Advanced Parkinson's DiseasePhase 3NCT01960842
A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications
A Phase 3 study testing Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump and PEG tube in people with Advanced Parkinson's Disease, run by AbbVie.
Trial summary
The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Advanced Parkinson's Disease
- What is being tested?
- Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump and PEG tube
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Mar 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.
- Subjects have 4 or 5 in modified Hohn and Yahr (H \& Y) classification of disease severity at "Off" state determined by the UPDRS Part V at Screening Visit 1.
- The subject's advanced Parkinson's disease must be levodopa-responsive as judged by the Investigator.
- Subjects have had optimal treatment with available Parkinson's disease medication as defined by local standards of care and, based upon the judgment of the Investigator, and their symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with available anti-parkinsonian pharmacological therapy when no further improvement is expected regardless of any additional manipulations of levodopa and/or other anti parkinsonian medication; this will be based on the Investigator's best clinical judgment.
- Presence of a recognizable "Off" and "On" state (motor fluctuations) as confirmed by UPDRS Part III (in both "On" and "Off" states), and by the Parkinson's Disease Diary© which must be observed and confirmed at Screening Visit 1.
- Subjects must be experiencing a minimum of 3 hours per day of "Off" time, as estimated by the Investigator and supported by the UPDRS at Screening Visit 1 and the Parkinson's Disease Diaries at baseline. The "Off" time must occur during a continuous 16-hour interval, including the portion of the day during which the subject is awake the majority of the time (e.g., 5 AM to 9 PM, 7 AM to 11 PM).
Who cannot join
- Parkinson's disease diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson's-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or the other neurodegenerative diseases that might mimic the symptoms of Parkinson's disease .
- Subjects who have undergone neurosurgery for the treatment of Parkinson's disease .
- Current primary psychiatric diagnosis of acute psychotic disorder or other uncontrolled primary psychiatric diagnoses, (e.g., bipolar disorder or major depressive disorder per Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria.
- Alzheimer's disease; or other significant cognitive impairment or dementia (defined as Mini-Mental State Examination (MMSE) total score < 24).
- Subject has significant current suicidal ideation within the previous year as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening or any history of suicide attempts.
- A low B12 level or low-normal B12 level (less than 300 pg/mL) with elevated methylmalonic acid (MMA). Note: Abnormal Vitamin B12 of questionable clinical significance (i.e., indeterminate or low normal results) prior to or at Screening Visit 2 require appropriate interpretation in conjunction with MMA and homocysteine laboratory values prior to proceeding further into the study.
About this study
Official title: An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication
The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease.
Read the detailed description
The study was composed of a screening period followed by 2 sequential on-treatment periods, as follows:
- Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (N-J) tube placement.
- N-J Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of N-J tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via N-J tube and infusion pump (participant was hospitalized for N-J tube placement but hospitalization was not required for entire duration of LCIG treatment optimization).
- PEG-J Period (12 weeks): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.
- Conditions
- Advanced Parkinson's Disease
- Being tested
- Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, PEG tube, J-tube
- Keywords
- levodopa, Advanced Parkinson's Disease, carbidopa, levodopa-carbidopa intestinal gel, Safety and Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa-carbidopa intestinal gelDrug
Also called ABT-SLV187, LCIG
Dose levels will be individually optimized. Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour)
CADD-Legacy® 1400 ambulatory infusion pumpDevice
PEG tubeDevice
percutaneous endoscopic gastrostomy tube
J-tubeDevice
jejunal tube
| Study group | Role | What they receive |
|---|---|---|
| Levodopa-Carbidopa Intestinal Gel (LCIG) | Experimental | All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour). Receives: Drug: Levodopa-carbidopa intestinal gel; Device: CADD-Legacy® 1400 ambulatory infusion pump; Device: PEG tube; Device: J-tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Normalized "Off" Time: Change From Baseline To The Final PEG-J Visit
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Secondary outcomes (19)
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for "on" time indicates improvement.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Clinical Global Impression - Change (CGI-I) Score at the Final PEG-J Visit
The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.
Measured: Final PEG-J Visit (up to week 12)
Patient Global Impression of Change (PGI-C) Score at the Final PEG-J Visit
The PGI-C is a 7-point response scale. The subjects were to rate their change in status from Screening Visit 1 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. The responses of "Minimally improved," "Much improved," and "Very much improved" on the PGI-C were used to define responders.
Measured: Final PEG-J Visit (up to week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions 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.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers 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.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for "on" time indicates improvement.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit
The PDQ-39 is a self-administered questionnaire which comprises 39 items (each question answered on a 5-point scale) addressing 8 domains of health in Parkinson's disease patients: Mobility (e.g., fear of falling when walking) includes 10 questions; Emotional Well-being (e.g., feelings of isolation) includes 6 questions; Stigma (e.g., social embarrassment) includes 4 questions; Social Support includes 3 questions; Cognition includes 4 questions; Communication includes 3 questions; and Bodily Discomfort includes 3 questions. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The 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 will range from 0 to176, with 176 representing the worst (total) disability, and 0 representing no disability.
Measured: Baseline and Final PEG-J Visit (up to Week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. 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 to 16 and higher scores are associated with more disability.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0 to 23 and higher scores are associated with more disability.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Average Daily Normalized "Off" Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Average Daily Normalized "Off" Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.
Measured: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. n= the number of participants with available data at each time point.
Measured: Baseline (end of screening period) and Weeks 2, 4, 6, 8, 10, and 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs (TEAEs) are defined as any event that began or worsened in severity after N-J placement. The investigator assessed the relationship of each event to the use of study drug as Reasonable Possibility or No Reasonable Possibility.
For more details on adverse events please see the AE section below.
