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Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients

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ClinicalTrials.gov Identifier: NCT03576638
Recruitment Status : Not yet recruiting
First Posted : July 3, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Intec Pharma Ltd.

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Accordion Pill Carbidopa/Levodopa Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet Phase 2

Detailed Description:
An open label, non randomized crossover phase 2 study 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. The study will have a screening period followed by an overnight stay in clinic where Immediate release CD/LD (Sinemet) will be administered five times, approximately every three hours. At specified intervals, blood will be drawn for PK testing. On Days 2-7, subjects will be treated at home with AP CD/LD three times/day, approximately every five hours. Day 8 will be overnight stay in clinic for PK study. AP CD/LD 500mg TID will be dispensed to subjects with specified timelines for PK assessment. Each subject will return to clinic on day 15 for a safety followup visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sinemet
Controlled Release 25/100
Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet
25/100 1.5 pills five times/day
Other Name: Sinemet CR

Experimental: AP CD/LD Drug: Accordion Pill Carbidopa/Levodopa
AP 50/500 TID days 2-7
Other Name: AP-CD/LD




Primary Outcome Measures :
  1. Variability in plasma levodopa concentration [ Time Frame: 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. ]
    as assessed by levodopa fluctuation index (comparison of AP-CD/LD to IR-CD/LD


Secondary Outcome Measures :
  1. Variability in plasma levodopa concentration [ Time Frame: 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. ]
    as assessed by Coefficient of variation (CV) (comparison of AP-CD/LD to IR-CD/LD)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosis of PD consistent with UK Brain Bank Criteria
  2. 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
  3. 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

Exclusion Criteria:

  1. Atypical or secondary parkinsonism
  2. clinically significant cardiac, pulmonary, hepatic, or renal disease or other condition which contraindicates participation in judgement of investigator
  3. severe dyskinesia as assessed by PI
  4. significant cognitive impairment
  5. Clinically significant psychiatric illness in opinion of PI
  6. 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.
  7. History of GI pathology of clinical significance as determined by PI
  8. Allergy to study drug or Yellow Dye #5 (tartrazine)
  9. Unable to swallow large pills
  10. Active GERD and regular use of PPIs
  11. Women who are pregnant or nursing or are of childbearing potential who are not willing to use a medically acceptable method of contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576638


Contacts
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Contact: Fabrizio Stocchi, MD, PhD +39 0652252311 fabrizio.stocchi@sanraffaele.it
Contact: Fabrizio Stocchi, MD, PhD

Sponsors and Collaborators
Intec Pharma Ltd.

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Responsible Party: Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT03576638     History of Changes
Other Study ID Numbers: IN 18001
2018-001209-95 ( EudraCT Number )
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists