Parkinson's DiseasePhase 2NCT02702076
Apomorphine in Parkinson's Disease Patients With Visual Hallucinations
A Phase 2 study testing Apomorphine in people with Parkinson's Disease and Hallucinations, Visual, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease, Hallucinations, Visual
- What is being tested?
- Apomorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2017to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Female and male subjects aged ≥30;
- Diagnosis of established PD, defined by the Movement Disorders Society PD criteria (Postuma et al., 2015);
- Presence of visual severe hallucinations defined as more than 3 times a week (van Laar et al., 2010);
- Visual hallucinations must have developed after PD diagnosis;
- Visual hallucinations must have been optimally treated with reduction of dopamine agonists if possible, and prescription of clozapine and/or cholinesterase inhibitors if needed;
- Female subjects must complaint 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, if sexually active;
- Subjects should be able and capable of adhering to the protocol, visit schedules, and medication intake according to the judgement of the investigator.
Who cannot join
- Symptomatic, clinically relevant and medically uncontrolled orthostatic hypotension;
- Patients with a prolonged 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 a long QT syndrome;
- PD medication change (i.e., dopamine-agonists, amantadine, monoamine oxidase (MAO)-B inhibitors, anticholinergics and cholinesterase inhibitors) in last month prior to initiation (van Laar et al., 2010);
- Active psychosis or a history of significant psychosis;
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Department of Neurology
Groningen, 9713GZ
Robbert Borgemeester, MD, +31 (0) 50-3611519, r.w.k.borgemeester@umcg.nl
Robbert Borgemeester, MD
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual Hallucinations
This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.
Read the detailed description
Introduction Visual hallucinations occur frequently in Parkinson's disease (PD). The prevalence of visual hallucinations ranges from 22 to 38%, increasing after long-term follow-up to more than 60%. Risk factors for visual hallucinations are age, disease duration, and cognitive impairment. The treatment of visual hallucinations is cumbersome and options are limited. Only clozapine has been proven to be efficacious without deteriorating the motor symptoms of PD. Instead of oral dopamine agonists and rotigotine, continuous infusion of apomorphine is well-tolerated in PD patients with cognitive impairments and/or visual hallucinations. Even beneficial effect of apomorphine on visual hallucinations are suggested, however there is lack of a randomized controlled trial.
The purpose of this randomised, double-blind, placebo-controlled trial is to evaluate the efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.
- Conditions
- Parkinson's Disease, Hallucinations, Visual
- Being tested
- Apomorphine, Placebo
- Keywords
- Apomorphine
- Medical subject headings
- Parkinson Disease, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApomorphineDrug
Also called APO-go, N04BC07
Continuous subcutaneous infusion of apomorphine during waking day
PlaceboDrug
Continuous subcutaneous infusion of placebo during waking day
| Study group | Role | What they receive |
|---|---|---|
| Apomorphine | Experimental | This arm will be treated with continuous subcutaneous infusion of apomorphine. The infusion will start with 1 mg/hr during the waking day (approximately 16 hours). The flow rate will be adjusted on a weekly basis, and may be increased with 0.5 to 1.0 mg/hr per discretion of the investigator, aiming at the disappearance of visual hallucinations. The duration of treatment is 4 weeks. Receives: Drug: Apomorphine |
| Placebo | Placebo comparator | This arm will be treated with continuous subcutaneous infusion of placebo. The infusion will start with 1 mg/hr during the waking day (approximately 16 hours). The flow rate will be adjusted on a weekly basis, and may be increased with 0.5 to 1.0 mg/hr per discretion of the investigator aiming at the disappearance of visual hallucinations. The duration of treatment is 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression of Severity
Clinical Global Impression of Severity questionnaire
Measured: Four weeks
Secondary outcomes (13)
Clinical Global Impression of Improvement
Clinical Global Impression of Improvement questionnaire
Measured: Four weeks
Cognition
Montreal Cognitive Assessment
Measured: Four weeks
Depression
Hamilton Anxiety and Depression Scale
Measured: Four weeks
Anxiety
Hamilton Anxiety and Depression Scale
Measured: Four weeks
Motor symptoms
Part III of Movement Disorders Society - Unified Parkinson's Disease Rating Scale
Measured: Four weeks
Motor complications
Part IV of Movement Disorders Society - Unified Parkinson's Disease Rating Scale
Measured: Four weeks
Sleeping problems
Parkinson's Disease Sleep Scale
Measured: Four weeks
Neuropsychiatric symptoms
Neuropsychiatric Inventory - Questionnaire
Measured: Four weeks
Visual Hallucinations
Dutch Visual Hallucinations Questionnaire
Measured: Four weeks
Attention
Reaction Time Task
Measured: Four weeks
Visual perception
Visual Object and Space Perception battery
Measured: Four weeks
Apathy
Apathy Scale
Measured: Four weeks
Quality of Life
Parkinson's Disease Questionnaire (shortened version)
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMay 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teus van Laar, University Medical Center Groningen
- Investigators
- Teus van Laar, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702076
- Sponsor's protocol ID
- NL55949
- Status last verified
- May 2017
- First submitted
- 2 Mar 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Laar T, Postma AG, Drent M. Continuous subcutaneous infusion of apomorphine can be used safely in patients with Parkinson's disease and pre-existing visual hallucinations. Parkinsonism Relat Disord. 2010 Jan;16(1):71-2. doi: 10.1016/j.parkreldis.2009.05.006. Epub 2009 Jun 12. No abstract available.
