Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Suvecaltamide · 1 trial · 2 indications
The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6a, 6b, and 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6a, 6b, and 7 of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe tremor. The change from baseline is being reported where the greater the change from baseline indicates improvement in outcome.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants who will receive a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period. |
| Sulvecaltamide | EXPERIMENTAL | Participants who will receive an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Matching placebo capsule(s) administered every day (QD) orally. Titration may proceed at a rate of 1 matching placebo capsule per day every 7 days as required for optimal efficacy and tolerability up to a maximum number of 3 matching placebo capsules per day. |
| Suvecaltamide | DRUG | Suvecaltamide capsule administered every day (QD) orally. Titration may proceed at a rate of 10 mg suvecaltamide per day every 7 days as required for optimal efficacy and tolerability up to a maximum dose of 30 mg suvecaltamide per day. |
KEY Inclusion Criteria: * Diagnosis of clinically probable or clinically established Parkinson's disease (PD) meeting the Movement Disorder Society (MDS) 2015 criteria. * Participants must be individually optimized on PD medications for the treatment of other cardinal signs of PD (bradykinesia, rig...
Suvecaltamide is an investigational small molecule being studied for the treatment of moderate to severe residual tremor in adults with Parkinson Disease. It is a Phase 2 candidate developed by Jazz Pharmaceuticals plc. The drug is not approved and remains in clinical development.
The specific molecular target of Suvecaltamide has not been disclosed in available information. It is a small molecule being evaluated for its effect on tremor in Parkinson Disease, but its mechanism of action is not publicly detailed.
Suvecaltamide is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on NASDAQ under the ticker JAZZ. The company is conducting clinical research on this drug for Parkinson Disease tremor.
Suvecaltamide is in Phase 2 clinical development. A Phase 2 study has been completed, and the drug is not yet approved by regulatory authorities. It remains investigational for the treatment of tremor in Parkinson Disease.
Suvecaltamide has one completed Phase 2 trial, NCT05642442, which studied the drug in adults with moderate to severe residual tremor in Parkinson Disease. The randomized, double-blind, placebo-controlled trial enrolled 169 participants across the United States, Germany, Poland, and Spain.
No alternative names for Suvecaltamide have been identified. It is referred to solely by its generic name, Suvecaltamide, in clinical trial records and development documentation.