Parkinson's DiseasePhase 3TOLEDONCT02006121
Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease
A Phase 3 study testing Apomorphine hydrochloride in people with Parkinson's Disease, run by Britannia Pharmaceuticals Ltd. at 20 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Apomorphine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 3 Mar 2014to 8 Jun 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 < 2 hours of OFF time recorded
- Stable medication regimen, with a stable dose of levodopa administered in at least 4 intakes, for at least 28 days prior to baseline. All oral or transdermal antiparkinsonian drugs were permitted, with the exception of budipine. This regimen might include the use of levodopa/DDCI rescue medication, if this occurred up to 2 times a day, at doses of up to 200 mg levodopa/day
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- 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 the 12-month OLP, if sexually active
- Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) or urine 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
Who cannot join
- History of respiratory depression
- Hypersensitivity to apomorphine or any excipients of the medicinal product
- 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 levodopa
- Previous use of apomorphine pump treatment
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- 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 (QTcB) of >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
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Germany4 sites
Neurologisches Fachkrankenhausfür Bewegungsstörungen / Parkinson
Beelitz-Heilstätten
Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik
Bremerhaven
Paracelsus Elena-Klinik Kassel
Kassel
Schön Klinik München Schwabing / Neurologie und Klinische Neurophysiologie
München
United Kingdom4 sites
The Walton Centre Nhs Foundation Trust
Liverpool
Kings College Hospital NHS Foundation Trust
London
St George's Heathcare NHS Trust
London
Newcastle University, Clinical Ageing Research Unit (CARU)
Newcastle
Austria3 sites
Medizinische Universität Graz / Univ. Klinik für Neurologie
Graz
Medizinische Universität Innsbruck
Innsbruck
Donauspital / SMZ-Ost, Abteilung für Neurologie, Sekretariat (Stock 1, Ebene 4)
Vienna, 1220
France3 sites
CHRU Clermont- Ferrand Gabriel-Montpied
Clermont-Ferrand
CHU de Rennes, Hôpital Pontchaillou
Rennes
CHU Toulouse, Hôpital Purpan, Centre d'Investigation Clinique
Toulouse
Netherlands3 sites
Universitair Medisch Centrum
Groningen
Atrium MC parkstad
Heerlen
Erasmus MC
Rotterdam
Spain2 sites
Hospital Clínic de Barcelona
Barcelona
Hospital Universitario Fundación Jiménez Díaz
Madrid
Denmark1 site
Bispebjerg University Hospital, Movement Disorder Centre
Copenhagen
About this study
Official title: Multicentre,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
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.
Read the detailed description
The primary efficacy variable is the mean change in time spent "OFF" from baseline (start of blinded treatment) to the end of a 12 weeks' double-blind treatment period based on patient diaries. Patients recorded their motor symptoms in half-hour blocks as OFF, ON without dyskinesia, ON without troublesome dyskinesia, or sleeping using the Hauser Parkinson's Disease home diary.
Key secondary Endpoints (tested hierarchically):
- Change in time spent "ON without troublesome dyskinesia"
- Patient Global Impression of Change
Other Endpoints:
- Percentage of patients with response to therapy, defined as a mean OFF time reduction of at least 2 hours
- Change in oral levodopa and levodopa equivalent dose
- Conditions
- Parkinson's Disease
- Being tested
- Apomorphine hydrochloride, Placebo
- Keywords
- Parkinson's disease, motor fluctuations, not well controlled, medical treatment, apomorphine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apomorphine hydrochlorideDrug
Also called Apo-go
Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe
PlaceboDrug
Sodium chloride 9 mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Apomorphine hydrochloride | Active comparator | Apo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe Receives: Drug: Apomorphine hydrochloride |
| Placebo | Placebo comparator | Placebo: saline infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
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
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.
Measured: Baseline and 12 weeks
Patient Global Impression of Change (PGIC), Using the mITT Population
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.
Measured: Baseline and 12 weeks
Mean Change in Oral Levodopa Dose From Baseline to Visit 10 Using MMRM for the mITT Population
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.