PubMed 19524477Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
PubMed 26474316Fenelon G, Alves G. Epidemiology of psychosis in Parkinson's disease. J Neurol Sci. 2010 Feb 15;289(1-2):12-7. doi: 10.1016/j.jns.2009.08.014. Epub 2009 Sep 8.
PubMed 19740486Goetz CG, Ouyang B, Negron A, Stebbins GT. Hallucinations and sleep disorders in PD: ten-year prospective longitudinal study. Neurology. 2010 Nov 16;75(20):1773-9. doi: 10.1212/WNL.0b013e3181fd6158. Epub 2010 Oct 20.
PubMed 20962287Gallagher DA, Parkkinen L, O'Sullivan SS, Spratt A, Shah A, Davey CC, Bremner FD, Revesz T, Williams DR, Lees AJ, Schrag A. Testing an aetiological model of visual hallucinations in Parkinson's disease. Brain. 2011 Nov;134(Pt 11):3299-309. doi: 10.1093/brain/awr225. Epub 2011 Sep 15.
PubMed 21921019Borgemeester RW, Drent M, van Laar T. Motor and non-motor outcomes of continuous apomorphine infusion in 125 Parkinson's disease patients. Parkinsonism Relat Disord. 2016 Feb;23:17-22. doi: 10.1016/j.parkreldis.2015.11.013. Epub 2015 Nov 22.
PubMed 26709292Garcia Ruiz PJ, Sesar Ignacio A, Ares Pensado B, Castro Garcia A, Alonso Frech F, Alvarez Lopez M, Arbelo Gonzalez J, Baiges Octavio J, Burguera Hernandez JA, Calopa Garriga M, Campos Blanco D, Castano Garcia B, Carballo Cordero M, Chacon Pena J, Espino Ibanez A, Gorospe Onisalde A, Gimenez-Roldan S, Granes Ibanez P, Hernandez Vara J, Ibanez Alonso R, Jimenez Jimenez FJ, Krupinski J, Kulisevsky Bojarsky J, Legarda Ramirez I, Lezcano Garcia E, Martinez-Castrillo JC, Mateo Gonzalez D, Miquel Rodriguez F, Mir P, Munoz Fargas E, Obeso Inchausti J, Olivares Romero J, Olive Plana J, Otermin Vallejo P, Pascual Sedano B, Perez de Colosia Rama V, Perez Lopez-Fraile I, Planas Comes A, Puente Periz V, Rodriguez Oroz MC, Sevillano Garcia D, Solis Perez P, Suarez Munoz J, Vaamonde Gamo J, Valero Merino C, Valldeoriola Serra F, Velazquez Perez JM, Yanez Bana R, Zamarbide Capdepon I. Efficacy of long-term continuous subcutaneous apomorphine infusion in advanced Parkinson's disease with motor fluctuations: a multicenter study. Mov Disord. 2008 Jun 15;23(8):1130-6. doi: 10.1002/mds.22063.
PubMed 18442107Martinez-Martin P, Reddy P, Antonini A, Henriksen T, Katzenschlager R, Odin P, Todorova A, Naidu Y, Tluk S, Chandiramani C, Martin A, Chaudhuri KR. Chronic subcutaneous infusion therapy with apomorphine in advanced Parkinson's disease compared to conventional therapy: a real life study of non motor effect. J Parkinsons Dis. 2011;1(2):197-203. doi: 10.3233/JPD-2011-11037.
PubMed 23934921Martinez-Martin P, Reddy P, Katzenschlager R, Antonini A, Todorova A, Odin P, Henriksen T, Martin A, Calandrella D, Rizos A, Bryndum N, Glad A, Dafsari HS, Timmermann L, Ebersbach G, Kramberger MG, Samuel M, Wenzel K, Tomantschger V, Storch A, Reichmann H, Pirtosek Z, Trost M, Svenningsson P, Palhagen S, Volkmann J, Chaudhuri KR. EuroInf: a multicenter comparative observational study of apomorphine and levodopa infusion in Parkinson's disease. Mov Disord. 2015 Apr;30(4):510-6. doi: 10.1002/mds.26067. Epub 2014 Nov 10.
