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Levodopa-Carbidopa

Phase 1

Parkinson Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: Nov 21, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Levodopa-Carbidopa · 1 trial · 1 indication

Phase 1 1
NCT01484990A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's DiseaseParkinson Disease
COMPLETED19 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
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Study Endpoints

Primary Endpoints

Profile of Pharmacokinetics
5mins, then every 30 minutes up to 8 hours (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8 hour), 12, 16 (immediately after flushing the tube), 17, 18, and 19 hours.

Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.

Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam)
2 days

Evaluation of orthostatic vitals signs, ECGs, and adverse event monitoring (Screening, Day -1, Day 1, Day 2), clinical lab testing and physical exam (Screening and Day 2)

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
Levodopa-CarbidopaDRUGIntestinal Gel
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Eligibility Criteria

Age Range30 Years to 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria 1. Male or female subjects at least 30 years old; 2. Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days; 3. Body mass index range from 18.0 to 30.0 kg/m2 Exclusion Criteria 1. Subjects who are considered to be violent or subjects ...

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Frequently asked questions about Levodopa-Carbidopa

What is Levodopa-Carbidopa used for in Parkinson Disease?

Levodopa-Carbidopa is an investigational small molecule being studied for the treatment of Parkinson Disease. It is formulated as an intestinal gel and is intended for patients with advanced Parkinson's Disease. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Levodopa-Carbidopa?

Levodopa-Carbidopa is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical research on this drug for the treatment of Parkinson Disease.

What phase is Levodopa-Carbidopa in?

Levodopa-Carbidopa is in Phase 1 clinical development. It is an investigational drug and has not been approved for commercial use. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for Parkinson Disease.

What clinical trials is Levodopa-Carbidopa in?

Levodopa-Carbidopa has one completed clinical trial registered under NCT01484990, titled "A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease." This Phase 1 study enrolled 19 participants and was uncontrolled, meaning it did not use a comparison group.

Is Levodopa-Carbidopa the same as carbidopa-levodopa?

Levodopa-Carbidopa is a combination of the two active ingredients levodopa and carbidopa. The drug is being studied as an intestinal gel formulation for advanced Parkinson's Disease. It is currently in Phase 1 clinical development and is not yet approved.