NCT01479127|CompletedPhase 2Results

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

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

AbbVie (prior sponsor, Abbott)ClinicalTrials.gov

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1 other identifier

M12-925

Study Type

interventional

Target

Locations

0 countries

Sites

N/A

Timeline

RegisteredNov 2011

StartedOct 2011

CompletionJul 2012

Brief 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.

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Oct 2011

Shorter than P25 for phase_2

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

September 26, 2011

Completed

5 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed

2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

3.7 years until next milestone

Results Posted

Study results publicly available

March 15, 2016

Completed

Last Updated

April 21, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

September 26, 2011

Results QC Date

February 15, 2016

Last Update Submit

March 23, 2016

Conditions

Advanced Parkinson's Disease

Keywords

Levodopa-carbidopa intestinal gelAdvanced Parkinson's diseaseSevere motor fluctuationsDyskinesia

Outcome Measures

Primary Outcomes (9)

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.
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.
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.
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.
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
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
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.
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.
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).
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
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
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
Baseline (Day -1), Endpoint (Day 21)
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores
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
Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
+10 more secondary outcomes

Study Arms (1)

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.

Drug: ABT-SLV187Drug: Oral Levodopa/CarbidopaDevice: Infusion Pump: CADD-Legacy® 1400 PumpDevice: NJ-Tube: Silicon ED TubeDevice: Adaptor: Hakko Adaptor

Interventions

ABT-SLV187DRUG

Also known as: DUOPA™ (carbidopa and levodopa Enteral Suspension), DUODOPA®, Levodopa-carbidopa intestinal gel (LCIG)