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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001329-33 | EudraCT Number |
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| Name | Class |
|---|---|
| IQVIA, formerly Quintiles | UNKNOWN |
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The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study S187.3.004 [NCT00335153]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodopa-Carbidopa Intestinal Gel | Experimental | Initial dosing is based on the dosing regimen that the participant received during the previous LCIG study. Dosing is individually optimized and can be adjusted at any time during the study as clinically indicated. The total dose/day of LCIG is composed of 3 individually adjusted doses. The morning dose is administered as a bolus infusion, usually 5 to 10 mL (100 to 200 mg levodopa). The maintenance dose is adjustable in steps of 2 mg/hour (0.1 mL/hour), within a range of 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). Participants will be allowed to self-administer extra doses of LCIG to address immediate medical needs, normally 0.5 to 2.0 mL. Participants will receive LCIG until it is commercially available. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa-Carbidopa Intestinal Gel (LCIG) | Drug | LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure. At least possibly drug-related is defined as TEAEs assessed as having a "Possible" or "Probable" or missing relationship to study drug. Serious AEs included any untoward medical occurrence that:
The severity of all AEs was characterized as mild, moderate or severe according to the following definitions:
| From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device Complications | Device complications include complications with the pump, intestinal tube, PEG-J or stoma. | From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days. |
| Number of Participants With Sleep Attacks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham /ID# 49941 | Birmingham | Alabama | 35294 | United States | ||
| The Research Center of Southern California /ID# 49928 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29570853 | Result | Fernandez HH, Boyd JT, Fung VSC, Lew MF, Rodriguez RL, Slevin JT, Standaert DG, Zadikoff C, Vanagunas AD, Chatamra K, Eaton S, Facheris MF, Hall C, Robieson WZ, Benesh J, Espay AJ. Long-term safety and efficacy of levodopa-carbidopa intestinal gel in advanced Parkinson's disease. Mov Disord. 2018 Jul;33(6):928-936. doi: 10.1002/mds.27338. Epub 2018 Mar 23. |
| Label | URL |
|---|---|
| Related Info | View source |
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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, analyses plans, 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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
This study was an open-label extension study for participants with Parkinson's disease (PD) who had completed one of the prior studies S187.3.003 (NCT00360568) or S187.3.004 (NCT00335153). Participants were to receive continued access to levodopa-carbidopa intestinal gel (LCIG) in the extension study until treatment became commercially available in their home country.
Enrollment began in November 2009 and was completed in October 2012. Participants were enrolled at 61 sites in 11 countries: Australia, Canada, Czech Republic, Israel, New Zealand, Poland, Portugal, the Russian Federation, Thailand, the United Kingdom, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levodopa-Carbidopa Intestinal Gel | Participants received levodopa-carbidopa intestinal gel (LCIG), continuously administered through a percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2013 | Oct 20, 2022 |
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| CADD-Legacy® 1400 ambulatory infusion pump | Device | Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir. |
|
| Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J) | Device | All participants previously had a PEG-J placed in one of the prior LCIG studies. |
|
Participants were asked whether they experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. If yes, participants were asked if they suffered any "bad" outcome or problem from the falling asleep event. |
| Baseline (final assessment period of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days. |
| Number of Participants With Intense Impulsive Behavior | To monitor for the development of intense impulsive behavior the Minnesota Impulsive Disorder Interview (MIDI) was administered. The MIDI is a semi-structured clinical interview assessing pathological gambling, trichotillomania, kleptomania, pyromania, intermittent explosive disorder, compulsive buying, and compulsive sexual behavior. | Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days. |
| Number of Participants Who Developed Melanoma | A comprehensive assessment for the presence of melanoma was performed at least once a year by a dermatologist. | Once per year during the study; median duration of treatment was 1178 days. |
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI) | Adverse events of special interest (AESIs) were identified using standardized Medical Dictionary for Regulatory Activities (MedDRA) queries (SMQ) or company MedDRA queries (CMQs). The AESI in the following categories were identified on the basis of review of the clinical program and postmarketing observations where the treatment system is commercially available.
