Clinical trial NCT01515410: Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations
Official title: A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Motor Fluctuations
Keywords: Parkinson's disease
PD
stage2/3Parkinson's
Advanced Parkinson's Disease with Motor Fluctuations
Lead sponsor: Depomed
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by:

* "ON" time with no dyskinesia or non-troublesome dyskinesia
* "OFF" time


Eligibility criteria: Inclusion Criteria:

1. Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
2. Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
3. On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
4. Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
5. Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
6. Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
7. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
8. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.

Exclusion Criteria:

1. Patients with atypical or drug-induced Parkinson's disease.
2. Patients with a known history of hypersensitivity to levodopa or carbidopa.
3. Patients who receive treatments with dopamine receptor blocking agents
4. Patients with a history of seizures except of childhood febrile seizure.
5. Patients with dementia.
6. Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.
7. Patients with any history of gastric surgery other than vagotomy and pyloroplasty.
8. Patients with an immune-compromised state.
9. Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.
10. Patients with a calculated creatinine clearance (Clcr) \< 50 mL/min using the Cockcroft-Gault equation.
11. Patients who have a difficulty swallowing tablets.
12. Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
13. Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.

Primary outcomes:
measure: The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.
timeFrame: Baseline and 10 days for each of the 2 study periods
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Long Beach
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Bingham Farms
country: United States
state: Michigan
city: Cincinnati
country: United States
state: Ohio
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Depomed
name: Rekha Sathyanarayana
role: STUDY_DIRECTOR
References: