search
Back to results

A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER) (DYSCOVER)

Primary Purpose

Parkinson's Disease (PD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Optimized antiparkinsonian treatment
Levodopa-Carbidopa Intestinal Gel (LCIG)
CADD-Legacy ambulatory infusion pump
Percutaneous endoscopic gastrostomy tube
Jejunal extension tube
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease (PD) focused on measuring Carbidopa, Levodopa, Efficacy, Levodopa-carbidopa intestinal gel, Advanced Parkinson's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
  • Participants with advanced levodopa-responsive PD and persistent motor fluctuations who have not been controlled with optimized medical treatment (OMT: the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected with regard to any additional manipulations of levodopa and/or other antiparkinsonian medication based on the Investigator's clinical judgment)
  • Unified Dyskinesia Rating Scale (UDysRs) Total score ≥ 30 at Visit 3

Exclusion Criteria:

  • Participant(s) treated with levodopa-carbidopa intestinal gel (LCIG) previously
  • Participant's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g. caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g. Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD
  • Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.
  • Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma)
  • Participant(s) experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Principal Investigator

Sites / Locations

  • Parkinson's Disease Treatment Center of Southwest Florida /ID# 150095
  • Central Texas Neurology Consul /ID# 150088
  • Helsinki Univ Central Hospital /ID# 151214
  • Oulun yliopistollinen sairaala /ID# 150947
  • Mediterraneo Hospital /ID# 150955
  • University General Hospital of Heraklion "PA.G.N.I" /ID# 150956
  • University Hospital of Ioannin /ID# 150954
  • Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 170116
  • Semmelweis Egyetem /ID# 170117
  • Szegedi Tudomanyegyetem /ID# 170115
  • Policlinico Universitario Campus Bio-Medico /ID# 150846
  • A.O. Univ. Ospedali Riuniti /ID# 150853
  • Azienda USL Toscana Centro /ID# 150770
  • Seconda Universita' di Napoli /ID# 150851
  • Policlinico Tor Vergata /ID# 151167
  • Univerzitna nemocnica L. Pasteura /ID# 150146
  • Univerzitna nemocnica Martin /ID# 150145
  • Univerzitna Nemocnica Bratislava /ID# 150144
  • Univerzitna Nemocnica Bratislava /ID# 150171
  • Hospital Regional Universitari /ID# 171485
  • Hospital Universitario Cruces /ID# 203807
  • Hospital General Univ de Elche /ID# 150154
  • Hospital Univ de la Princesa /ID# 150157
  • Hospital General Universitario Gregorio Maranon /ID# 150155
  • Hospital Univ Ramon y Cajal /ID# 150152
  • Hospital Universitario Infanta /ID# 159696
  • Hospital Universitario Virgen Macarena /ID# 158861
  • Hospital Virgen de la Salud /ID# 166297

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Optimized Medical Treatment (OMT)

Levodopa-Carbidopa Intestinal Gel (LCIG)

Arm Description

Participants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT.

The total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day.

Outcomes

Primary Outcome Measures

Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score
The Unified Dyskinesia Rating Scale (UDysRS) is a tool used to assess dyskinesia in Parkinson's disease (PD) and contains both self-evaluation questions and items that are assessed directly by the physician to objectively rate the abnormal movements associated with PD. Part 1 contains 11 questions about the ON time dyskinesia and the impact of ON-dyskinesia on experiences of daily living. Part 2 contains 4 questions about OFF-dystonia rating. Part 3 contains 7 questions about objective evaluation of dyskinesia impairment and Part 4 contains 4 questions regarding dyskinesia disability. Each question is scored with respect to severity, which is rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. The UDysRS total score is obtained by summing the item scores, ranging from 0 to 104. Higher scores are associated with more disability. Negative changes from baseline indicate improvement.

Secondary Outcome Measures

Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia
The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Positive change from baseline for ON time without troublesome dyskinesia indicates improvement.
Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index
The Parkinson's Disease Questionnaire-8 (PDQ-8) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. The PDQ-8 is a self-administered questionnaire. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Higher scores are consistently associated with the more severe symptoms of the disease such as tremors and stiffness. The results are presented as a summary index. The PDQ-8 summary index ranges from 0 to 100, where lower scores indicate a better perceived health status. Negative changes from baseline indicate improvement.
Mean Clinical Global Impression of Change (CGI-C) Score at Week 12
The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.
Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living)
The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Negative values indicate improvement from baseline.
Mean Change From Baseline to Week 12 in OFF Time
The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Negative change from baseline for OFF time indicates improvement.
Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination)
The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. Higher scores are associated with more disability. Negative values indicate improvement from baseline.

