A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations.

Phase 1

Conditions: Parkinson's disease patients who suffer motor fluctuations willparticipate in the study
MedDRA version: 17.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-002295-87-IT

Lead Sponsor: SynAgile Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 18

Inclusion Criteria

1. PD diagnosis consistent with UK 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. 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 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.