Approval Probability
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Adjusted LOA
ML Risk
Infudopa i.v · 1 trial · 1 indication
To demonstrate that Infudopa i.v. and s.c. yield steady state plasma concentration of levodopa that is equivalent with that of Duodopa.
AUC of levodopa plasma concentrations during the dosage interval with Infudopa i.v. and s.c. will be compared to Duodopa.
COV for plasma levodopa concentrations during the dosage interval with Infudopa i.v. and s.c. will be compared to Duodopa.
| Arm | Type | Description |
|---|---|---|
| Infudopa i.v. | EXPERIMENTAL | Infudopa i.v. in 75% of the subject's individual pre-study dosing of Duodopa will be delivered over a 16-h period, administered as a morning rapid i.v. constant rate administration followed by continuous i.v. infusion. From patient 6 and onwards: Infudopa i.v. in 81% of the subject's individual pre-study dosing of Duodopa will be delivered over a 16-h period, administered as a morning rapid i.v. constant rate administration followed by continuous i.v. infusion. |
| Infudopa s.c. | EXPERIMENTAL | Infudopa s.c. in the same dosage as the subject's individual pre-study dosing of Duodopa will be delivered over a 16-h period, administered as a morning rapid s.c. constant rate administration followed by continuous s.c. infusion. From patient 6 and onwards: Infudopa s.c. in 86% of the subject's individual pre-study dosing of Duodopa will be delivered over a 16-h period, administered as a morning rapid s.c. constant rate administration followed by continuous s.c. infusion. |
| LCIG (Duodopa) | ACTIVE_COMPARATOR | Individually optimized dosing of LCIG (Duodopa) (delivered directly to the proximal small intestine via a percutaneous endoscopic gastrojejunostomy (PEG-J) tube connected to a portable infusion pump) will be delivered over a 16-h period, administered as a morning rapid constant rate administration followed by continuous infusion. |
| Name | Type | Description |
|---|---|---|
| Infudopa i.v. | DRUG | Infudopa i.v. infusion will be given through an indwelling catheter placed in the arm. Infudopa i.v. will be delivered in 75% of the subject's individual pre-study dosing of Duodopa. From patient 6 and onwards: Infudopa IntraV, at 81% of the subject's individual pre-study daily Duodopa dose, will be delivered over a 16-h period and administered as a continuous fixed infusion rate preceded by a morning bolus dose. The i.v. morning bolus is 110% of the hourly continuous dose delivered at the rate of 60 ml/h (mixed volume rate Infudopa Active + Infudopa Buffer IntraV). The morning dose will not exceed 24 mL, corresponding to 240 mg levodopa. The maximum daily dose levodopa during i.v. administration is not allowed to exceed 3240mg (equal to 81% of the maximum allowed daily dosage for Duodopa that is 4000 mg). |
| Infudopa s.c. | DRUG | A suitable infusion needle will be placed laterally on the abdomen for the s.c. infusion of Infudopa. Infudopa s.c. will be delivered in the same dosage as the subject's individual pre-study dosing of Duodopa, as a morning rapid s.c. constant rate administration followed by continuous s.c. infusion up to 16 h. From patient 6 and onwards: Two infusion needles will be placed on the abdomen for the s.c. infusion of Infudopa SubC in 86% of the the subject's individual pre-study daily Duodopa dose. The intervention is given as a continuous fixed infusion rate for 16h preceded by a morning bolus dose. The s.c. morning bolus is 155% of the hourly continuous dose delivered at the rate of 80 ml/h (mixed volume rate Infudopa Active + Infudopa Buffer SubC). The morning dose will not exceed 30 mL. The maximum daily dose levodopa during s.c. administration is not allowed to exceed 3440mg (equal to 86% of the maximum allowed daily dosage for Duodopa that is 4000 mg). |
| LCIG (Duodopa) | DRUG | Duodopa will be administered directly to the proximal small intestine via a PEG-J tube connected to a portable infusion pump. Individually optimized dosing of Duodopa will be administered as a morning rapid constant rate administration followed by continuous infusion and, if needed, intermittent extra doses (subject-initiated based on symptom experience). The maximum daily dose levodopa during Duodopa administration should normally not exceed 3350 mg, and is not allowed to exceed 4000 mg. From patient 6 and onwards: The pre-study daily Duodopa dose will be delivered over a 16-h period and administered as a continuous fixed infusion rate preceded by a morning bolus dose. The morning bolus is 110% of the hourly continuous dose delivered at the rate of 40 ml/h. The morning dose will not exceed 15 mL, corresponding to 300 mg levodopa. The maximum daily dose levodopa is not allowed to exceed 4000mg. |
Inclusion Criteria: 1. Signed informed consent 2. Male or female patients at least 30 years old 3. Patients with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days, on a stable treatment regimen of 685 mg to 4000 mg levodopa per day, and with approximately 16- or 2...
Infudopa i.v is an investigational small molecule being developed for the treatment of Parkinson Disease. It is currently in Phase 1 clinical development. The drug is administered intravenously and is being studied for its potential to manage symptoms of this neurological condition.
Infudopa i.v is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol DSGN. The company is conducting clinical research on this investigational drug for the treatment of Parkinson Disease.
Infudopa i.v is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for the treatment of Parkinson Disease.
Infudopa i.v has been studied in one clinical trial, identified as NCT03419806. This Phase 1 study compared intravenous and subcutaneous administration of Infudopa with intestinal Duodopa in patients with Parkinson Disease. The trial was completed and enrolled 25 participants in Sweden.
Infudopa i.v is not the same as Duodopa. While both are being studied for Parkinson Disease, Infudopa i.v is an investigational drug developed by Design Therapeutics, Inc. Duodopa is a different product used as an active comparator in the clinical trial NCT03419806, which compared the two treatments.