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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004865-26 | EudraCT Number |
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The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.
The study will consist of 3 sequential parts:
Part 1: Screening period. The screening period will consist of 3 visits, Visit 1 (V1), Visit 2 ([V2] [optional]) and the Randomization Visit (V3) in which the participant will be assessed to determine eligibility. The duration of the Screening Period can be between 30 to 67 days to accommodate the required procedures, training and collection of diaries, and to allow for stabilization of anti-PD medications and medications to treat NMS. All anti-PD medications and medications to treat NMS are required to be stable for a minimum of 30 days prior to randomization.
Part 2: Treatment period. Those participants randomized to OMT at the end of V3 will remain on their current optimized regimen. The day after randomization will be considered Day 1 of their treatment period and participants will have study visits at the end of Weeks 2, 6, 12, and 26. All participants randomized to the LCIG group should have all anti-PD medications, with the exception of levodopa formulations, tapered off within 14 days after randomization. Optional nasojujunal (NJ) and/or percutaneous endoscopic gastrostomy with a jejunal tube (PEG-J) placement will then occur. After that, the participant may begin initiation and titration of LCIG infusion to be adjusted to obtain the optimal clinical response. The day of initial NJ or PEG-J placement will be considered Day 1 for participants in the LCIG group. Study visits happen at the end of Weeks 2, 6, 12, and 26.
Part 3: Extension/Transition Period. Eligible participants who complete the 26 week study may continue into the Extension Period of the study. Participants in the LCIG arm will have study drug dispensation every 4 weeks and will have study visits every 6 months. Participants from the OMT arm will undergo the NJ (optional) and PEG-J procedures, titration, plus have visits at 2 weeks, 6 weeks, 3 months and 6 months post NJ or PEG-J. Participants will then continue to receive study drug every 4 weeks and will have study visits every 6 months until Duodopa is commercially available. Transition to a Post-Trial Access protocol will be possible if Duodopa does not become commercially available in a location.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized Medical Treatment (OMT) | Active Comparator | Participants randomized to continue OMT remain on their current optimized regimen. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG. |
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| Levodopa-Carbidopa Intestinal Gel (LCIG) | Experimental | Participants randomized to LCIG at an individually optimized dose (after NJ and/or PEG-J placement), in accordance with the LCIG approved product label for countries participating in the study. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion is expected to run over a period of 16 consecutive hours each day. Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimized Medical Treatment | Drug | Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 26 in the NMSS Total Score | The NMSS consists of 30 questions in 9 domains (cardiovascular/falls, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, GI tract, urinary, sexual function, miscellaneous). Score of each question is calculated by multiplying severity*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Total score is the sum of 9 domains, and ranges from 0 to 360, with a lower value indicating a more desirable outcome. Repeated-measure analysis. | Baseline, Week 26 |
| Change From Baseline to Week 26 in the Modified PDSS-2 Total Score | The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 26 in Parkinson's Disease Questionnaire (PDQ-8) Summary Index Score | The PDQ-8 is a disease-specific instrument designed to measure aspects of health relevant to PD. Eight questions including the mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort are assessed on a 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Summary index score is the sum of each question divided by 32 and multiplied by 100. Scores range from 0 to 100 with lower values desirable. |
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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 |
|---|---|---|---|---|---|---|
| Parkinson's and Movement /ID# 161596 | Fountain Valley | California | 92708 | United States | ||
| Boca Raton Regional Hospital /ID# 200056 |
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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
After a 30- to 67-day Screening Period for required procedures, training, and medication stabilization, eligible participants were randomized to Optimized Medical Treatment (OMT) or Levodopa-Carbidopa Intestinal Gel (LCIG) for a 26-week Treatment Period. Before Treatment Period Day 1, LCIG participants had a percutaneous endoscopic gastrostomy with a jejunal extension (PEG-J; with an initial, optional, temporary nasojejunal [NJ] tube placement to titrate the dose of LCIG prior to the PEG-J).
