Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact

NCT00141518 | Completed Phase 4 Results

• 2 other identifiers: S187.4.0012005-002654-21
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study.

Conditions

Advanced Idiopathic Parkinson's Disease

Keywords

Health economics,Quality of life

Outcome Measures

Primary Outcomes (8)

• Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12

  The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.

  Baseline (Month -3), Month 12

• Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12

  The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).

  Baseline (Month -3), Month 12

• EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12

  The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.

  Baseline (Month -3), Month 12

• Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010

  Total monthly costs include * Direct medical costs (inpatient care, outpatient care, and drug costs \[including Duodopa cost and cost of concomitant anti-PD medication\]). * Direct non-medical costs (nursing home, home help, personal assistance, informal care \[from family member or friend\] and transportation to inpatient, outpatient visits and nursing home). * Indirect costs (sick-leave and early retirement due to PD \[applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden\]). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

  Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants

• Monthly Drug Costs Per Participant, SEK 2010

  Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

  Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants

• Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010

  Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

  Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants

• Direct Monthly Non-medical Costs Per Participant, SEK 2010

  Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

  Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants

• Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010

  Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability - is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

  Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36

Secondary Outcomes (45)

• Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36

  Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

• Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36

  Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

• Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36

  Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

• Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36

  Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

• Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36

  Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)

Other Outcomes (7)

• UPDRS Total Score up to Month 36

  Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

• UPDRS Part I Score, up to Month 36

  Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

• UPDRS Part II Score, up to Month 36

  Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Study Arms (3)

Duodopa Naïve

EXPERIMENTAL

Duodopa-naïve participants titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.

Drug: Levodopa-carbidopa intestinal gel (LCIG); Device: CADD-Legacy® 1400 ambulatory infusion pump; Device: percutaneous endoscopic gastrostomy tube (PEG tube); Device: jejunal extension tube (J-tube)

Duodopa Non-naïve < 2 Years

EXPERIMENTAL

Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.

Drug: Levodopa-carbidopa intestinal gel (LCIG); Device: CADD-Legacy® 1400 ambulatory infusion pump; Device: percutaneous endoscopic gastrostomy tube (PEG tube); Device: jejunal extension tube (J-tube)

Duodopa Non-naïve ≥ 2 years

EXPERIMENTAL

Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.

Drug: Levodopa-carbidopa intestinal gel (LCIG); Device: CADD-Legacy® 1400 ambulatory infusion pump; Device: percutaneous endoscopic gastrostomy tube (PEG tube); Device: jejunal extension tube (J-tube)

Interventions

Levodopa-carbidopa intestinal gel (LCIG) DRUG

Also known as: DUOPA™ (carbidopa and levodopa Enteral Suspension), DUODOPA®, ABT-SLV187

Duodopa Naïve; Duodopa Non-naïve < 2 Years; Duodopa Non-naïve ≥ 2 years

CADD-Legacy® 1400 ambulatory infusion pump DEVICE

Duodopa Naïve; Duodopa Non-naïve < 2 Years; Duodopa Non-naïve ≥ 2 years

percutaneous endoscopic gastrostomy tube (PEG tube) DEVICE

Duodopa Naïve; Duodopa Non-naïve < 2 Years; Duodopa Non-naïve ≥ 2 years

jejunal extension tube (J-tube) DEVICE

Duodopa Naïve; Duodopa Non-naïve < 2 Years; Duodopa Non-naïve ≥ 2 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Advanced idiopathic Parkinson's disease

You may not qualify if:

• \- Other diseases which might influence compliance or participation in the study

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Interventions

carbidopa, levodopa drug combination; Carbidopa; Jejunostomy

Intervention Hierarchy (Ancestors)

Methyldopa; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Enterostomy; Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Lars Bergmann, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: March 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 18, 2016
• Results First Posted: July 18, 2016

Record last verified: 2016-06