This trial is active, not recruiting.

Condition parkinson's disease
Treatments apomorphine hydrochloride, placebo
Phase phase 3
Sponsor Britannia Pharmaceuticals Ltd.
Start date December 2013
End date June 2016
Trial size 107 participants
Trial identifier NCT02006121, 2013-000980-10, CT-37527-13-0124


The main purpose of this study is to investigate the efficacy of apomorphine subcutaneous infusion compared to placebo in advanced Parkinson's Disease patients.

The secondary purpose of this study is to investigate the safety and tolerability of apomorphine subcutaneous therapy.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Apo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe
apomorphine hydrochloride Apo-go
Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe
(Placebo Comparator)
Placebo: saline infusion
Sodium chloride 9 mg/ml

Primary Outcomes

Absolute change in time spent "OFF" from baseline to the end of 12 weeks treatment period based on patient diaries
time frame: after 12 weeks of treatment

Secondary Outcomes

Evaluation of adverse events and local tolerability
time frame: 1 year
Skin changes
time frame: 1 year
Full blood count
time frame: 1 year
Epworth Sleepiness Scale
time frame: 1 year
Questionnaire for Impulsive-Compulsive Disorders in Parkinson`s Disease
time frame: 1 year

Eligibility Criteria

Male or female participants at least 30 years old.

Inclusion Criteria: Male or female patients aged ≥30 - Diagnosis of idiopathic Parkinson's disease of >3 years' duration, defined by the UK Brain Bank criteria (with the exception of >1 affected relative being allowed), without any other known or suspected cause of Parkinsonism - Hoehn & Yahr stage up to 3 in the ON and 2 to 5 in the OFF state - Motor fluctuations not adequately controlled on medical treatment including L-dopa which was judged to be optimal by the treating physician - Average of OFF time>= 3 h/day based on screening and baseline diary entries with no day with < 2 hours of OFF time recorded - Stable medication regimen, with a stable dose of L-dopa administered in at least 4 intakes, for at least 28 days prior to baseline. All oral or transdermal antiparkinsonian drugs are permitted, with the exception of budipine. This regimen may include the use of L-dopa /DDCI rescue medication if this occurs up to 2 times a day, at doses of up to 200 mg L-dopa/day - Patients must be able to differentiate between the ON and OFF state and between troublesome and non-troublesome dyskinesias - Male and female patients must be compliant with a highly effective contraceptive method (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method) during the study and for 9 months long-term follow-up period, if sexually active - Females of childbearing potential must have a negative serum hCG pregnancy test at screening - Ability to accurately complete a paper diary on designated days (with assistance from caregivers, if required), recording periods when they are "ON without troublesome dyskinesia", "ON with troublesome dyskinesia", OFF, and sleeping - Written informed consent prior to enrolment, after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the study treatments - Patients considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator Exclusion Criteria: - High suspicion of other parkinsonian syndromes - Presence of severe freezing or clinically relevant postural instability leading to falls during the ON state - Concomitant therapy or within 28 days prior to baseline with: apomorphine pen injections, alpha-methyl dopa, metoclopramide, reserpine, neuroleptics, methylphenidate, or amphetamine; intrajejunal L-dopa - Previous use of apomorphine pump treatment - History of deep brain stimulation or lesional surgery for PD - Any medical condition that is likely to interfere with an adequate participation in the study, including e.g. current diagnosis of unstable epilepsy; clinically relevant cardiac dysfunction and/or myocardial infarction or stroke within the last 12 months - Symptomatic, clinically relevant and medically uncontrolled orthostatic hypotension - Patients with a borderline QT interval corrected for heart rate according to Bazett's formula (QTc) of >450 ms for male and >470 ms for female at Screening or history of long QT syndrome; or >450 ms absolute duration - Clinically relevant hepatic dysfunction (total bilirubin >2.0 mg/dL, ALT and AST >2 times the upper limit of normal) - Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL); - Pregnant and breastfeeding women - Clinically relevant cognitive decline, defined as MMSE ≤24 or according to DSM IV criteria for dementia - Active psychosis or history of at least moderate psychosis in the past year, or with medically uncontrolled severe depression; very mild illusions or hallucinations in the sense of "feelings of passage or presence" with fully retained insight are not an exclusion criterion - Known history of melanoma - Any investigational therapy in the 4 weeks prior to randomization - History or current drug or alcohol abuse or dependencies

Additional Information

Official title Multicenter,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment
Principal investigator Regina Katzenschlager, Doz. Dr.
Description - Primary efficacy variable is the absolute change in time spent "OFF" from baseline to the end of 12 weeks treatment period based on patient diaries Secondary Endpoints: - Percentage of patients with response to therapy, defined as an OFF time reduction of at least 2 hours, from baseline to end of 12 weeks treatment period - Patient Global Impression of Change - Absolute Change in time spent "ON without troublesome dyskinesia" - Change in oral L-dopa and L-dopa equivalent dose - Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III motor examination) during ON periods - Change in Quality of Life (using PDQ-8)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Britannia Pharmaceuticals Ltd..