Parkinson's DiseasePhase 2NCT01683292
Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease
A Phase 2 study testing Inhaled VR040 in people with Parkinson's Disease, run by South Glasgow University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
In this first study of inhaled apomorphine in Parkinson's disease patients, the primary objective is to find the minimum efficacious dose of apomorphine that is useful in rescuing patients during 'off' periods. Safety, tolerability and pharmacokinetics of inhaled apomorphine will be assessed during the study. 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?
- Inhaled VR040
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to May 2007
- 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
- Patients with established idiopathic PD (via fulfilment of Steps 1 and 2 of the UK Brain Bank Criteria), of at least 3 years duration prior to study entry, who were on specific and optimised anti-Parkinson medication (levodopa and/or dopamine agonists), and with motor fluctuations.
- Patients with a modified Hoehn and Yahr disease severity scoring of between 2 and 4 in an "on" state.
- Men or women aged over 30 years.
- Patients with a signed and dated written valid consent obtained prior to participation.
- Female patients must have been of non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who was post-menopausal) or of child-bearing potential with a negative pregnancy test (urine or serum) at screening.
- Patients who experienced motor fluctuations with recognisable "off" periods in control of motor symptoms, as assessed by the motor fluctuation questionnaire (patients were to have reported at least 1 "Yes" response to the questions in the motor fluctuation questionnaire).
- Patient willing and able to comply with study procedures.-
Who cannot join
- Patients who had participated in a trial with an investigational product within 3 months prior to randomisation at Visit 2.
- Patients with serious uncontrolled disease including serious psychological disorders likely to interfere with the study and/or likely to cause death within 6 months of the study completion.
- Patients with previous intolerance to apomorphine.
- Patients with a previous significant complication from oral dopamine agonist therapy including hospitalisation following dopamine agonist introduction and/or the development of hallucinations or other adverse neuropsychiatric features following introduction of sc apomorphine.
- Women lactating, pregnant, or of child-bearing potential not using a reliable contraceptive method.
- Patients with known HIV or active chronic hepatitis B or C infection.
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- Patients with any clinically significant abnormality following review of screening laboratory data and full physical examination.
- Patients who, in the Investigator's opinion, were unsuitable for the study for any reason.
- Patients with clinically significant blood test abnormalities and previous medical history/intercurrent illnesses that may have compromised the safety of the patient in the study.
- Patients with major ECG abnormalities (as judged by the Investigator).
- Patients with a FEV1 <65%.
- Patients showing a postural decrease in systolic blood pressure (BP) of > 20 mm Hg, or showing significant clinical symptoms associated with orthostatic hypotension.
- Patients with persistent elevation of BP, with average systolic readings of 160 mm Hg or average diastolic readings of 100 mm Hg.
- Patients taking anabolic steroids, traditional antipsychotics (unless low dose), and antiemetics other than domperidone.
- Patients taking agents of the 5HT3 antagonist class including ondansetron, granisetron, dolasetron, palonosetron, and alosetron.
- Patients with existing cancer and those in remission for less than 5 years.
- Patients with evidence (as ascertained from examination, tests or history) to indicate cardiovascular, gastrointestinal tract, liver, kidney, central nervous system, pulmonary system, or bone marrow disorders that in the Investigator's opinion compromised patient safety.
- Patients who were known non-responders to apomorphine treatment for "off" episodes.
- Patients with a history of drug or alcohol abuse in the 12 months prior to entry.
- Patients with a history of clinically significant allergies to VR040 formulation constituents (including lactose and opioids) and domperidone.
- Patients with signs or symptoms suggestive of schizophrenia, dementia, "Parkinson plus" syndromes, or unstable systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's Disease
In this first study of inhaled apomorphine in Parkinson's disease patients, the primary objective is to find the minimum efficacious dose of apomorphine that is useful in rescuing patients during 'off' periods. Safety, tolerability and pharmacokinetics of inhaled apomorphine will be assessed during the study.