| From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years). |
| Number of Participants With Any Suicidal Ideation or Behavior | The Columbia-Suicide Severity Rating Scale (C-SSRS) was implemented with Protocol Amendment 3 (20 March 2012) in order to assess suicidal behavior and ideation. Suicidal ideation includes the wish to be dead, nonspecific active suicidal thoughts, active ideation without intent to act, active ideation with some intent to act, and active ideation with specific plan or intent. Suicidal behavior includes actual attempts, interrupted attempts, aborted attempts, completed suicide, and preparatory acts or behaviors. The number of participants with affirmative responses on the C-SSRS at any time during the treatment period is reported. | Every 6 months (beginning with implementation of Protocol Amendment 3) until final visit; median duration of treatment was 1178 days. |
| Number of Participants With Potentially Clinically Significant Vital Sign Values | A vital sign value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding Baseline value. | Baseline and every 6 months until final visit; median duration of treatment was 1178 days. |
| Number of Participants With Potentially Clinically Significant Hematology Laboratory Values | A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding Baseline value. | Baseline and every 6 months until final visit; median duration of treatment was 1178 days. |
| Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values | A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding baseline value. ULN = upper limit of normal | Baseline and every 6 months until final visit; median duration of treatment was 1178 days. |
| Number of Participants With Vitamin Levels Outside of the Normal Range | Special tests for vitamin deficiencies (folic acid, vitamin B6, vitamin B12, methylmalonic acid [MMA], and homocysteine) were implemented with Protocol Amendment 2 (27 July 2011). The number of participants with vitamin levels outside of the normal range at any time post-baseline is reported for each vitamin tested. | Every 6 months (beginning with implementation of Protocol Amendment 2) until final visit; median duration of treatment was 1178 days. |
| Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year | Participants could use oral levodopa-carbidopa for scheduled or supplemental bedtime/overnight doses after the pump was disconnected for the night, or as rescue medication in case of acute deterioration caused by failure of the LCIG system such as tubes and/or the pump or the onset of an acute illness. The initiation of additional concomitant PD medication was allowed at the discretion of the Investigator if medically indicated. | Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10, > Year 10 (maximum time on treatment was approximately 11.5 years). |
| Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment | The PD symptom diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "Off" time was defined as time when medication had worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A negative change for "off" time indicates improvement. The PD diary assessment was implemented with Protocol amendment 4 (December 2013) for participants at United States (US) sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment | The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Non-troublesome dyskinesia does not interfere with function or cause meaningful discomfort. "On" time without troublesome dyskinesia is the sum of "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment | The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Troublesome dyskinesia interferes with function or causes meaningful discomfort. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). UPDRS Part III consists of 14 questions. Questions 20 - 26 are multi-part questions in that they are evaluated separately for multiple body parts. Counting each of these assessments leads to a total of 27 answers for Part III. The UPDRS Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-Point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The UPDRS total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I - III of the scale. The total score ranges from 0 - 176 with 176 representing the worst (total) disability, and 0 no disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias). The UPDRS Part IV Score is the sum of all answers to the 11 questions that comprise Part IV, 4 of which are measured on a 5-point scale (0 - 4) and 7 which are measured on a 2-point scale (0 - 