Measured: From N-J placement to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days.
Number of Participants With Potentially Clinically Significant Vital Sign Parameters
Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), body temperature (Temp), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively.
Measured: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters
Terms abbreviated in the table include females (f), males (m), and femtoliters (fL).
Measured: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters
Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).
Measured: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG)
Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), QT interval corrected for heart rate using Fridericia's formula (QTcF), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively. n = the number of participants with available data at each time point.
Measured: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masayoshi Yanagawa, PhD, Study director, AbbVie Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960842
- Sponsor's protocol ID
- M12-921
- Status last verified
- Apr 2016
- First submitted
- 9 Oct 2013
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murata M, Mihara M, Hasegawa K, Jeon B, Tsai CH, Nishikawa N, Oeda T, Yokoyama M, Robieson WZ, Ryman D, Eaton S, Chatamra K, Benesh J. Efficacy and safety of levodopa-carbidopa intestinal gel from a study in Japanese, Taiwanese, and Korean advanced Parkinson's disease patients. NPJ Parkinsons Dis. 2016 Nov 3;2:16020. doi: 10.1038/npjparkd.2016.20. eCollection 2016.
PubMed 28725701
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication
- ClinicalTrials.gov ID
- NCT01960842
- Acronym / sponsor ID
- M12-921
- Conditions
- Advanced Parkinson's Disease
- Keywords
- levodopa, Advanced Parkinson's Disease, carbidopa, levodopa-carbidopa intestinal gel, Safety and Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Posted 20 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease.
Detailed description
The study was composed of a screening period followed by 2 sequential on-treatment periods, as follows:
- Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (N-J) tube placement.
- N-J Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of N-J tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via N-J tube and infusion pump (participant was hospitalized for N-J tube placement but hospitalization was not required for entire duration of LCIG treatment optimization).
- PEG-J Period (12 weeks): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levodopa-Carbidopa Intestinal Gel (LCIG) | Experimental | Drug: Levodopa-carbidopa intestinal gel, Device: CADD-Legacy® 1400 ambulatory infusion pump, Device: PEG tube, Device: J-tubeAll participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.
- Subjects have 4 or 5 in modified Hohn and Yahr (H \& Y) classification of disease severity at "Off" state determined by the UPDRS Part V at Screening Visit 1.
- The subject's advanced Parkinson's disease must be levodopa-responsive as judged by the Investigator.
- Subjects have had optimal treatment with available Parkinson's disease medication as defined by local standards of care and, based upon the judgment of the Investigator, and their symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with available anti-parkinsonian pharmacological therapy when no further improvement is expected regardless of any additional manipulations of levodopa and/or other anti parkinsonian medication; this will be based on the Investigator's best clinical judgment.
- Presence of a recognizable "Off" and "On" state (motor fluctuations) as confirmed by UPDRS Part III (in both "On" and "Off" states), and by the Parkinson's Disease Diary© which must be observed and confirmed at Screening Visit 1.
Key exclusion criteria (6 listed)
- Parkinson's disease diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson's-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or the other neurodegenerative diseases that might mimic the symptoms of Parkinson's disease .
- Subjects who have undergone neurosurgery for the treatment of Parkinson's disease .
- Current primary psychiatric diagnosis of acute psychotic disorder or other uncontrolled primary psychiatric diagnoses, (e.g., bipolar disorder or major depressive disorder per Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria.
- Alzheimer's disease; or other significant cognitive impairment or dementia (defined as Mini-Mental State Examination (MMSE) total score < 24).
- Subject has significant current suicidal ideation within the previous year as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening or any history of suicide attempts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa-carbidopa intestinal gelAlso: ABT-SLV187, LCIGDose levels will be individually optimized. Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour) | Drug | Levodopa-Carbidopa Intestinal Gel (LCIG) |
| CADD-Legacy® 1400 ambulatory infusion pump | Device | Levodopa-Carbidopa Intestinal Gel (LCIG) |
| PEG tubepercutaneous endoscopic gastrostomy tube | Device | Levodopa-Carbidopa Intestinal Gel (LCIG) |
| J-tubejejunal tube | Device | Levodopa-Carbidopa Intestinal Gel (LCIG) |
Primary outcome
Average Daily Normalized "Off" Time: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.
19 secondary outcomes
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Clinical Global Impression - Change (CGI-I) Score at the Final PEG-J Visit
Time frame: Final PEG-J Visit (up to week 12)
Patient Global Impression of Change (PGI-C) Score at the Final PEG-J Visit
Time frame: Final PEG-J Visit (up to week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline and Final PEG-J Visit (up to Week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Average Daily Normalized "Off" Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Average Daily Normalized "Off" Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit
Time frame: Baseline (end of screening period) and Weeks 2, 4, 6, 8, 10, and 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From N-J placement to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days.
Number of Participants With Potentially Clinically Significant Vital Sign Parameters
Time frame: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters
Time frame: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters
Time frame: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG)
Time frame: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28725701Murata M, Mihara M, Hasegawa K, Jeon B, Tsai CH, Nishikawa N, Oeda T, Yokoyama M, Robieson WZ, Ryman D, Eaton S, Chatamra K, Benesh J. Efficacy and safety of levodopa-carbidopa intestinal gel from a study in Japanese, Taiwanese, and Korean advanced Parkinson's disease patients. NPJ Parkinsons Dis. 2016 Nov 3;2:16020. doi: 10.1038/npjparkd.2016.20. eCollection 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masayoshi Yanagawa, PhD study director
AbbVie Japan
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump and PEG tube in people with Advanced Parkinson's Disease, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Normalized "Off" Time: Change From Baseline To The Final PEG-J Visit (time frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.