Phase 3
Completed N=107
Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease
Source: ClinicalTrials.gov NCT02006121 ↗Enrolled (actual)
107
Serious AEs
16.6%
Results posted
Jul 2019
Primary outcomePrimary: 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 — -2.61; -0.75 Hours — p=0.0047
◆ Published Evidence
Highly cited
313citations · ~39 / year
Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial.
Summary
The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment.
The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.
Linked Publications (2)
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Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial.
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Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-2.61; -0.75 | 0.0047 sig |
| 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 |
2.90; 0.85 | 0.0022 sig |
| SECONDARY Patient Global Impression of Change (PGIC), Using the mITT Population |
79.1; 23.5 | <0.0001 sig |
| SECONDARY Mean Change in Oral Levodopa Dose From Baseline to Visit 10 Using MMRM for the mITT Population |
-242.09; -76.46 | 0.005 sig |
| SECONDARY Mean Change in Levodopa Equivalent Dose From Baseline to Visit 10 (Week 12) Using MMRM in the mITT Population |
-502.02; -150.87 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged ≥30 years
- Diagnosis of idiopathic PD 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 levodopa which was judged by the treating physician to be optimal
- Average of OFF time > 3 hours/day based on screening and baseline diary entries with no day with 450 msec for male and >470 msec for female at screening or history of long QT syndrome; or >450 msec absolute duration
- Clinically relevant hepatic dysfunction (total bilirubin >2.0 mg/dL, alanine transaminase [ALT] and aspartate transaminase [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 Diagnostic and Statistical Manual of Mental Disorders (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
Data sourced from ClinicalTrials.gov (NCT02006121) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.