1). The Part IV score ranges from 0 - 23 with higher scores associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias); and The UPDRS Part IV dyskinesia Score is the sum of Questions 32 (What proportion of the waking day are dyskinesias present?), 33 (How disabling are the dyskinesias? ), and 34 (How painful are the dyskinesias?) on UPDRS Part IV, each of which are measured on a 5-point scale (0-4). The Part IV dyskinesia score ranges from 0 - 12 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment | The PDQ-39 is a self-administered questionnaire that comprises 39 items addressing the following eight domains of health that patients consider to be adversely affected by the disease:
Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness. The PDQ-39 summary index (range 0-100) includes responses to all 39 items. A negative change indicates improvement. | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
| Encinitas |
| California |
| 92024 |
| United States |
| The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915 | Fountain Valley | California | 92708 | United States |
| Universtiy of Southern California /ID# 49913 | Los Angeles | California | 90033 | United States |
| Colorado Neurological Institute /ID# 49927 | Englewood | Colorado | 80113 | United States |
| Georgetown University Hospital /ID# 49931 | Washington D.C. | District of Columbia | 20007 | United States |
| Bradenton Research Center, Inc /ID# 49929 | Bradenton | Florida | 34205 | United States |
| Neurologic Consultants, PA /ID# 49918 | Fort Lauderdale | Florida | 33308 | United States |
| University of Florida - Archer /ID# 49935 | Gainesville | Florida | 32610 | United States |
| University of Florida /ID# 49922 | Jacksonville | Florida | 32209 | United States |
| Charlotte Neurological Service /ID# 49916 | Port Charlotte | Florida | 33980 | United States |
| University of South Florida /ID# 49919 | Tampa | Florida | 33612 | United States |
| Georgia Regents University /ID# 49938 | Augusta | Georgia | 30912 | United States |
| Northwestern University Feinberg School of Medicine /ID# 49944 | Chicago | Illinois | 60611-2927 | United States |
| Rush University Medical Center /ID# 49930 | Chicago | Illinois | 60612 | United States |
| University of Kentucky Chandler Medical Center /ID# 49940 | Lexington | Kentucky | 40536 | United States |
| Louisiana State Univ HSC /ID# 49945 | Shreveport | Louisiana | 71130 | United States |
| Univ Maryland School Medicine /ID# 49934 | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University /ID# 49937 | Baltimore | Maryland | 21287 | United States |
| Washington University-School of Medicine /ID# 49933 | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center /ID# 49911 | Omaha | Nebraska | 68198 | United States |
| North Shore University Hospital /ID# 49932 | Manhasset | New York | 11030 | United States |
| The Mount Sinai Hospital /ID# 49942 | New York | New York | 10029 | United States |
| Columbia Univ Medical Center /ID# 49943 | New York | New York | 10032-3725 | United States |
| Raleigh Neurology Associates /ID# 49923 | Raleigh | North Carolina | 27607 | United States |
| Wake Forest Univ HS /ID# 49939 | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati /ID# 49914 | Cincinnati | Ohio | 45267-0585 | United States |
| Cleveland Clinic Main Campus /ID# 76173 | Cleveland | Ohio | 44195 | United States |
| University of Vermont Medical Center /ID# 49912 | Burlington | Vermont | 05401-1473 | United States |
| King County Public Hospital /ID# 49917 | Kirkland | Washington | 98034 | United States |
| Froedtert Memorial Lutheran Hospital /ID# 49924 | Milwaukee | Wisconsin | 53226 | United States |
| Westmead Hospital /ID# 50081 | Westmead | New South Wales | 2145 | Australia |
| Royal Adelaide Hospital /ID# 50083 | Adelaide | South Australia | 5000 | Australia |
| Austin Hospital /ID# 50082 | Heidelberg | Victoria | 3084 | Australia |
| University of Alberta /ID# 78476 | Edmonton | Alberta | T6G 2B7 | Canada |
| Toronto Western Hospital /ID# 75913 | Toronto | Ontario | M5T 2S8 | Canada |
| CHUM - Notre-Dame Hospital /ID# 74513 | Montreal | Quebec | H2X 0A9 | Canada |
| Fakultni Nemocnice u Svate Anny /ID# 50085 | Brno | 656 91 | Czechia |
| Fakultni nemocnice Hradec Kralove /ID# 50088 | Hradec Králové | 500 05 | Czechia |
| Pardubicka krajska nemocnice, a.s. | Pardubice | 532 03 | Czechia |
| Vseobecna fakultni nemocnice v Praze /ID# 50086 | Prague | 128 21 | Czechia |
| Fakultni Nemocnice v Motole /ID# 50084 | Prague | 150 06 | Czechia |