This study was conducted at 32 sites in 9 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Optimized Medical Treatment | Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment Period |
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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 | May 31, 2017 | May 7, 2021 |
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| Levodopa-Carbidopa Intestinal Gel | Drug |
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| Nasojejunal (NJ) tube | Device | optional prior to PEG-J placement |
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| Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube | Device |
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| Baseline, Week 26 |
| Clinical Global Impression of Change (CGI-C) Final Score | CGI-C score is a clinician's impression of a subject's change in status on a 7-point scale (1 = very much improved, 2 = much improved, 3 = minimally Improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse). Scores range from 1 to 7, with lower score desirable. | End of Treatment Period (up to Week 26) |
| Change From Baseline at Week 26 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score | UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease of 42 total questions. Part I (Questions 1 - 4), Part II (Questions 5 - 17), Part III (Questions 18 - 31), and Part IV (Questions 32 - 42). Questions 35 - 38 and 40 - 42 are 2-point (0 and 1), all other questions are 5-point (0 - 4). Part II scores range from 0 to 52 with lower value desirable. | Baseline, Week 26 |
| Change From Baseline to Week 26 in the NMSS Domain Scores | The NMSS consists of 30 questions in 9 domains. Score of each question is calculated by multiplying severity*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Cardiovascular/falls scores range from 0 - 24 with lower value desirable. Sleep/fatigue scores range from 0 - 48 with lower value desirable. Mood/cognition scores range from 0 - 72 with lower value desirable. Perceptual problems/hallucinations scores range from 0 - 36 with lower value desirable. Attention/memory scores range from 0 - 36 with lower value desirable. Gastrointestinal tract scores range from 0 - 36 with lower value desirable. Urinary scores range from 0 - 36 with lower value desirable. Sexual function scores range from 0 - 24 with lower value desirable. Miscellaneous scores range from 0 - 48 with lower value desirable. Repeated-measure analysis. | Baseline, Week 26 |
| Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores | The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis. | Baseline, Week 26 |
| Change From Baseline at Week 26 in UPDRS Parts I, III, and IV Score | UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease of 42 total questions. Part I (Questions 1 - 4), Part II (Questions 5 - 17), Part III (Questions 18 - 31), and Part IV (Questions 32 - 42). Questions 35 - 38 and 40 - 42 are 2-point (0 and 1), all other questions are 5-point (0 - 4). Part I is the sum of Questions 1 - 4; scores range from 0 to 16 with lower value desirable. Part III is the sum of Questions 18 - 31 (Questions 20 - 26 apply to multiple body parts, resulting in 27 answers total); scores range from 0 to 108 with lower value desirable. Part IV is the sum of Questions 32 - 42; scores range from 0 to 23 with lower value desirable. | Baseline, Week 26 |
| Change From Baseline at Week 26 in Parkinson's Anxiety Scale (PAS) Total Score | PAS is a 12-item scale developed specifically to measure severity in anxiety in Parkinson's disease for the following items: Feeling anxious or nervous; Feeling tense or stressed; Being unable to relax; Excessive worrying about everyday matters; Fear of something bad, or even the worst, happening; Panic or intense fear; Shortness of breath; Heart palpitations or heart beating fast; Fear of losing control; Social situations; Public settings; Specific objects or situations. Severity for each item is rated as: 0, Never; 1 Rarely; 2, Sometimes; 3, Often; 4, Nearly always. Total score is the sum of the12 item scores, with a range of 0 to 48; a lower value is desirable. | Baseline, Week 26 |
| Change From Baseline at Week 26 in Geriatric Depression Scale (GDS-15) Score | The GDS-15 is a short, self-report reliable and valid screening instrument for depression in the elderly of 15 yes/no questions: 1) Satisfied with life 2) Dropped many activities and interests 3) Life is empty 4) Often get bored 5) In good spirits most of the time 6) Afraid that something bad is going to happen 7) Feel happy most of the time 8) Often feel helpless 9) Prefer to stay at home, rather than going out and doing things 10) Feel that have more problems with memory than most 11) Think it is wonderful to be alive now 12) Feel worthless 13) Feel full of energy 14) Situation is hopeless 15) Most subjects are better off. Answers of 'yes' to questions 2, 3, 4, 6, 8, 9, 10, 12, 14, 15 are scored 1 point. Answers of 'no' to questions 1, 5, 7, 11, 13 are scored 1 point. The 15 items are summed and scores range from 0 - 15 with lower value desirable. | Baseline, Week 26 |
| Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score | The KPPS score is a clinical PD-specific pain scale of 14 items addressing the following 7 domains: musculoskeletal pain, chronic pain, fluctuation-related pain, nocturnal pain, orofacial pain, neuropathic pain, radicular pain. Each domain item is scored by severity (0, none to 3, very severe) multiplied by frequency (0, never to 4, all the time) resulting in a subscore of 0 - 12 (with lower value desirable), the sum of the 14 items gives the total score with a range from 0 to 168 with lower value desirable. | Baseline, Week 26 |
| Patient Global Impression of Change (PGIC) Final Score | The PGIC is a 7-point response scale. The participant was asked by the Investigator or qualified designee to rate their change in status using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. PGIC score ranges from 1 to 7 with lower score desirable. | End of Treatment Period (up to Week 26) |
| Boca Raton |
| Florida |
| 33486 |
| United States |
| University of Florida Neurolog /ID# 168699 | Jacksonville | Florida | 32209 | United States |
| Parkinson's Disease Treatment Center of Southwest Florida /ID# 168085 | Port Charlotte | Florida | 33980 | United States |
| Rush University Medical Center /ID# 168088 | Chicago | Illinois | 60612 | United States |
| St. Luke's Health System /ID# 168706 | Kansas City | Missouri | 64111 | United States |
| Central Texas Neurology Consul /ID# 168087 | Round Rock | Texas | 78681 | United States |
| Inland Northwest Research /ID# 200113 | Spokane | Washington | 99202-1342 | United States |
| Westmead Hospital /ID# 136575 | Westmead | New South Wales | 2145 | Australia |
| Royal Adelaide Hospital /ID# 136577 | Adelaide | South Australia | 5000 | Australia |
| Royal Melbourne Hospital /ID# 136780 | Parkville | Victoria | 3050 | Australia |
| Goulburn Valley Hospital /ID# 164202 | Shepparton | Victoria | 3630 | Australia |
| University of Alberta /ID# 136586 | Edmonton | Alberta | T6G 2X8 | Canada |
| The Ottawa Hospital /ID# 139341 | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto Western Hospital /ID# 136585 | Toronto | Ontario | M5T 2S8 | Canada |
| Central Hospital Bremerhaven /ID# 136573 | Bremerhaven | 27574 | Germany |
| 251 Airforce General Hospital /ID# 160594 | Athens | Attica | 11525 | Greece |
| Mediterraneo Hospital /ID# 208042 | Glyfada | 16675 | Greece |
| A.O. Univ. Ospedali Riuniti /ID# 135964 | Ancona | The Marches | 60126 | Italy |
| Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 136789 | Bologna | 40139 | Italy |
| A.O.U. Ospedali Riuniti di Fog /ID# 136792 | Foggia | 71100 | Italy |
| A.O.U. Policlinico G. Martino /ID# 136790 | Messina | 98125 | Italy |
| Ospedale S.Maria della Miseri /ID# 160609 | Perugia | 06132 | Italy |
| Azienda Sanitaria Locale di /ID# 160608 | Ponderano,biella | 13875 | Italy |
| Azienda Policlinico Umberto I /ID# 201223 | Roma | 00161 | Italy |
| Severance Hospital /ID# 163019 | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Seoul National University Hospital /ID# 162990 | Seoul | 03080 | South Korea |
| Asan Medical Center /ID# 163018 | Seoul | 05505 | South Korea |
| Hospital Universitario de Bellvitge /ID# 136579 | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| CHU Insular-Materno Infantil /ID# 136783 | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| Hospital Clinic de Barcelona /ID# 137689 | Barcelona | 08036 | Spain |
| Hospital Santa Creu i Sant Pau /ID# 136581 | Barcelona | 08041 | Spain |
| Hospital Puerta del Mar /ID# 157977 | Cadiz | 11009 | Spain |
| Hospital Universitario Virgen de las Nieves /ID# 136583 | Granada | 18014 | Spain |
| Hospital Universitario Ramon y Cajal /ID# 136784 | Madrid | 28034 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 145624 | Seville | 41013 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 136722 | Valencia | 46026 | Spain |
| Karolinska Univ Sjukhuset /ID# 135961 | Solna | 17176 | Sweden |
| FG001 | LCIG | Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG. |
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| COMPLETED | Completed 26-week Treatment Period |
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| NOT COMPLETED |
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| Extension/Transition Period |
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Safety dataset: all participants randomized to OMT, and all participants randomized to LCIG who had study device (NJ and/or PEG-J) placement.
