Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa (LD/CD) vs.semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson's disease (PD) who suffer motor fluctuations.The objective of this study is to assess the plasma pharmacokinetics (PK) of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD. For purposes of this study continuous intra-oral administration of LD/CD is defined as oral administration of LD/CD at 5-10 minute intervals.

Secondary objectives are to assess the safety and tolerability of continuous intra-oral administration of LD/CD and the effect on PD motor function of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Collaborator: SynAgile Corporation
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

Inclusion criteria

1. PD diagnosis consistent with United Kingdom Brain Bank Criteria

2. Good response to levodopa with at least 2 hours of wearing off episodes in judgment of investigator

3. Stable doses of levodopa plus/minus other dopaminergic therapy (minimum of 4 weeks for each drug)

4. Mini Mental Score Examination (MMSE): score > 26

5. Capable of providing informed consent

6. No clinically significant medical, psychiatric or laboratory abnormalities in the judgment of the investigator.

7. No history of psychosis or hallucinations in the past 6 months

8. Women who are capable of child bearing must have a negative urine pregnancy test at screening visit and use an adequate contraceptive method throughout the study.

9. Approval for entry into the study by an enrolment steering committee

Exclusion criteria

1. Atypical or secondary parkinsonism

2. Severe dyskinesia that might interfere with study performance in judgment of investigator

3. Patient receiving duodopa, apomorphine infusion or Deep Brain Stimulation (DBS)

4. Dysphagia or sialorrhea that might interfere with administration of study intervention

5. Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, would interfere with performing a pharmacokinetic study or would interfere with drug absorption.