Levodopa-carbidopa Intestinal Gel Open-label Study in Advanced PD


Tracking Information

Start Date  ICMJEFebruary 2008
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 20, 2007)		Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: June 8, 2006)		(Serious) Adverse Experiences
Change HistoryComplete list of historical versions of study NCT00335153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 20, 2007)		mean daily "off" time (hours), UPDRS, CGI-I, PDQ‑39 and EQ-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: June 8, 2006)		Motor fluctuations measured with Patient Diary

Descriptive Information

Brief Title  ICMJELevodopa-carbidopa Intestinal Gel Open-label Study in Advanced PD
Official Title  ICMJEOpen-Label, 6-12 Months Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor-Fluctuations
Brief Summary

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in subjects with advanced Parkinson's Disease (PD) and severe motor-fluctuations

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEAdvanced Parkinson's Disease
Intervention  ICMJE
  • Drug: Levodopa-Carbidopa intestinal 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
Study Arms / Comparison Groups1: Experimental
Interventions:
  • Drug: Levodopa-Carbidopa intestinal gel
  • Device: CADD-Legacy® 1400

Recruitment Information

Estimated Enrollment  ICMJE250
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Idiopathic parkinson's disease(PD)according to UKPDS Brain Bank Criteria;
  • Levodopa-responsive with severe motor fluctuations;
  • Recognizable off and on state (motor fluctuations) confirmed by diary

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 (such as narrow angle glaucoma)
GenderBoth
Ages30 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Stephani Wilfordstephani.wilford@solvay.com
Location Countries  ICMJEUnited States,   Australia,   Czech Republic,   Finland,   Germany,   Italy,   Netherlands,   New Zealand,   Poland,   Portugal,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00335153
Responsible PartyStephani Wilford, Solvay Pharmaceuticals
Study ID Numbers  ICMJES187.3.004, 2006-005186-18
Study Sponsor  ICMJESolvay Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Global Clinical Director SolvaySolvay Pharmaceuticals
Information Provided BySolvay Pharmaceuticals