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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07280299 | Efficacy, Safety, Tolerability, and Biomarker Effects of GT-02287 in Early Parkinson's Disease | PHASE2 | NOT YET_RECRUITING | 111 | — | — | May 30, 2026 | Jun 30, 2028 | Dec 12, 2025 | - | — |
| NCT06732180 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GT-02287 in Parkinson's Disease | PHASE1 | RECRUITING | 20 | — | — | Feb 21, 2025 | Nov 30, 2025 | May 6, 2025 | 7 | Australia |
Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score assessed in the practically defined OFF state. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of four parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be rated by the patient and/or caregiver. Part III assesses the motor signs of PD and is rated by the investigator (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD.
| Arm | Type | Description |
|---|---|---|
| Low Dose GT-02287 | ACTIVE_COMPARATOR | GT-02287 400 or 600 mg/day |
| High Dose GT-02287 | ACTIVE_COMPARATOR | GT-02287 800 or 1000 mg/day |
| Placebo | PLACEBO_COMPARATOR | Magnesium aluminometasilicate (MAS) |
| single-arm. All participants receive the active molecule (once daily GT-02287 administration) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Low Dose GT-02287 | DRUG | Sachets containing 400 mg/day or 600 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water. |
| High Dose GT-02287 | DRUG | Sachets containing 800 mg/day or 1000 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water. |
| Placebo | DRUG | Sachets containing 420 to 1200 mg of MAS indistinguishable from the active sachets. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water. |
| GT-02287 | DRUG | Dose of 13.5 mg/kg/day (plus/minus 2 mg/kg/day based on body weight) to be administered orally once a day for 90 days. Dosage form: powder in sachet (200 mg of GT-02287 per sachet) for reconstitution with a suspending agent |
Inclusion Criteria: * Able and willing to provide written informed consent and willing to comply with the requirements and restrictions of the study * Willing to undergo PD-related genetic testing and analysis * Any sex, ≥30 and ≤85 years of age * Body mass index of ≥18 and ≤40 kg/m2 and a body wei...