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A Study to Assess the Efficacy and Safety of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients (Accordance)

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ClinicalTrials.gov Identifier: NCT02605434
Recruitment Status : Recruiting
First Posted : November 16, 2015
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
Intec Pharma Ltd.

Brief Summary:
The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Accordion Pill™ Carbidopa/Levodopa Drug: Sinemet® Drug: Placebo -AP-CD/LD Drug: Placebo- Sinemet Phase 3

Detailed Description:
A multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with fluctuating PD. The study will have 2 open label Titration periods of 6 weeks each prior to the double blind Maintenance period. In the open label periods all patients will be stabilized on the active comparator Sinemet® and then on AP-CD/LD. The double blind Maintenance period will be 13 weeks long.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients
Study Start Date : March 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AP-CD/LD
Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d and Placebo IR Carbidopa/ levodopa
Drug: Accordion Pill™ Carbidopa/Levodopa
AP-CD/LD capsule containing 50 mg carbidopa with 400 mg or 500 mg levodopa administered orally twice or 3 times a day
Other Name: AP-CD/LD
Drug: Placebo -AP-CD/LD
Placebo for AP-CD/LD capsule
Active Comparator: SINEMET®
IR Carbidopa/ levodopa tablets 25/100 mg at least 4 times a day and placebo AP-CD/LD
Drug: Sinemet®
Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need
Other Name: IR Carbidopa/Levodopa
Drug: Placebo- Sinemet
Placebo for Sinemet tables

Primary Outcome Measures :
  1. Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours [ Time Frame: Baseline through study completion, an average of 27 weeks ]
    Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours based on Hauser Home Diary assessments; Total number of "Off " hours normalized to a 16- hour waking day will also be calculated but only a single p-value applicable to both the percentage and hours will be reported.

Secondary Outcome Measures :
  1. Change from Baseline through study completion, an average of 27 weeks, in "On time" without troublesome dyskinesia during waking hours [ Time Frame: Baseline through study completion, an average of 27 weeks ]
  2. Change in the number of total daily LD doses from Baseline through study completion, an average of 27 weeks (hours) [ Time Frame: Baseline through study completion, an average of 27 weeks ]
  3. CGI-I through study completion, an average of 27 weeks, as recorded by physician & patient [ Time Frame: Baseline through through study completion, an average of 27 weeks, ]
  4. Change from Baseline through study completion, an average of 27 weeks, in total UPDRS Score (Sum of Parts I-III) [ Time Frame: Baseline through study completion, an average of 27 weeks ]

Information from the National Library of Medicine

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

Main Inclusion Criteria:

  1. Men or women 30 years of age and higher, at initial screening assessment.
  2. Diagnosed with Parkinson's disease consistent with UK brain bank criteria
  3. Has a good response to levodopa and is taking at least 4 doses of IR Carbidopa/levodopa containing medication per day (or 3 doses/day of Rytary)
  4. Other Anti-PD treatment (such as dopamine agonists, selective MAO-B inhibitors, anticholinergic agents or amantadine) are permitted if stable for at least 28 days prior to study entry and provided they are not anticipated to be changed during the course of the study
  5. Total LD daily dose of 400 to 1300 mg in at least four divided doses, prior to initial screening assessment
  6. Able to complete a Hauser home diary and can tell the difference between "On and Off" time
  7. Able to adhere to the visit schedule, protocol requirements and available to complete the study
  8. At least 2.5 hours "Off time" per day during waking hours on Screening 2-Day Hauser Home Diary, (morning akinesia should be incorporated into the total "Off time" assessment)

Main Exclusion Criteria:

  1. Participation in another drug clinical trial within 28 days prior to initial screening assessment (calculated from the previous study's last dosing date)
  2. Atypical Parkinsonism (subjects with Parkinsonian features caused by disorder such as multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies or multiple brain infarcts)
  3. Clinically significant cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which contraindicates his/her participation
  4. Severe dyskinesia in the opinion of either the investigator or the Enrollment Approval Committee.
  5. Treatment with non-selective monoamine oxidase (MAO) inhibitors during the last 28 days prior to initial screening assessment or planning to take during study participation
  6. Previous or planned neurosurgical treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation) during the course of the study
  7. Significant cognitive impairment as defined by the Mini-Mental State Examination (MMSE) score < 26.
  8. Clinically significant psychiatric illness, including major depression (Hamilton Depression Rating Scale-17 ≥14). Subjects with a lifetime history of suicidal attempt (including an active attempt, interrupted attempt or aborted attempt)
  9. Current or previous treatment for more than 1 month within the past 2 years with any neuroleptic drug (antipsychotic) or any other drug with anti-dopaminergic properties (e.g. metoclopramide).
  10. Currently experiencing or any known history of psychosis or delusions within 2 years prior to Screening.
  11. Known history of substance abuse within the past 2 years
  12. Moderate or greater level of alcohol consumption
  13. Unable to swallow large pills (e.g., large vitamin pills)
  14. History of Melanoma or suspicious skin lesion which could be a Melanoma
  15. Narrow-angle Glaucoma
  16. 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, or frequent nausea or emesis, regardless of etiology which contraindicates his/her participation in the study. (Previous appendectomy or hernioplasty will not be exclusionary.
  17. Active peptic ulcer disease or a history of peptic ulcer or upper GI bleeding
  18. Regular use of opioids (Intermittent opioid use is not exclusionary)
  19. Symptomatic gastroparesis with frequent vomiting (at least once a week)
  20. Concomitant use of NSAIDs and oral steroids within the past 28 days
  21. Allergy to the study drug or any of its excipients, or to Yellow Dye #5 (tartrazine)
  22. Women who are pregnant or nursing. Women 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): NCT02605434

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Sponsors and Collaborators
Intec Pharma Ltd.
Principal Investigator: Peter A LeWitt, MD Henry Ford Hospital - West Bloomfield

Responsible Party: Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT02605434     History of Changes
Other Study ID Numbers: IN 11 004
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: December 2017

Keywords provided by Intec Pharma Ltd.:
Parkinson's Disease
Fluctuating Parkinson's Disease
Advanced Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
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