parallel randomized trial
Exenatide-PD3
A Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide extended release 2 mg subcutaneous once weekly Exenatide extended release 2 mg weekly | stable dopaminergic therapy; lifestyle: not reported | 97 | 92 | |
| A2 | Placebo Placebo | stable dopaminergic therapy; lifestyle: not reported | 97 | 96 |
Analyses this trial contributes to
Results
9 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Motor function (Parkinson disease) (4 lines; O101)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 96 | A1 vs A2 | md | 6.06 points | 4.03 to 8.10 | not stated; other; age:60_or_less; R0021160:Table 3 | ||
| 96 | A1 vs A2 | md | 3.25 points | 1.84 to 4.65 | not stated; other; age:more_than_60; R0021160:Table 3 | ||
| 96 | A1 vs A2 | md | 3.01 points | 2.02 to 4.00 | not stated; other; sex:female; R0021160:Table 3 | ||
| 96 | A1 vs A2 | md | 4.51 points | 3.68 to 5.34 | not stated; other; sex:male; R0021160:Table 3 |
Discontinuation due to adverse events (5 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 97 | not stated; randomized; R0021160:Figure 1 | ||||
| A1 | events | 8 / 92 | not stated; modified itt; R0021160:Figure 1 | ||||
| A1 | events | 1 / 92 | not stated; modified itt; R0021160:Figure 1 | ||||
| A2 | events | 1 / 96 | not stated; modified itt; R0021160:Figure 1 | ||||
| A2 | events | 1 / 96 | not stated; modified itt; R0021160:Figure 1 |