the treatment of early Parkinson's Disease, Idiopathic.
Trial design
The study (NCT05357989) was a Phase 3, double-blind, placebo-controlled trial that enrolled 523 participants. It investigated the efficacy and safety of buntanetap/posiphen compared with placebo in participants with early Parkinson's Disease, Idiopathic. The study duration was up to 7-8 months, with a double-blind treatment duration of up to 6 months.
Key results
Results for several key measurements were posted. All values represent the least squares mean change from baseline to Month 6, with standard error (SE) provided.
- Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state):
- Placebo: -0.10 units (SE: 0.311)
- 10 mg Buntanetap/Posiphen: 0.57 units (SE: 0.312)
- 20 mg Buntanetap/Posiphen: -0.04 units (SE: 0.319)
- Change From Baseline to Month 6 in the MDS-UPDRS Part III (OFF-state):
- Placebo: -2.90 units (SE: 0.698)
- 10 mg Buntanetap/Posiphen: -1.04 units (SE: 0.697)
- 20 mg Buntanetap/Posiphen: -2.66 units (SE: 0.713)
- Change From Baseline to Month 6 in MMSE (OFF-state):
- Placebo: -0.39 units (SE: 0.123)
- 10 mg Buntanetap/Posiphen: -0.08 units (SE: 0.123)
- 20 mg Buntanetap/Posiphen: -0.05 units (SE: 0.126)
- Change From Baseline to Month 6 in MMSE (OFF-state) for Participants With Baseline MMSE Scores 20-28:
- Placebo: -0.50 units (SE: 0.317)
- 10 mg Buntanetap/Posiphen: 0.65 units (SE: 0.313)
- 20 mg Buntanetap/Posiphen: 0.45 units (SE: 0.301)
What this means
The trial results indicate that buntanetap/posiphen did not show a clear benefit over placebo in the overall population for MDS-UPDRS Part II and Part III scores, where lower scores indicate improvement. However, for the Mini-Mental State Examination (MMSE) scores, both 10 mg and 20 mg buntanetap/posiphen showed a smaller decline compared to placebo in the overall population. More notably, in the subgroup of participants with baseline MMSE scores between 20 and 28, both doses of buntanetap/posiphen demonstrated an increase in MMSE scores (0.65 units for 10 mg and 0.45 units for 20 mg), while the placebo group experienced a decrease (-0.50 units). This suggests a potential cognitive benefit for buntanetap/posiphen in a specific subgroup of early Parkinson's disease patients with lower baseline cognitive function.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05357989, titled "A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD," were posted on 2025-03-03 on clinicaltrials.gov.