Measured: Baseline and 12 weeks
Mean Change in Levodopa Equivalent Dose From Baseline to Visit 10 (Week 12) Using MMRM in the mITT Population
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study start3 Mar 2014
- Primary completion6 Jun 2016
- Study completion8 Jun 2017
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Britannia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Regina Katzenschlager, Doz. Dr., Principal investigator, Donauspital KH SMZ Ost, Neurologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006121
- Sponsor's protocol ID
- CT-37527-13-0124
- Other IDs
- 2013-000980-10
- Acronym
- TOLEDO
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2013
- Last updated
- 8 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Lockhart D, Staines H, Lees A. 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. Parkinsonism Relat Disord. 2021 Feb;83:79-85. doi: 10.1016/j.parkreldis.2020.12.024. Epub 2021 Jan 12.
PubMed 33486139Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Spivey K, Vel S, Staines H, Lees A. Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2018 Sep;17(9):749-759. doi: 10.1016/S1474-4422(18)30239-4. Epub 2018 Jul 25.
PubMed 30055903
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre,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
- ClinicalTrials.gov ID
- NCT02006121
- Acronym / sponsor ID
- TOLEDO / CT-37527-13-0124
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, motor fluctuations, not well controlled, medical treatment, apomorphine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Britannia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2014 (actual)
- Primary completion
- 6 Jun 2016 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 8 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary efficacy variable is the mean change in time spent "OFF" from baseline (start of blinded treatment) to the end of a 12 weeks' double-blind treatment period based on patient diaries. Patients recorded their motor symptoms in half-hour blocks as OFF, ON without dyskinesia, ON without troublesome dyskinesia, or sleeping using the Hauser Parkinson's Disease home diary.
Key secondary Endpoints (tested hierarchically):
- Change in time spent "ON without troublesome dyskinesia"
- Patient Global Impression of Change
Other Endpoints:
- Percentage of patients with response to therapy, defined as a mean OFF time reduction of at least 2 hours
- Change in oral levodopa and levodopa equivalent dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apomorphine hydrochloride | Active comparator | Drug: Apomorphine hydrochlorideApo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: saline infusion |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 < 2 hours of OFF time recorded
Key exclusion criteria (18 listed)
- History of respiratory depression
- Hypersensitivity to apomorphine or any excipients of the medicinal product
- 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 levodopa
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 |
|---|---|---|
| Apomorphine hydrochlorideAlso: Apo-goApomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe | Drug | Apomorphine hydrochloride |
| PlaceboSodium chloride 9 mg/ml | Drug | Placebo |
Primary outcome
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
Time frame: 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.
4 secondary outcomes
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
Time frame: Baseline and 12 weeks
Patient Global Impression of Change (PGIC), Using the mITT Population
Time frame: Baseline and 12 weeks
Mean Change in Oral Levodopa Dose From Baseline to Visit 10 Using MMRM for the mITT Population
Time frame: Baseline and 12 weeks
Mean Change in Levodopa Equivalent Dose From Baseline to Visit 10 (Week 12) Using MMRM in the mITT Population
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33486139Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Lockhart D, Staines H, Lees A. 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. Parkinsonism Relat Disord. 2021 Feb;83:79-85. doi: 10.1016/j.parkreldis.2020.12.024. Epub 2021 Jan 12.
- Derived from this study: PubMed 30055903Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Spivey K, Vel S, Staines H, Lees A. Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2018 Sep;17(9):749-759. doi: 10.1016/S1474-4422(18)30239-4. Epub 2018 Jul 25.
- Individual participant dataSharing planned: No
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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.
Regina Katzenschlager, Doz. Dr. principal investigator
Donauspital KH SMZ Ost, Neurologie
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apomorphine hydrochloride in people with Parkinson's Disease, run by Britannia Pharmaceuticals Ltd. at 20 sites in 7 countries.
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 12 inclusion and 18 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 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, United Kingdom, Austria, France, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Jul 2019). 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?
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 (time frame: Baseline and 12 weeks). 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 NCT02006121, which also lists 2 linked publications.
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 8 Jul 2019.