| Tel Aviv Sourasky Medical Center /ID# 50089 | Tel Aviv | 64239 | Israel |
| Waikato Hospital /ID# 50091 | Hamilton | Waikato Region | 3240 | New Zealand |
| Auckland City Hospital /ID# 50093 | Auckland | 1023 | New Zealand |
| New Zealand Brain Research Institute/ID# 50090 | Christchurch | 8011 | New Zealand |
| Wellington Hospital /ID# 50092 | Wellington | 6021 | New Zealand |
| NZOZ Centrum Medyczne HCP /ID# 50094 | Poznan | Greater Poland Voivodeship | 61-485 | Poland |
| Miejskie Centrum Medyczne im. dr. Karola Jonschera w Lodzi /ID# 50096 | Lodz | Łódź Voivodeship | 93-113 | Poland |
| Hospitais da Universidade de Coimbra /ID# 50098 | Coimbra | 3000-075 | Portugal |
| Hospital de Santa Maria /ID# 50099 | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar Universitario de Sao Joao, EPE /ID# 50101 | Porto | 4200-319 | Portugal |
| Scientific Research Medical Complex Your Health /ID# 50104 | Kazan' | 420097 | Russia |
| Institution of the Russian Academy of Medical Sciences Scientific Centre of Neurology /ID# 50102 | Moscow | 125367 | Russia |
| Military Medical Academy n.a. Kirov /ID# 50103 | Saint Petersburg | 194044 | Russia |
| I.P. Pavlov First St. Petersburg State Medical University /ID# 50107 | Saint Petersburg | 197022 | Russia |
| City Clinical Hospital #40 /ID# 50106 | Saint Petersburg | 197706 | Russia |
| King Chulalongkorn Mem Hosp /ID# 50108 | Bangkok | 10330 | Thailand |
| Siriraj Hospital /ID# 50109 | Bangkok | 10700 | Thailand |
| The Walton Centre NHS Foundation /ID# 50003 | Liverpool | L9 7LJ | United Kingdom |
| National Hospital for Neurology & Neurosurgery | London | WC1N 3BG | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Levodopa-Carbidopa Intestinal Gel | Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment-emergent Adverse Events | Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure. At least possibly drug-related is defined as TEAEs assessed as having a "Possible" or "Probable" or missing relationship to study drug. Serious AEs included any untoward medical occurrence that:
The severity of all AEs was characterized as mild, moderate or severe according to the following definitions:
| All participants who received LCIG in this extension study | Posted | Count of Participants | Participants | From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years). |
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| Secondary | Number of Participants With Device Complications | Device complications include complications with the pump, intestinal tube, PEG-J or stoma. | All participants who received LCIG in this extension study | Posted | Count of Participants | Participants | From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants With Sleep Attacks | Participants were asked whether they experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. If yes, participants were asked if they suffered any "bad" outcome or problem from the falling asleep event. | All participants who received LCIG in this extension study with available sleep attack data. The number of participants who experienced a sleep attack with a bad outcome or problem is based on the number of participants who reported sleep attacks. | Posted | Count of Participants | Participants | Baseline (final assessment period of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants With Intense Impulsive Behavior | To monitor for the development of intense impulsive behavior the Minnesota Impulsive Disorder Interview (MIDI) was administered. The MIDI is a semi-structured clinical interview assessing pathological gambling, trichotillomania, kleptomania, pyromania, intermittent explosive disorder, compulsive buying, and compulsive sexual behavior. | All participants who received LCIG in this extension study with available MIDI data. | Posted | Count of Participants | Participants | Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants Who Developed Melanoma | A comprehensive assessment for the presence of melanoma was performed at least once a year by a dermatologist. | All participants who received LCIG in this extension study | Posted | Count of Participants | Participants | Once per year during the study; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI) | Adverse events of special interest (AESIs) were identified using standardized Medical Dictionary for Regulatory Activities (MedDRA) queries (SMQ) or company MedDRA queries (CMQs). The AESI in the following categories were identified on the basis of review of the clinical program and postmarketing observations where the treatment system is commercially available.