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| ID | Title | Description |
|---|---|---|
| BG000 | Optimized Medical Treatment | Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG. |
| BG001 | LCIG | Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Non-Motor Symptoms Scale (NMSS) Total Score | The NMSS consists of 30 questions in 9 domains (cardiovascular/falls, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastrointestinal (GI) tract, urinary, sexual function, miscellaneous). Score of each question is calculated by multiplying severity*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Total score is the sum of 9 domains, and ranges from 0 to 360, with a lower value indicating a more desirable outcome. | Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table. | Mean | Standard Deviation | score on a scale |
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| Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score | The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. | Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table. | Mean | Standard Deviation | score on a scale |
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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 | Change From Baseline to Week 26 in the NMSS Total Score | The NMSS consists of 30 questions in 9 domains (cardiovascular/falls, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, GI tract, urinary, sexual function, miscellaneous). Score of each question is calculated by multiplying severity*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Total score is the sum of 9 domains, and ranges from 0 to 360, with a lower value indicating a more desirable outcome. Repeated-measure analysis. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with baseline and a post-baseline measurement are reported in this table. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Primary | Change From Baseline to Week 26 in the Modified PDSS-2 Total Score | The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with baseline and a post-baseline measurement are reported in this table. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Change From Baseline to Week 26 in Parkinson's Disease Questionnaire (PDQ-8) Summary Index Score | The PDQ-8 is a disease-specific instrument designed to measure aspects of health relevant to PD. Eight questions including the mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort are assessed on a 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Summary index score is the sum of each question divided by 32 and multiplied by 100. Scores range from 0 to 100 with lower values desirable. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Clinical Global Impression of Change (CGI-C) Final Score | CGI-C score is a clinician's impression of a subject's change in status on a 7-point scale (1 = very much improved, 2 = much improved, 3 = minimally Improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse). Scores range from 1 to 7, with lower score desirable. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with an assessment are reported in this table. | Posted | Least Squares Mean | Standard Error | score on a scale | End of Treatment Period (up to Week 26) |
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| Secondary | Change From Baseline at Week 26 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score | UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease of 42 total questions. Part I (Questions 1 - 4), Part II (Questions 5 - 17), Part III (Questions 18 - 31), and Part IV (Questions 32 - 42). Questions 35 - 38 and 40 - 42 are 2-point (0 and 1), all other questions are 5-point (0 - 4). Part II scores range from 0 to 52 with lower value desirable. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Change From Baseline to Week 26 in the NMSS Domain Scores | The NMSS consists of 30 questions in 9 domains. Score of each question is calculated by multiplying severity*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Cardiovascular/falls scores range from 0 - 24 with lower value desirable. Sleep/fatigue scores range from 0 - 48 with lower value desirable. Mood/cognition scores range from 0 - 72 with lower value desirable. Perceptual problems/hallucinations scores range from 0 - 36 with lower value desirable. Attention/memory scores range from 0 - 36 with lower value desirable. Gastrointestinal tract scores range from 0 - 36 with lower value desirable. Urinary scores range from 0 - 36 with lower value desirable. Sexual function scores range from 0 - 24 with lower value desirable. Miscellaneous scores range from 0 - 48 with lower value desirable. Repeated-measure analysis. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with baseline and a post-baseline measurement are reported in this table. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores | The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with baseline and a post-baseline measurement are reported in this table. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Change From Baseline at Week 26 in UPDRS Parts I, III, and IV Score | UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease of 42 total questions. Part I (Questions 1 - 4), Part II (Questions 5 - 17), Part III (Questions 18 - 31), and Part IV (Questions 32 - 42). Questions 35 - 38 and 40 - 42 are 2-point (0 and 1), all other questions are 5-point (0 - 4). Part I is the sum of Questions 1 - 4; scores range from 0 to 16 with lower value desirable. Part III is the sum of Questions 18 - 31 (Questions 20 - 26 apply to multiple body parts, resulting in 27 answers total); scores range from 0 to 108 with lower value desirable. Part IV is the sum of Questions 32 - 42; scores range from 0 to 23 with lower value desirable. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with baseline and a post-baseline measurement are reported in this table. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Change From Baseline at Week 26 in Parkinson's Anxiety Scale (PAS) Total Score | PAS is a 12-item scale developed specifically to measure severity in anxiety in Parkinson's disease for the following items: Feeling anxious or nervous; Feeling tense or stressed; Being unable to relax; Excessive worrying about everyday matters; Fear of something bad, or even the worst, happening; Panic or intense fear; Shortness of breath; Heart palpitations or heart beating fast; Fear of losing control; Social situations; Public settings; Specific objects or situations. Severity for each item is rated as: 0, Never; 1 Rarely; 2, Sometimes; 3, Often; 4, Nearly always. Total score is the sum of the12 item scores, with a range of 0 to 48; a lower value is desirable. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with baseline and a post-baseline measurement are reported in this table. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Change From Baseline at Week 26 in Geriatric Depression Scale (GDS-15) Score | The GDS-15 is a short, self-report reliable and valid screening instrument for depression in the elderly of 15 yes/no questions: 1) Satisfied with life 2) Dropped many activities and interests 3) Life is empty 4) Often get bored 5) In good spirits most of the time 6) Afraid that something bad is going to happen 7) Feel happy most of the time 8) Often feel helpless 9) Prefer to stay at home, rather than going out and doing things 10) Feel that have more problems with memory than most 11) Think it is wonderful to be alive now 12) Feel worthless 13) Feel full of energy 14) Situation is hopeless 15) Most subjects are better off. Answers of 'yes' to questions 2, 3, 4, 6, 8, 9, 10, 12, 14, 15 are scored 1 point. Answers of 'no' to questions 1, 5, 7, 11, 13 are scored 1 point. The 15 items are summed and scores range from 0 - 15 with lower value desirable. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score | The KPPS score is a clinical PD-specific pain scale of 14 items addressing the following 7 domains: musculoskeletal pain, chronic pain, fluctuation-related pain, nocturnal pain, orofacial pain, neuropathic pain, radicular pain. Each domain item is scored by severity (0, none to 3, very severe) multiplied by frequency (0, never to 4, all the time) resulting in a subscore of 0 - 12 (with lower value desirable), the sum of the 14 items gives the total score with a range from 0 to 168 with lower value desirable. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 |
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| Secondary | Patient Global Impression of Change (PGIC) Final Score | The PGIC is a 7-point response scale. The participant was asked by the Investigator or qualified designee to rate their change in status using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. PGIC score ranges from 1 to 7 with lower score desirable. | Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with an assessment are reported in this table. | Posted | Least Squares Mean | Standard Error | score on a scale | End of Treatment Period (up to Week 26) |
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All adverse events are reported from the time of randomization until 30 days following last OMT dose, last study visit, discontinuation of study drug administration, removal of the PEG-J tube or Last LCIG Commercial Transition Visit have elapsed. Median duration of follow-up was 191 days for OMT and 565 days for LCIG in the Treatment Period, and was 1366 days for OMT -> LCIG and 1003.5 days for LCIG -> LCIG in the Extension/Transition period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Optimized Medical Treatment (OMT) | Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. | 0 | 44 | 4 | 44 | 13 | 44 |
| EG001 | LCIG | Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day. | 0 | 45 | 9 | 43 | 33 | 43 |
| EG002 | Extension/Transition OMT->LCIG | Participants randomized to continue OMT in the United States or South Korea who elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG. | 1 | 10 | 2 | 10 | 6 | 10 |
| EG003 | Extension/Transition LCIG->LCIG | Participants randomized to LCIG in the United States or South Korea who elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG. | 0 | 14 | 1 | 14 | 4 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AORTIC VALVE STENOSIS | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| PNEUMOPERITONEUM | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 23.0 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 23.0 | Systematic Assessment |
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| BACTERAEMIA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| PERITONITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| STOMA SITE INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| PATELLA FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| NEURALGIA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| PARKINSON'S DISEASE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CATARACT NUCLEAR | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| NORMAL TENSION GLAUCOMA | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| DUODENAL ULCER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| GASTRIC MUCOSAL LESION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 23.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 23.0 | Systematic Assessment |
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| ASYMPTOMATIC COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| STOMA SITE CELLULITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| STOMA SITE INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| STOMA SITE DERMATITIS | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| STOMA SITE DISCHARGE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| STOMA SITE HYPERGRANULATION | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| STOMA SITE PAIN | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| VITAMIN B6 DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
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| DYSKINESIA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| FREEZING PHENOMENON | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| PARKINSON'S DISEASE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| DEVICE DISLOCATION | Product Issues | MedDRA 23.0 | Systematic Assessment |
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| DEVICE MALFUNCTION | Product Issues | MedDRA 23.0 | Systematic Assessment |
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| AGITATION | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| DEPRESSED MOOD | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| HALLUCINATION | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| IMPULSE-CONTROL DISORDER | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| IMPULSIVE BEHAVIOUR | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| SLEEP ATTACKS | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| SOCIAL PROBLEM | Social circumstances | MedDRA 23.0 | Systematic Assessment |
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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 | Apr 11, 2018 | May 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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| Other, Not Specified |
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Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day. |
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Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated.
The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
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