Trial · NCT02006121

Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease

NCT02006121, Phase 3, Completed, Britannia Pharmaceuticals Ltd.; results first posted 2019-07-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease. Trials, record NCT02006121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02006121

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease
NCT number: NCT02006121
Status: Completed
Phases: Phase 3
Enrollment: 107 participants, actual
Lead sponsor: Britannia Pharmaceuticals Ltd.
Conditions: Parkinson's Disease
Interventions: Apomorphine hydrochloride, Placebo
First posted: 2013-12-09
Last updated: 2019-07-08
Other registries' IDs: eudract:2013-000980-10
Results first posted: 2019-07-08

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change in Daily OFF Time From Baseline (Start of Blinded Treatment) to the End of Double-blind Phase (Visit 10) Based on Patient Diaries Using MMRM mITT Population	Baseline and 12 weeks	The least squares mean reduction (improvement) in OFF time as reported by the patient using the Hauser Parkinson's disease home diary. Patients categorised their motor symptoms into OFF, ON with dyskinesia, ON without troublesome dyskinesia or sleeping using half hour blocks over 24 hours. Daily OFF time was computed from the average of valid motor diaries from the two days preceding each visit. Correct diary completion was evaluated during screening and observed by the investigator to ensure patients could categorise their motor symptoms correctly. A diary was considered valid if no more than 4 half-hour periods were either absent or duplicated. There were no invalid diaries at Baseline or Week 12.
Secondary	Mean Change in Daily Time Spent "ON Without Troublesome Dyskinesia" From Baseline to the End of the Double-blind Phase (Visit 10), Based on Patient Diaries Using MMRM mITT Population	Baseline and 12 weeks	The least squares mean change in "ON time without troublesome dyskinesia" as reported by the patient using the Hauser Parkinson's disease home diary. Each half hour of the day categorised as OFF, ON with dyskinesia, ON without troublesome dyskinesia or asleep. "ON time without troublesome dyskinesia" measures good ON time for a Parkinson's disease patient.
Secondary	Patient Global Impression of Change (PGIC), Using the mITT Population	Baseline and 12 weeks	PGIC is a self-administered questionnaire measuring personal general state of health on a 7-point rating scale. The 7 ordinal categories from which patients must choose are 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', and 'very much worse. Results are presented as the % of patients who reported at least minimal improvement in general health status at week 12 compared to Baseline. A Wilcoxon range sum test was performed to test for treatment differences from baseline to end of 12 weeks' treatment period.
Secondary	Mean Change in Oral Levodopa Dose From Baseline to Visit 10 Using MMRM for the mITT Population	Baseline and 12 weeks	The least squares mean change in oral levodopa dose from Baseline to Visit 10 (week 12) was calculated excluding 3 centres who declined to participate in collecting the necessary details of PRN use of levodopa.
Secondary	Mean Change in Levodopa Equivalent Dose From Baseline to Visit 10 (Week 12) Using MMRM in the mITT Population	Baseline and 12 weeks	Levodopa equivalent dose is an indication of the burden of medication taken to control symptoms of Parkinson's disease with all medications other than levodopa itself being converted to a calculated levodopa dose using the methodology published by Tomlinson et al, 2010. The computation of LED excludes the study drug.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change in Daily OFF Time From Baseline (Start of Blinded Treatment) to the End of Double-blind Phase (Visit 10) Based on Patient Diaries Using MMRM mITT Population	Baseline and 12 weeks	All randomised patients excluding those who had major protocol deviations who received at least one dose of trial medication during the course of the trial and for whom any post-baseline efficacy assessment is available.	Hours	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in Daily Time Spent ON Without Troublesome Dyskinesia From Baseline to the End of the Double-blind Phase (Visit 10), Based on Patient Diaries Using MMRM mITT Population	Baseline and 12 weeks	All randomised patients excluding those who had major protocol deviations who received at least one dose of trial medication during the course of the trial and for whom any post-baseline efficacy assessment is available.	Hours	LEAST_SQUARES_MEAN
SECONDARY	Patient Global Impression of Change (PGIC), Using the mITT Population	Baseline and 12 weeks	All randomised patients excluding those who had major protocol deviations who received at least one dose of trial medication during the course of the trial and for whom any post-baseline efficacy assessment is available and who completed the PGIC questionnaire	% of participants	NUMBER
SECONDARY	Mean Change in Oral Levodopa Dose From Baseline to Visit 10 Using MMRM for the mITT Population	Baseline and 12 weeks	All patients who received at least one dose of randomized study medication and had at least one post-baseline observation for the primary endpoint	mg	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in Levodopa Equivalent Dose From Baseline to Visit 10 (Week 12) Using MMRM in the mITT Population	Baseline and 12 weeks	All randomized patients treated at least once with study medication and who had at least one post-baseline observation for the primary endpoint	mg	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Change in Daily OFF Time From Baseline (Start of Blinded Treatment) to the End of Double-blind Phase (Visit 10) Based on Patient Diaries Using MMRM mITT Population	Apomorphine Hydrochloride	-2.61	95% Confidence Interval -3.43 to -1.80	Hours
Mean Change in Daily OFF Time From Baseline (Start of Blinded Treatment) to the End of Double-blind Phase (Visit 10) Based on Patient Diaries Using MMRM mITT Population	Placebo	-0.75	95% Confidence Interval -1.66 to 0.16	Hours
Mean Change in Daily Time Spent ON Without Troublesome Dyskinesia From Baseline to the End of the Double-blind Phase (Visit 10), Based on Patient Diaries Using MMRM mITT Population	Apomorphine Hydrochloride	2.90	95% Confidence Interval 2.07 to 3.73	Hours
Mean Change in Daily Time Spent ON Without Troublesome Dyskinesia From Baseline to the End of the Double-blind Phase (Visit 10), Based on Patient Diaries Using MMRM mITT Population	Placebo	0.85	95% Confidence Interval -0.09 to 1.78	Hours
Patient Global Impression of Change (PGIC), Using the mITT Population	Apomorphine Hydrochloride	79.1		% of participants
Patient Global Impression of Change (PGIC), Using the mITT Population	Placebo	23.5		% of participants
Mean Change in Oral Levodopa Dose From Baseline to Visit 10 Using MMRM for the mITT Population	Apomorphine Hydrochloride	-242.09	95% Confidence Interval -346.58 to -137.61	mg
Mean Change in Oral Levodopa Dose From Baseline to Visit 10 Using MMRM for the mITT Population	Placebo	-76.46	95% Confidence Interval -185.17 to 32.25	mg
Mean Change in Levodopa Equivalent Dose From Baseline to Visit 10 (Week 12) Using MMRM in the mITT Population	Apomorphine Hydrochloride	-502.02	95% Confidence Interval -626.45 to -377.60	mg
Mean Change in Levodopa Equivalent Dose From Baseline to Visit 10 (Week 12) Using MMRM in the mITT Population	Placebo	-150.87	95% Confidence Interval -280.14 to -21.59	mg

