Advanced Parkinson's DiseasePhase 2NCT01479127

Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease

A Phase 2 study testing ABT-SLV187, Oral Levodopa/Carbidopa and Infusion Pump: CADD-Legacy® 1400 Pump in people with Advanced Parkinson's Disease, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced Parkinson's disease (PD) patients with severe motor complications. The complications of medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be investigated. Read more about this study

Who is it for?: Ages 30 to 99 years
Conditions the study is for: Advanced Parkinson's Disease
What is being tested?: ABT-SLV187, Oral Levodopa/Carbidopa and Infusion Pump: CADD-Legacy® 1400 Pump
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: 8 participants
Where: No sites listed yet
Study dates: Oct 2011to Jul 2012
Phase: Phase 2
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Idiopathic PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank criteria
PD stage corresponds to 4 or 5 in the 'off' state according to the modified Hoehn \& Yahr (H \& Y) classification of disease severity
Levodopa-responsive subjects demonstrate some identifiable 'ON response' established by observation by Investigator and demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

Who cannot join

Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
Undergone surgery for the treatment of PD
Contraindications to levodopa
Subjects with any neurological deficit that may interfere with the study assessments

About this study

Official title: An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease

Conditions: Advanced Parkinson's Disease
Being tested: ABT-SLV187, Oral Levodopa/Carbidopa, Infusion Pump: CADD-Legacy® 1400 Pump, NJ-Tube: Silicon ED Tube, Adaptor: Hakko Adaptor
Keywords: Levodopa-carbidopa intestinal gel, Advanced Parkinson's disease, Severe motor fluctuations, Dyskinesia
Medical subject headings: Dyskinesias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-SLV187Drug
Also called DUOPA™ (carbidopa and levodopa Enteral Suspension), DUODOPA®, Levodopa-carbidopa intestinal gel (LCIG)
Oral Levodopa/CarbidopaDrug
Tablet; contains 100 mg levodopa and 10 mg carbidopa
Infusion Pump: CADD-Legacy® 1400 PumpDevice
General infusion pump, manufactured by Smiths Medical (US)
NJ-Tube: Silicon ED TubeDevice
Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan)
Adaptor: Hakko AdaptorDevice
Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)

Study groups in NCT01479127
Study group	Role	What they receive
Levodopa-carbidopa intestinal gel	Experimental	Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms. Receives: Drug: ABT-SLV187; Drug: Oral Levodopa/Carbidopa; Device: Infusion Pump: CADD-Legacy® 1400 Pump; Device: NJ-Tube: Silicon ED Tube; Device: Adaptor: Hakko Adaptor

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period
AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.
Measured: During the Run-in period (up to approximately 28 days)
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period
AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.
Measured: From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period
M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period
M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period
M=male, F=female
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period
↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period
High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "Normal" State on the Treatment Response Scale (TRS) I
Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and Treatment Response Scale (TRS) under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia. The average of the neurologists' evaluations was calculated as a percentage of ratings in the "Normal" state (ie, "mild OFF" to "ON with mild dyskinesia") on the TRS I (total 10 assessments per day).
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Secondary outcomes (15)

Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "OFF" and "Dyskinesia" States on the TRS I and the "Normal," "OFF," and "Dyskinesia" States on the TRS II
Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and TRS under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia for TRS I, with the addition of Tremor at Rest and Postural Stability for TRS II. The average of the 3 neurologists' evaluations was calculated as a percentage of ratings in the "Normal" state (ie, "mild OFF" to "ON with mild dyskinesia"), the "Off" state ("moderate OFF" to "severe OFF"), and the "Dyskinesia" state ("ON with moderate dyskinesia" to "ON with severe dyskinesia") on the TRS I or II.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment
For each half hour period during 3 consecutive days prior to each assessment of the diary, participants (and/or their caregivers) entered into a diary whether they were asleep, in the ON motor state or in the OFF motor state in the following 5 grades: asleep, OFF, ON (no dyskinesia [D]), ON with non-troublesome dyskinesia (NTD), ON with troublesome dyskinesia (TD). 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. Dyskinetic time is time with involuntary muscle movement. The ON or OFF times were calculated as the average of 3 daily times from the diaries. w/o = without, w/ = with
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia
Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the video under blinded conditions using the following assessments: Tremor at Rest (UPDRS item #20), Finger Taps (UPDRS #23), Rapid Alternating Movement of Hands (UPDRS #25), Arising from Chair (UPDRS #27), Gait (UPDRS #29), Postural Stability (UPDRS #30), Body Bradykinesia and Hypokinesia (UPDRS #31), and Dyskinesia (evaluated with the Goetz Dyskinesia Rating Scale). The UPDRS score is the sum of the answers to individual questions, each of which are measured on a 5-point scale (0-4), with higher scores associated with more disability. The Goetz Dyskinesia Rating Scale is a 5-point scale of the severity of dyskinesias, from 0 (absent) to 4 (violent dyskinesias).
Measured: Baseline (Day -1), Endpoint (Day 21)
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores
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 ranges from 0-176, with 176 representing the worst (total) disability, and 0 no disability. The Part I Score is the sum of the answers to the 4 questions related to Mentation, Behavior and Mood, and ranges from 0-16. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. The Part IV Score is the sum of the answers to the 11 questions related to Complications of Therapy, and ranges from 0-23. The Part IV dyskinesia subscore ranges from 0-12. For each part of the UPDRS, higher scores are associated with more disability.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients, including Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort, as well as a Summary Index Total Score. Scores for each are 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 (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Modified Hoehn and Yahr Staging at Baseline and End of Treatment
Participant's ON and OFF states staged according to the Modified Hoehn and Yahr criteria, an 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. 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.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment
The Schwab and England scale was used to rate the subject's activities of daily living by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%).
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment
The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. 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: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187
Tmax of levodopa, carbidopa, and its metabolite 3-O-methyldopa (3-OMD) after administration of oral L/C tablets and intra-jejunal administration of ABT-SLV187.
Measured: Baseline (Day -1): pre-dose; 15, 30, 45, 60 mins post-morning dose; every 30 mins thereafter for 12 hrs. Day 21: pre-dose; 15, 30, 45, 60 mins post-infusion; every 30 mins from hrs 1 to 12 post-infusion; every 2 hrs from 12 to 16 hrs post-infusion.
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
Cmax, Cavg, Cmin, and Cmin (2-12 hours) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). Cmin values for levodopa and carbidopa during the 16 hours of infusion were observed either at time 0 or 15 min after start of the infusion and were a result of drug washout prior to establishment of infusion.
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
AUC0-12 and AUC0-16 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
AUC0-12/Dose0-12 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). AUC0-16/Dose0-16 of levodopa, carbidopa, and 3-OMD after administration of intra-jejunal administration of ABT-SLV187 (Day 21).
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
Degree of Fluctuation (calculated as [Cmax - Cmin] / Cavg)) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Ratio of Metabolite 3-OMD to Levodopa (M/P [AUC0-12]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
M/P (AUC0-12) after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period
Measured: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Jul 2012

First posted24 Nov 2011 (estimated)
Study startOct 2011
Primary completionJul 2012
Study completionJul 2012

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.
Other trials for Advanced Parkinson's DiseaseStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01479127
Sponsor's protocol ID: M12-925
Status last verified: Mar 2016
First submitted: 26 Sep 2011
Last updated: 21 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2016. 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 Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
ClinicalTrials.gov ID: NCT01479127
Acronym / sponsor ID: M12-925
Conditions: Advanced Parkinson's Disease
Keywords: Levodopa-carbidopa intestinal gel, Advanced Parkinson's disease, Severe motor fluctuations, Dyskinesia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Abbott Japan Co.,Ltd
Study start: Oct 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 24 Nov 2011 (estimated)
Results: Posted 15 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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	Experimental	Drug: ABT-SLV187, Drug: Oral Levodopa/Carbidopa, Device: Infusion Pump: CADD-Legacy® 1400 Pump, Device: NJ-Tube: Silicon ED Tube, Device: Adaptor: Hakko AdaptorFollowing a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.

Who may qualify

Ages: 30 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Idiopathic PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank criteria
PD stage corresponds to 4 or 5 in the 'off' state according to the modified Hoehn \& Yahr (H \& Y) classification of disease severity
Levodopa-responsive subjects demonstrate some identifiable 'ON response' established by observation by Investigator and demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

Key exclusion criteria (4 listed)

Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
Undergone surgery for the treatment of PD
Contraindications to levodopa
Subjects with any neurological deficit that may interfere with the study assessments

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
ABT-SLV187Also: DUOPA™ (carbidopa and levodopa Enteral Suspension), DUODOPA®, Levodopa-carbidopa intestinal gel (LCIG)	Drug	Levodopa-carbidopa intestinal gel
Oral Levodopa/CarbidopaTablet; contains 100 mg levodopa and 10 mg carbidopa	Drug	Levodopa-carbidopa intestinal gel
Infusion Pump: CADD-Legacy® 1400 PumpGeneral infusion pump, manufactured by Smiths Medical (US)	Device	Levodopa-carbidopa intestinal gel
NJ-Tube: Silicon ED TubeDevice used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan)	Device	Levodopa-carbidopa intestinal gel
Adaptor: Hakko AdaptorAccessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)	Device	Levodopa-carbidopa intestinal gel

Primary outcome

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period
Time frame: During the Run-in period (up to approximately 28 days)
AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period
Time frame: From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days
AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
M=male, F=female
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.
Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "Normal" State on the Treatment Response Scale (TRS) I
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and Treatment Response Scale (TRS) under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia. The average of the neurologists' evaluations was calculated as a percentage of ratings in the "Normal" state (ie, "mild OFF" to "ON with mild dyskinesia") on the TRS I (total 10 assessments per day).