Full Information

First Posted
June 10, 2016
Last Updated
August 10, 2020
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT02799381
Brief Title
A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)
Acronym
DYSCOVER
Official Title
An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study was to examine the effect of levodopa-carbidopa intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with advanced Parkinson's disease (PD).
Detailed Description
This was a Phase 3b, open-label, randomized, multicenter, 12-week study. The study consisted of 3 sequential periods: Screening, Treatment, and Follow-Up. The OMT group had the same schedule of visits/procedures throughout the study as the LCIG treatment group, except for visits related to nasojejunal (NJ)/percutaneous endoscopic gastrostomy (PEG) procedures, titration of LCIG, and follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease (PD)
Keywords
Carbidopa, Levodopa, Efficacy, Levodopa-carbidopa intestinal gel, Advanced Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimized Medical Treatment (OMT)
Arm Type
Active Comparator
Arm Description
Participants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT.
Arm Title
Levodopa-Carbidopa Intestinal Gel (LCIG)
Arm Type
Experimental
Arm Description
The total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day.
Intervention Type
Drug
Intervention Name(s)
Optimized antiparkinsonian treatment
Intervention Description
Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.
Intervention Type
Drug
Intervention Name(s)
Levodopa-Carbidopa Intestinal Gel (LCIG)
Other Intervention Name(s)
ABT-SLV187, DUOPA (carbidopa and levodopa Enteral Suspension), DUODOPA
Intervention Description
Dose levels were individually optimized.
Intervention Type
Device
Intervention Name(s)
CADD-Legacy ambulatory infusion pump
Intervention Description
(manufactured by Smiths Medical)
Intervention Type
Device
Intervention Name(s)
Percutaneous endoscopic gastrostomy tube
Intervention Description
(PEG tube)
Intervention Type
Device
Intervention Name(s)
Jejunal extension tube
Intervention Description
(J-tube)
Primary Outcome Measure Information:
Title
Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score
Description
The Unified Dyskinesia Rating Scale (UDysRS) is a tool used to assess dyskinesia in Parkinson's disease (PD) and contains both self-evaluation questions and items that are assessed directly by the physician to objectively rate the abnormal movements associated with PD. Part 1 contains 11 questions about the ON time dyskinesia and the impact of ON-dyskinesia on experiences of daily living. Part 2 contains 4 questions about OFF-dystonia rating. Part 3 contains 7 questions about objective evaluation of dyskinesia impairment and Part 4 contains 4 questions regarding dyskinesia disability. Each question is scored with respect to severity, which is rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. The UDysRS total score is obtained by summing the item scores, ranging from 0 to 104. Higher scores are associated with more disability. Negative changes from baseline indicate improvement.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia
Description
The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Positive change from baseline for ON time without troublesome dyskinesia indicates improvement.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index
Description
The Parkinson's Disease Questionnaire-8 (PDQ-8) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. The PDQ-8 is a self-administered questionnaire. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Higher scores are consistently associated with the more severe symptoms of the disease such as tremors and stiffness. The results are presented as a summary index. The PDQ-8 summary index ranges from 0 to 100, where lower scores indicate a better perceived health status. Negative changes from baseline indicate improvement.
Time Frame
Baseline, Week 12
Title
Mean Clinical Global Impression of Change (CGI-C) Score at Week 12
Description
The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Negative values indicate improvement from baseline.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline to Week 12 in OFF Time
Description
The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Negative change from baseline for OFF time indicates improvement.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. Higher scores are associated with more disability. Negative values indicate improvement from baseline.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria Participants with advanced levodopa-responsive PD and persistent motor fluctuations who have not been controlled with optimized medical treatment (OMT: the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected with regard to any additional manipulations of levodopa and/or other antiparkinsonian medication based on the Investigator's clinical judgment) Unified Dyskinesia Rating Scale (UDysRs) Total score ≥ 30 at Visit 3 Exclusion Criteria: Participant(s) treated with levodopa-carbidopa intestinal gel (LCIG) previously Participant's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g. caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g. Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease. Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma) Participant(s) experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Principal Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Parkinson's Disease Treatment Center of Southwest Florida /ID# 150095
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Central Texas Neurology Consul /ID# 150088
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Helsinki Univ Central Hospital /ID# 151214
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Oulun yliopistollinen sairaala /ID# 150947
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Mediterraneo Hospital /ID# 150955
City
Glyfada
ZIP/Postal Code
16675
Country
Greece
Facility Name
University General Hospital of Heraklion "PA.G.N.I" /ID# 150956
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
University Hospital of Ioannin /ID# 150954
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 170116
City
Pécs
State/Province
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 170117
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem /ID# 170115
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Policlinico Universitario Campus Bio-Medico /ID# 150846
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
A.O. Univ. Ospedali Riuniti /ID# 150853
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda USL Toscana Centro /ID# 150770
City
Florence
ZIP/Postal Code
50012
Country
Italy
Facility Name
Seconda Universita' di Napoli /ID# 150851
City
Naples
ZIP/Postal Code
80138
Country
Italy
Facility Name
Policlinico Tor Vergata /ID# 151167
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Univerzitna nemocnica L. Pasteura /ID# 150146
City
Košice - Západ
State/Province
Kosicky Kraj
ZIP/Postal Code
041 66
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin /ID# 150145
City
Martin
State/Province
Zilinsky Kraj
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Univerzitna Nemocnica Bratislava /ID# 150144
City
Bratislava
ZIP/Postal Code
821 01
Country
Slovakia
Facility Name
Univerzitna Nemocnica Bratislava /ID# 150171
City
Bratislava
ZIP/Postal Code
821 01
Country
Slovakia
Facility Name
Hospital Regional Universitari /ID# 171485
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Cruces /ID# 203807
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital General Univ de Elche /ID# 150154
City
Elche
ZIP/Postal Code
03202
Country
Spain
Facility Name
Hospital Univ de la Princesa /ID# 150157
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 150155
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Univ Ramon y Cajal /ID# 150152
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Infanta /ID# 159696
City
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 158861
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Virgen de la Salud /ID# 166297
City
Toledo
ZIP/Postal Code
45005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
34236101
Citation
Freire-Alvarez E, Kurca E, Lopez Manzanares L, Pekkonen E, Spanaki C, Vanni P, Liu Y, Sanchez-Solino O, Barbato LM. Levodopa-Carbidopa Intestinal Gel Reduces Dyskinesia in Parkinson's Disease in a Randomized Trial. Mov Disord. 2021 Nov;36(11):2615-2623. doi: 10.1002/mds.28703. Epub 2021 Jul 8.
Results Reference
derived
Links:
URL
http://rxabbvie.com
Description
Related Info

Learn more about this trial

A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)

We'll reach out to this number within 24 hrs