Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

Official Title: “A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations”

The primary objective of this study will be to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.The study duration is 4 months.

Intervention(s) in this Clinical Trial

• Drug: levodopa-carbidopa intestinal gel active and placebo capsules
  • should be kept within a range of 0.5-10 ml/hour (10-200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour);
• Drug: levodopa-carbidopa capsules active and placebo gel
  • should be kept within a range of 0.5-10 ml/hour (10-200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour);
• Device: CADD-Legacy® 1400 ambulatory infusion pump
  • pump

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • levodopa-carbidopa intestinal gel
• Active Comparator: 2
  • levodopa-carbidopa capsules

Primary Measures

• To evaluate a difference between levodopa-carbidopa intestinal gel and active control in the change from baseline and mean daily 'off' time (hours) at Week 12 (endpoint)
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To evaluate on time without troublesome dyskinesia, PDQ-39, UPDRS, caregiver burden
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria

• Idiopathic parkinson's disease(PD)according to UKPDS Brain Bank Criteria;
• levodopa-responsive and subjects demonstrate some identifiable 'on response' established by observation by investigator and demonstrate sever motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

Exclusion Criteria

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism;
• undergone surgery for the treatment of PD;
• contraindications to levodopa, subjects with any neurological deficit that may interfere with the study assessments

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Abbott Industry

Overall Clinical Trial Officials and Contacts

Janet Benesh Study Director Abbott  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660387

Study ID Number: S187.3.002

ClinicalTrials.gov Identifier: NCT00660387

Health Authority: United States: Food and Drug Administration