NCT03576638

Brief Summary

The purpose of this study is to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2 parkinson-disease

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2 parkinson-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 5, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 25, 2018

Last Update Submit

July 3, 2018

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Variability in plasma levodopa concentration

    as assessed by levodopa fluctuation index (comparison of AP-CD/LD to IR-CD/LD

    Pk blood sampling to be performed time 0 and every 30 minutes for 16 hours and again at 24 hours on days 1 and 8.

Secondary Outcomes (1)

  • Variability in plasma levodopa concentration

    Pk blood sampling to be performed time 0 and every 30 minutes for 16 hours and again at 24 hours on days 1 and 8.

Study Arms (2)

Sinemet

ACTIVE COMPARATOR

Controlled Release 25/100

Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet

AP CD/LD

EXPERIMENTAL
Drug: Accordion Pill Carbidopa/Levodopa

Interventions

Accordion Pill Carbidopa/LevodopaDRUG

AP 50/500 TID days 2-7

Also known as: AP-CD/LD
AP CD/LD
Sinemet CR 25Mg-100Mg Extended-Release TabletDRUG

25/100 1.5 pills five times/day

Also known as: Sinemet CR
Sinemet

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of PD consistent with UK Brain Bank Criteria
  • Stable dose of levodopa/carbidopa IR for at least 4 weeks prior to entry; taking at least 4 doses of IR levodopa during waking hours, and total daily dose of at least 400mg prior to initial screening
  • Stable on all anti-PD medications for 30 days prior to screening. COMT inhibitors are held prior to PK studies on day 1 through day 8

You may not qualify if:

  • Atypical or secondary parkinsonism
  • clinically significant cardiac, pulmonary, hepatic, or renal disease or other condition which contraindicates participation in judgement of investigator
  • severe dyskinesia as assessed by PI
  • significant cognitive impairment
  • Clinically significant psychiatric illness in opinion of PI
  • history of small bowel or gastric surgery (including PEG-J placement for Duopa/Duodopa) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn's disease, frequent nausea or emesis regardless of etiology, and symptomatic gastroparesis.
  • History of GI pathology of clinical significance as determined by PI
  • Allergy to study drug or Yellow Dye #5 (tartrazine)
  • Unable to swallow large pills
  • Active GERD and regular use of PPIs
  • Women who are pregnant or nursing or are of childbearing potential who are not willing to use a medically acceptable method of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Interventions

CarbidopaLevodopacarbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

MethyldopaDihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsHydrazinesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Central Study Contacts

Fabrizio Stocchi, MD, PhD

CONTACT

+39 0652252311fabrizio.stocchi@sanraffaele.it

Fabrizio Stocchi, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 3, 2018

Study Start

July 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

July 5, 2018

Record last verified: 2018-06