Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00833690 | Safety of Urate Elevation in Parkinson's Disease | PHASE2 | COMPLETED | 75 | — | — | Jun 1, 2009 | Dec 1, 2012 | Jun 5, 2014 | 16 | United States |
Defined as the extent to which assigned treatment could continue without prolonged dose reduction (\>48 consecutive days or \>73 cumulative days, which is 10% of total 2-year follow-up) due to adverse experiences (AEs), and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).
Defined as absence of serious adverse experiences (SAEs) that warranted terminating an inosine treatment arm or the trial, as determined by the Data and Safety Monitoring Committee.
| Arm | Type | Description |
|---|---|---|
| [A:] | PLACEBO_COMPARATOR | Placebo to produce no urate elevation |
| [B:] | EXPERIMENTAL | Inosine to produce a mild urate elevation 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL |
| [C.] | EXPERIMENTAL | Inosine to produce a moderate urate elevation 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 500 mg of inactive substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing adjusted algorithmically to parallel that in the inosine arms |
| inosine | DRUG | 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL |
Inclusion Criteria: * Idiopathic PD with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity) * Currently not taking or needing any treatment for PD other than an monoamine oxidase-B (MAO-B) inhibitor * Age 30 or older at the time of PD diagnosis * Diagnosis of PD made ...