| ll participants who received LCIG in this extension study | Posted | Count of Participants | Participants | From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years). |
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| Secondary | Number of Participants With Any Suicidal Ideation or Behavior | The Columbia-Suicide Severity Rating Scale (C-SSRS) was implemented with Protocol Amendment 3 (20 March 2012) in order to assess suicidal behavior and ideation. Suicidal ideation includes the wish to be dead, nonspecific active suicidal thoughts, active ideation without intent to act, active ideation with some intent to act, and active ideation with specific plan or intent. Suicidal behavior includes actual attempts, interrupted attempts, aborted attempts, completed suicide, and preparatory acts or behaviors. The number of participants with affirmative responses on the C-SSRS at any time during the treatment period is reported. | All participants who received LCIG in this extension study with available C-SSRS data. | Posted | Count of Participants | Participants | Every 6 months (beginning with implementation of Protocol Amendment 3) until final visit; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants With Potentially Clinically Significant Vital Sign Values | A vital sign value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding Baseline value. | All participants who received LCIG in this extension study with at least one post-baseline measurement for each parameter. | Posted | Count of Participants | Participants | Baseline and every 6 months until final visit; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants With Potentially Clinically Significant Hematology Laboratory Values | A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding Baseline value. | All participants who received LCIG in this extension study with at least one post-baseline measurement for each parameter. | Posted | Count of Participants | Participants | Baseline and every 6 months until final visit; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values | A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding baseline value. ULN = upper limit of normal | All participants who received LCIG in this extension study with at least one post-baseline measurement for each parameter | Posted | Count of Participants | Participants | Baseline and every 6 months until final visit; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants With Vitamin Levels Outside of the Normal Range | Special tests for vitamin deficiencies (folic acid, vitamin B6, vitamin B12, methylmalonic acid [MMA], and homocysteine) were implemented with Protocol Amendment 2 (27 July 2011). The number of participants with vitamin levels outside of the normal range at any time post-baseline is reported for each vitamin tested. | All participants who received LCIG in this extension study with at least one post-baseline measurement for each parameter. | Posted | Count of Participants | Participants | Every 6 months (beginning with implementation of Protocol Amendment 2) until final visit; median duration of treatment was 1178 days. |
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| Secondary | Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year | Participants could use oral levodopa-carbidopa for scheduled or supplemental bedtime/overnight doses after the pump was disconnected for the night, or as rescue medication in case of acute deterioration caused by failure of the LCIG system such as tubes and/or the pump or the onset of an acute illness. The initiation of additional concomitant PD medication was allowed at the discretion of the Investigator if medically indicated. | Participants who received LCIG during each year in this extension study | Posted | Count of Participants | Participants | Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10, > Year 10 (maximum time on treatment was approximately 11.5 years). |
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| Secondary | Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment | The PD symptom diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "Off" time was defined as time when medication had worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A negative change for "off" time indicates improvement. The PD diary assessment was implemented with Protocol amendment 4 (December 2013) for participants at United States (US) sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | hours | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment | The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Non-troublesome dyskinesia does not interfere with function or cause meaningful discomfort. "On" time without troublesome dyskinesia is the sum of "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | hours | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment | The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Troublesome dyskinesia interferes with function or causes meaningful discomfort. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | hours | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | score on a scale | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | score on a scale | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). UPDRS Part III consists of 14 questions. Questions 20 - 26 are multi-part questions in that they are evaluated separately for multiple body parts. Counting each of these assessments leads to a total of 27 answers for Part III. The UPDRS Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-Point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | score on a scale | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The UPDRS total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I - III of the scale. The total score ranges from 0 - 176 with 176 representing the worst (total) disability, and 0 no disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | score on a scale | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias). The UPDRS Part IV Score is the sum of all answers to the 11 questions that comprise Part IV, 4 of which are measured on a 5-point scale (0 - 4) and 7 which are measured on a 2-point scale (0 - 1). The Part IV score ranges from 0 - 23 with higher scores associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | score on a scale | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias); and The UPDRS Part IV dyskinesia Score is the sum of Questions 32 (What proportion of the waking day are dyskinesias present?), 33 (How disabling are the dyskinesias? ), and 34 (How painful are the dyskinesias?) on UPDRS Part IV, each of which are measured on a 5-point scale (0-4). The Part IV dyskinesia score ranges from 0 - 12 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | score on a scale | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
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| Secondary | Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment | The PDQ-39 is a self-administered questionnaire that comprises 39 items addressing the following eight domains of health that patients consider to be adversely affected by the disease:
Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness. The PDQ-39 summary index (range 0-100) includes responses to all 39 items. A negative change indicates improvement. | Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study | Posted | Mean | Standard Deviation | score on a scale | Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days. |
|