Read the detailed description
Objectives:
- Conditions
- Parkinson's Disease
- Being tested
- Inhaled VR040, Placebo for VR040
- Keywords
- apomorphine, inhaled, motor fluctuations
- Medical subject headings
- Parkinson Disease, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled VR040Drug
Also called Inhaled apomorphine
Placebo for VR040Drug
Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Inhaled VR040 | Experimental | Inhaled apomorphine, dry powder, VR040 at fine particle doses (FPD) of 0.2mg, 0.5mg and 0.8mg. A single dose, followed by a second dose at 12 minutes if efficacy end point was not attained. Receives: Drug: Inhaled VR040 |
| Placebo | Placebo comparator | Inhaled dry powder. A single dose, followed by a second dose at 12 minutes if efficacy end point was not attained. Receives: Drug: Placebo for VR040 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients "on" at any time post-dosing.
Parkinson's motor severity assessed by a clinician, and disease state assessment by the patient, were performed at baseline during an 'off' state, and at specified times after test drug administration.
Measured: up to 80 minutes
Secondary outcomes (1)
Duration that patients remain in an "on" state.
Time from when patient switched "on" after inhalation of study product, until patient returned to "off" state.
Measured: until return to "off" up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJan 2006
- Primary completionJun 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Glasgow University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Vectura Limited
- Responsible party
- Principal investigator, Dr Donald Grosset, South Glasgow University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683292
- Sponsor's protocol ID
- VR040/001
- Status last verified
- Sep 2012
- First submitted
- 7 Sep 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01683292
- Acronym / sponsor ID
- VR040/001
- Conditions
- Parkinson's Disease
- Keywords
- apomorphine, inhaled, motor fluctuations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- South Glasgow University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Vectura Limited
- Study start
- Jan 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 11 Sep 2012 (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.
In this first study of inhaled apomorphine in Parkinson's disease patients, the primary objective is to find the minimum efficacious dose of apomorphine that is useful in rescuing patients during 'off' periods. Safety, tolerability and pharmacokinetics of inhaled apomorphine will be assessed during the study.
Detailed description
Objectives:
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 |
|---|---|---|
| Inhaled VR040 | Experimental | Drug: Inhaled VR040Inhaled apomorphine, dry powder, VR040 at fine particle doses (FPD) of 0.2mg, 0.5mg and 0.8mg. A single dose, followed by a second dose at 12 minutes if efficacy end point was not attained. |
| Placebo | Placebo comparator | Drug: Placebo for VR040Inhaled dry powder. A single dose, followed by a second dose at 12 minutes if efficacy end point was not attained. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with established idiopathic PD (via fulfilment of Steps 1 and 2 of the UK Brain Bank Criteria), of at least 3 years duration prior to study entry, who were on specific and optimised anti-Parkinson medication (levodopa and/or dopamine agonists), and with motor fluctuations.
- Patients with a modified Hoehn and Yahr disease severity scoring of between 2 and 4 in an "on" state.
- Men or women aged over 30 years.
- Patients with a signed and dated written valid consent obtained prior to participation.
- Female patients must have been of non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who was post-menopausal) or of child-bearing potential with a negative pregnancy test (urine or serum) at screening.
Key exclusion criteria (21 listed)
- Patients who had participated in a trial with an investigational product within 3 months prior to randomisation at Visit 2.
- Patients with serious uncontrolled disease including serious psychological disorders likely to interfere with the study and/or likely to cause death within 6 months of the study completion.
- Patients with previous intolerance to apomorphine.
- Patients with a previous significant complication from oral dopamine agonist therapy including hospitalisation following dopamine agonist introduction and/or the development of hallucinations or other adverse neuropsychiatric features following introduction of sc apomorphine.
- Women lactating, pregnant, or of child-bearing potential not using a reliable contraceptive method.
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 |
|---|---|---|
| Inhaled VR040Also: Inhaled apomorphine | Drug | Inhaled VR040 |
| Placebo for VR040Placebo arm | Drug | Placebo |
Primary outcome
The proportion of patients "on" at any time post-dosing.
Time frame: up to 80 minutes
Parkinson's motor severity assessed by a clinician, and disease state assessment by the patient, were performed at baseline during an 'off' state, and at specified times after test drug administration.
1 secondary outcome
Duration that patients remain in an "on" state.
Time frame: until return to "off" up to 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inhaled VR040 in people with Parkinson's Disease, run by South Glasgow University Hospitals NHS Trust at 1 site in United Kingdom.
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 21 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 11 Sep 2012. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of patients "on" at any time post-dosing. (time frame: up to 80 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.