PubMed 25382161Ellis C, Lemmens G, Parkes JD, Abbott RJ, Pye IF, Leigh PN, Chaudhuri KR. Use of apomorphine in parkinsonian patients with neuropsychiatric complications to oral treatment. Parkinsonism Relat Disord. 1997 Apr;3(2):103-7. doi: 10.1016/s1353-8020(97)00009-6.
PubMed 18591063
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual Hallucinations
- ClinicalTrials.gov ID
- NCT02702076
- Acronym / sponsor ID
- NL55949
- Conditions
- Parkinson's Disease, Hallucinations, Visual
- Keywords
- Apomorphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.
Detailed description
Introduction Visual hallucinations occur frequently in Parkinson's disease (PD). The prevalence of visual hallucinations ranges from 22 to 38%, increasing after long-term follow-up to more than 60%. Risk factors for visual hallucinations are age, disease duration, and cognitive impairment. The treatment of visual hallucinations is cumbersome and options are limited. Only clozapine has been proven to be efficacious without deteriorating the motor symptoms of PD. Instead of oral dopamine agonists and rotigotine, continuous infusion of apomorphine is well-tolerated in PD patients with cognitive impairments and/or visual hallucinations. Even beneficial effect of apomorphine on visual hallucinations are suggested, however there is lack of a randomized controlled trial.
The purpose of this randomised, double-blind, placebo-controlled trial is to evaluate the efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apomorphine | Experimental | Drug: ApomorphineThis arm will be treated with continuous subcutaneous infusion of apomorphine. The infusion will start with 1 mg/hr during the waking day (approximately 16 hours). The flow rate will be adjusted on a weekly basis, and may be increased with 0.5 to 1.0 mg/hr per discretion of the investigator, aiming at the disappearance of visual hallucinations. The duration of treatment is 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboThis arm will be treated with continuous subcutaneous infusion of placebo. The infusion will start with 1 mg/hr during the waking day (approximately 16 hours). The flow rate will be adjusted on a weekly basis, and may be increased with 0.5 to 1.0 mg/hr per discretion of the investigator aiming at the disappearance of visual hallucinations. The duration of treatment is 4 weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female and male subjects aged ≥30;
- Diagnosis of established PD, defined by the Movement Disorders Society PD criteria (Postuma et al., 2015);
- Presence of visual severe hallucinations defined as more than 3 times a week (van Laar et al., 2010);
- Visual hallucinations must have developed after PD diagnosis;
- Visual hallucinations must have been optimally treated with reduction of dopamine agonists if possible, and prescription of clozapine and/or cholinesterase inhibitors if needed;
Key exclusion criteria (5 listed)
- Symptomatic, clinically relevant and medically uncontrolled orthostatic hypotension;
- Patients with a prolonged 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 a long QT syndrome;
- PD medication change (i.e., dopamine-agonists, amantadine, monoamine oxidase (MAO)-B inhibitors, anticholinergics and cholinesterase inhibitors) in last month prior to initiation (van Laar et al., 2010);
- Active psychosis or a history of significant psychosis;
- 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.
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 |
|---|---|---|
| ApomorphineAlso: APO-go, N04BC07Continuous subcutaneous infusion of apomorphine during waking day | Drug | Apomorphine |
| PlaceboContinuous subcutaneous infusion of placebo during waking day | Drug | Placebo |
Primary outcome
Clinical Global Impression of Severity
Time frame: Four weeks
Clinical Global Impression of Severity questionnaire
13 secondary outcomes
Clinical Global Impression of Improvement
Time frame: Four weeks
Cognition
Time frame: Four weeks
Depression
Time frame: Four weeks
Anxiety
Time frame: Four weeks
Motor symptoms
Time frame: Four weeks
Motor complications
Time frame: Four weeks
Sleeping problems
Time frame: Four weeks
Neuropsychiatric symptoms
Time frame: Four weeks
Visual Hallucinations
Time frame: Four weeks
Attention
Time frame: Four weeks
Visual perception
Time frame: Four weeks
Apathy
Time frame: Four weeks
Quality of Life
Time frame: Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Results publication: PubMed 19524477van Laar T, Postma AG, Drent M. Continuous subcutaneous infusion of apomorphine can be used safely in patients with Parkinson's disease and pre-existing visual hallucinations. Parkinsonism Relat Disord. 2010 Jan;16(1):71-2. doi: 10.1016/j.parkreldis.2009.05.006. Epub 2009 Jun 12. No abstract available.
- Results publication: PubMed 26474316Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
- Results publication: PubMed 19740486Fenelon G, Alves G. Epidemiology of psychosis in Parkinson's disease. J Neurol Sci. 2010 Feb 15;289(1-2):12-7. doi: 10.1016/j.jns.2009.08.014. Epub 2009 Sep 8.