From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levodopa-Carbidopa Intestinal Gel | Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available. | 59 | 262 | 159 | 262 | 223 | 262 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIOPULMONARY FAILURE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| EXTRASYSTOLES | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| VENOUS STASIS RETINOPATHY | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BEZOAR | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DUODENAL ULCER | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| GIANT CELL EPULIS | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| INTESTINAL DILATATION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| INTUSSUSCEPTION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| JEJUNAL ULCER | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OESOPHAGEAL FOOD IMPACTION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OESOPHAGEAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PERITONITIS | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMOPERITONEUM | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RECTAL PROLAPSE | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| VOLVULUS | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| COMPLICATION OF DEVICE INSERTION | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEVICE BREAKAGE | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEVICE DISLOCATION | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEVICE MATERIAL ISSUE | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEVICE OCCLUSION | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MEDICAL DEVICE SITE REACTION | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| NECROSIS | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHOLANGITIS SCLEROSING | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| CATHETER SITE INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| CORONA VIRUS INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| GANGRENE | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| PELVIC ABSCESS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| POST PROCEDURAL SEPSIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| PYOTHORAX | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| WOUND INFECTION PSEUDOMONAS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| WOUND INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| EXTRADURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| HEAT STROKE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| MEDICATION ERROR | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| PERIPROSTHETIC FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| PERIPROSTHETIC OSTEOLYSIS | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| POST-TRAUMATIC PAIN | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| PROCEDURAL SITE REACTION | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| PUBIS FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| BLOOD MAGNESIUM DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| BLOOD POTASSIUM DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMATOCRIT DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| HEART RATE DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| OXYGEN SATURATION DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| URINE OUTPUT DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| VITAMIN B6 DEFICIENCY | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CAMPTOCORMIA | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OSTEOCHONDROSIS | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SCOLIOSIS | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ACUTE LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MENTAL IMPAIRMENT | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MONOPLEGIA | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MYOCLONUS | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ON AND OFF PHENOMENON | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PARKINSON'S DISEASE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PARKINSONIAN CRISIS | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RUPTURED CEREBRAL ANEURYSM | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SEDATION | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ABNORMAL BEHAVIOUR | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| AFFECTIVE DISORDER | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| AGGRESSION | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DOPAMINE DYSREGULATION SYNDROME | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HALLUCINATION | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PARANOIA | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SLEEP ATTACKS | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BLADDER NECK OBSTRUCTION | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| STRESS URINARY INCONTINENCE | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PELVIC HAEMATOMA | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BRONCHITIS CHRONIC | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHOKING | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PLEURAL DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY ACIDOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| EXCESSIVE GRANULATION TISSUE | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPOVOLAEMIC SHOCK | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SUBGALEAL HAEMATOMA | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| COMPLICATION OF DEVICE INSERTION | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| INCISION SITE ERYTHEMA | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| POST PROCEDURAL DISCHARGE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| PROCEDURAL SITE REACTION | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| BLOOD HOMOCYSTEINE INCREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| VITAMIN B6 DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| VITAMIN B6 INCREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| VITAMIN B6 DEFICIENCY | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DYSKINESIA | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PARKINSON'S DISEASE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HALLUCINATION | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SLEEP ATTACKS | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| EXCESSIVE GRANULATION TISSUE | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2016 | Oct 20, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Black of African Heritage or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Title | Measurements |
|---|---|
|
| Severe TEAE |
|
| TEAE leading to premature study discontinuaton |
|
| TEAE leading to death |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Year 4 |
Participants who received LCIG during Year 4 of the extension study. |
| OG004 | Year 5 | Participants who received LCIG during Year 5 of the extension study. |
| OG005 | Year 6 | Participants who received LCIG during Year 6 of the extension study. |
| OG006 | Year 7 | Participants who received LCIG during Year 7 of the extension study. |
| OG007 | Year 8 | Participants who received LCIG during Year 8 of the extension study. |
| OG008 | Year 9 | Participants who received LCIG during Year 9 of the extension study. |
| OG009 | Year 10 | Participants who received LCIG during Year 10 of the extension study. |
| OG010 | > Year 10 | Participants who received LCIG after Year 10 of the extension study. |
|
|
|
|
|
|
|
|
|
|
|
|
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