15 secondary outcomes

Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "OFF" and "Dyskinesia" States on the TRS I and the "Normal," "OFF," and "Dyskinesia" States on the TRS II
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia
Time frame: Baseline (Day -1), Endpoint (Day 21)
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Modified Hoehn and Yahr Staging at Baseline and End of Treatment
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187
Time frame: Baseline (Day -1): pre-dose; 15, 30, 45, 60 mins post-morning dose; every 30 mins thereafter for 12 hrs. Day 21: pre-dose; 15, 30, 45, 60 mins post-infusion; every 30 mins from hrs 1 to 12 post-infusion; every 2 hrs from 12 to 16 hrs post-infusion.
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Ratio of Metabolite 3-OMD to Levodopa (M/P [AUC0-12]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period
Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Results and safety

Results posted to the registry on 15 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levodopa-carbidopa Intestinal Gel	8	5

Primary outcome: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period

Time frame: During the Run-in period (up to approximately 28 days). Number. Unit: participants

Measure	Oral Levodopa/Carbidopa Tablet n = 8
AE	7
AE at least possibly related to study drug/device	5
Severe AE	0
SAE	0
AE leading to discontinuation of study drug	1
SAE at least possibly drug or drug device-related	0
AE of special interest	0
AE caused by study drug	5

Population analysed: Full safety sample: participants who had at least one dose of oral levodopa-carbidopa study drug in the Run-in Period.

Primary outcome: Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period

Time frame: From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days. Number. Unit: participants

Measure	Levodopa-carbidopa Intestinal Gel n = 6
AE	4
AE at least possibly related to study drug/device	3
Severe AE	1
SAE	1
AE leading to discontinuation of study drug	1
SAE at least possiby drug or drug device-related	1
AE of special interest	2
AE caused by study drug	3

Population analysed: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

Primary outcome: Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period

Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21). Number. Unit: participants

Measure	Levodopa-carbidopa Intestinal Gel n = 6
Low PCS Hematocrit [%]: 39.8 M / 33.4 F	3
High PCS Hematocrit [%]: 51.8 M / 44.9 F	0
Low PCS Hemoglobin [g/dL]: 13.5 M / 11.3 F	3
High PCS Hemoglobin [g/dL]: 17.6 M / 15.2 F	0
Low PCS RBC Count [*10^4/µL]: 427 M / 376 F	3
High PCS RBC Count [*10^4/µL]: 570 M / 500 F	0
Low PCS WBC Count [/µL]: 3900 M / 3500 F	1
High PCS WBC Count [/µL]: 9800 M / 9100 F	0

Population analysed: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

Primary outcome: Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period

Time frame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21). Number. Unit: participants

Measure	Levodopa-carbidopa Intestinal Gel n = 6
Low PCS Blood urea nitrogen [mg/dL]: 6	0
High PCS Blood urea nitrogen [mg/dL]: 20	1
Low Creatinine [mg/dL]: 0.61 M / 0.47 F	2
High Creatinine [mg/dL]: 1.04 M / 0.79 F	0
Low PCS Total bilirubin [mg/dL]: 0.2	0
High PCS Total bilirubin [mg/dL]: 1.0	0
Low PCS Alanine aminotransferase [U/L]: 5	0
High PCS Alanine aminotransferase [U/L]: 40	0

Population analysed: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Levodopa-carbidopa Tablets	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
Levodopa-carbidopa Intestinal Gel	1 of 6 (16.7%)	4 of 6 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Yukihiro Kumamoto, MS study director

AbbVie Japan Co., Ltd

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-SLV187, Oral Levodopa/Carbidopa and Infusion Pump: CADD-Legacy® 1400 Pump in people with Advanced Parkinson's Disease, run by AbbVie (prior sponsor, Abbott).

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 3 inclusion and 4 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 21 Apr 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Mar 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?

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period (time frame: During the Run-in period (up to approximately 28 days)). The study lists 9 primary outcomes in all. 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 NCT01479127.

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 21 Apr 2016.