Parkinson's Disease
Conditions
Keywords
Parkinson's disease, time to on, delayed on
Brief summary
To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
Detailed description
This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.
Interventions
DRUGParcopa
at subjects current stable dose of comparator
DRUGcarbidopa-levodopa (Sinemet)
at subjects current stable dose
Sponsors
UCB Pharma
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
31 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's disease for at least three years duration * Patients requiring levodopa for their PD * Good subjective response to levodopa * Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures * A UPDRS -off- motor score of at least 25 * Subjects willing to give informed consent * Subjects who are able and willing to comply with study procedures * If female of child-bearing potential, will use one of the approved birth control measures: 1. Hormonal contraceptives 2. Spermicidal and barrier 3. Intrauterine device 4. Partner sterility
Exclusion criteria
* Subjects with evidence of significant dementia * Subjects with significant oral lesions * History of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry * History of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions * History of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry. * Subjects with poor response to levodopa * Women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Time in Minutes From When a Patient Was in a Clinical Off State, Took Their Medication and Went Into a Clinical on State | first dose of day for each arm | Time to on state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days. |
Countries
United States
Participant flow
Recruitment details
Crossover study design
Participants by arm
| Arm | Count |
|---|---|
| B-Parcopa Arm First Then Crossover to Carbidopa/Levodopa Arm Parcopa: at subjects current stable dose of comparator | 10 |
| A-Carbidopa/Levodopa Arm Then Crossover to Parcopa Arm carbidopa-levodopa at subjects current stable dose | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | swallowed oral dissolving dose | 1 | 0 |
Baseline characteristics
| Characteristic | Total | B-Parcopa Arm First Then Crossover to Carbidopa/Levodopa Arm | A-Carbidopa/Levodopa Arm Then Crossover to Parcopa Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 7 Participants | 6 Participants |
| Race/Ethnicity, Customized African-American | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 15 participants | 7 participants | 8 participants |
| Race/Ethnicity, Customized Hispanic | 3 participants | 2 participants | 1 participants |
| Region of Enrollment United States | 20 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 14 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Measurement of Time in Minutes From When a Patient Was in a Clinical Off State, Took Their Medication and Went Into a Clinical on State
Time to on state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days.
Time frame: first dose of day for each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B-Parcopa Arm | Measurement of Time in Minutes From When a Patient Was in a Clinical Off State, Took Their Medication and Went Into a Clinical on State | 23.9 minutes | Standard Deviation 9.9 |
| A-Carbidopa/Levodopa Arm | Measurement of Time in Minutes From When a Patient Was in a Clinical Off State, Took Their Medication and Went Into a Clinical on State | 28.5 minutes | Standard Deviation 19.4 |