- Results publication: PubMed 20962287Goetz CG, Ouyang B, Negron A, Stebbins GT. Hallucinations and sleep disorders in PD: ten-year prospective longitudinal study. Neurology. 2010 Nov 16;75(20):1773-9. doi: 10.1212/WNL.0b013e3181fd6158. Epub 2010 Oct 20.
- Results publication: PubMed 21921019Gallagher DA, Parkkinen L, O'Sullivan SS, Spratt A, Shah A, Davey CC, Bremner FD, Revesz T, Williams DR, Lees AJ, Schrag A. Testing an aetiological model of visual hallucinations in Parkinson's disease. Brain. 2011 Nov;134(Pt 11):3299-309. doi: 10.1093/brain/awr225. Epub 2011 Sep 15.
- Results publication: PubMed 26709292Borgemeester RW, Drent M, van Laar T. Motor and non-motor outcomes of continuous apomorphine infusion in 125 Parkinson's disease patients. Parkinsonism Relat Disord. 2016 Feb;23:17-22. doi: 10.1016/j.parkreldis.2015.11.013. Epub 2015 Nov 22.
- Results publication: PubMed 18442107Garcia Ruiz PJ, Sesar Ignacio A, Ares Pensado B, Castro Garcia A, Alonso Frech F, Alvarez Lopez M, Arbelo Gonzalez J, Baiges Octavio J, Burguera Hernandez JA, Calopa Garriga M, Campos Blanco D, Castano Garcia B, Carballo Cordero M, Chacon Pena J, Espino Ibanez A, Gorospe Onisalde A, Gimenez-Roldan S, Granes Ibanez P, Hernandez Vara J, Ibanez Alonso R, Jimenez Jimenez FJ, Krupinski J, Kulisevsky Bojarsky J, Legarda Ramirez I, Lezcano Garcia E, Martinez-Castrillo JC, Mateo Gonzalez D, Miquel Rodriguez F, Mir P, Munoz Fargas E, Obeso Inchausti J, Olivares Romero J, Olive Plana J, Otermin Vallejo P, Pascual Sedano B, Perez de Colosia Rama V, Perez Lopez-Fraile I, Planas Comes A, Puente Periz V, Rodriguez Oroz MC, Sevillano Garcia D, Solis Perez P, Suarez Munoz J, Vaamonde Gamo J, Valero Merino C, Valldeoriola Serra F, Velazquez Perez JM, Yanez Bana R, Zamarbide Capdepon I. Efficacy of long-term continuous subcutaneous apomorphine infusion in advanced Parkinson's disease with motor fluctuations: a multicenter study. Mov Disord. 2008 Jun 15;23(8):1130-6. doi: 10.1002/mds.22063.
- Results publication: PubMed 23934921Martinez-Martin P, Reddy P, Antonini A, Henriksen T, Katzenschlager R, Odin P, Todorova A, Naidu Y, Tluk S, Chandiramani C, Martin A, Chaudhuri KR. Chronic subcutaneous infusion therapy with apomorphine in advanced Parkinson's disease compared to conventional therapy: a real life study of non motor effect. J Parkinsons Dis. 2011;1(2):197-203. doi: 10.3233/JPD-2011-11037.
- Results publication: PubMed 25382161Martinez-Martin P, Reddy P, Katzenschlager R, Antonini A, Todorova A, Odin P, Henriksen T, Martin A, Calandrella D, Rizos A, Bryndum N, Glad A, Dafsari HS, Timmermann L, Ebersbach G, Kramberger MG, Samuel M, Wenzel K, Tomantschger V, Storch A, Reichmann H, Pirtosek Z, Trost M, Svenningsson P, Palhagen S, Volkmann J, Chaudhuri KR. EuroInf: a multicenter comparative observational study of apomorphine and levodopa infusion in Parkinson's disease. Mov Disord. 2015 Apr;30(4):510-6. doi: 10.1002/mds.26067. Epub 2014 Nov 10.
- Results publication: PubMed 18591063Ellis C, Lemmens G, Parkes JD, Abbott RJ, Pye IF, Leigh PN, Chaudhuri KR. Use of apomorphine in parkinsonian patients with neuropsychiatric complications to oral treatment. Parkinsonism Relat Disord. 1997 Apr;3(2):103-7. doi: 10.1016/s1353-8020(97)00009-6.
- 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.
Teus van Laar, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apomorphine in people with Parkinson's Disease and Hallucinations, Visual, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robbert Borgemeester, MD (+31 50 3611519, r.w.k.borgemeester@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression of Severity (time frame: Four 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 NCT02702076, which also lists 10 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 3 May 2017.