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double Blind Phase	STARTED	Apomorphine Hydrochloride	54
Double Blind Phase	STARTED	Placebo	53
Double Blind Phase	COMPLETED	Apomorphine Hydrochloride	42
Double Blind Phase	COMPLETED	Placebo	29
Double Blind Phase	NOT COMPLETED	Apomorphine Hydrochloride	12
Double Blind Phase	NOT COMPLETED	Placebo	24
Open Label Phase	STARTED	Apomorphine Hydrochloride	84
Open Label Phase	STARTED	Placebo	0
Open Label Phase	COMPLETED	Apomorphine Hydrochloride	59
Open Label Phase	COMPLETED	Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events134

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Infusion site nodule	General disorders	Apomorphine Hydrochloride	46	98
other	Infusion site nodule	General disorders	Placebo	0	53
other	Infusion site erythema	General disorders	Apomorphine Hydrochloride	15	98
other	Infusion site erythema	General disorders	Placebo	2	53
other	Infusion site haematoma	General disorders	Apomorphine Hydrochloride	8	98
other	Infusion site haematoma	General disorders	Placebo	5	53
other	Fatigue	General disorders	Apomorphine Hydrochloride	6	98
other	Fatigue	General disorders	Placebo	1	53
other	Oedema peripheral	General disorders	Apomorphine Hydrochloride	7	98
other	Oedema peripheral	General disorders	Placebo	0	53

1 to 10 of 134Source ClinicalTrials.gov

See all 134 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Apomorphine Hydrochloride	0	98
Total, all-cause mortality	Placebo	0	53
Total, other adverse events	Apomorphine Hydrochloride	94	98
Total, other adverse events	Placebo	30	53
Total, serious adverse events	Apomorphine Hydrochloride	23	98
Total, serious adverse events	Placebo	2	53

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30055903	DERIVED	PubMed
33486139	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Apomorphine Hydrochloride vs Placebo: deaths from any cause	Trial comparisons
Apomorphine Hydrochloride vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02006121

GET https://conductscience.org/api/trials/v1/NCT02006121/events?page=2

API reference For AI assistants