Phase IIa Multicentre Study Investigating of VR040 in Parkinson's Disease
NCT ID: NCT01693081
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2007-03-31
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Methods: We assessed safety, tolerability and efficacy of inhaled dry powder apomorphine (VR040) in a clinic-based Phase II study. Of 48 patients recruited at 9 sites, 47 were randomized 2:1 inhaled apomorphine:placebo. Respirable doses (drug predicted to reach the lung) ascending through 1.5mg, 2.3mg, 3.0mg, and 4.0mg until efficacy was achieved, were administered to patients in a practically defined 'off' state. The primary endpoint was the response in unified Parkinson's disease rating scale Part 3 (UPDRS 3), at the highest dose received by the patient. Secondary endpoints included time to 'on', the proportion of patients converting from 'off' to 'on', and pharmacokinetics.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VR040/Aspirair® inhaler
VR040 was administered as an inhaled dry powder, in a dosage of 1.5, 2.3, 3.0 and 4.0mg, single dose given at each dose level.
VR040/Aspirair® inhaler
Dry Powder inhaled apomorphine
Placebo
Placebo was administered as an inhaled dry powder, matching to active comparator at dosages of 1.5, 2.3, 3.0 and 4.0mg, single dose given at each dose level.
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VR040/Aspirair® inhaler
Dry Powder inhaled apomorphine
placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Voluntary written informed consent provided.
3. Willing and able to comply with study procedures.
4. Fulfilled steps 1 and 2 of the UK Brain Bank Criteria.
5. Classified as Hoehn and Yahr Stage II to IV in "on" state.
6. Motor fluctuations with recognisable "off" periods in control of motor symptoms, as assessed by the Motor Fluctuation Questionnaire.
7. Optimised oral therapy.
8. Dopaminergic responsiveness as defined by ≥ 30% improvement(reduction) in UPDRS III score compared with pre-dose value.
Exclusion Criteria
2. Serious uncontrolled disease including serious psychological disorders.
3. Previous intolerance to apomorphine.
4. Previous significant complication from oral dopamine agonist therapy
5. Women lactating, pregnant or of child-bearing potential not using a reliable contraceptive method (eg, barrier, intrauterine device, abstinence).
6. Known HIV or active chronic hepatitis B or C infection.
7. Any clinically significant abnormality following review of screening observations
8. Patients who, in the Investigator's opinion, were unsuitable for the study for any reason.
9. Major ECG abnormalities.
10. Patients with a FEV1 ≤ 65% predicted.
11. Patients showing a postural decrease in systolic blood pressure (BP) of ≥20 mm Hg or showing significant clinical symptoms associated with orthostatic hypotension.
12. Patients with persistent arterial hypotension, with average systolic readings of ≤110 mm Hg.
13. Patients with persistent elevation of BP, with average systolic readings of ≥160 mm Hg.
or average diastolic readings of ≥100 mm Hg.
14. Patients taking apomorphine at any time during these study visits, anabolic steroids,traditional antipsychotics (unless low dose) and vasodilators other than for the treatment of hypertension. The following atypical antipsychotics were permitted: Quetiapine (up to and including 50 mg per day), risperidone (up to and including 1 mg per day) and olanzapine (up to and including 2.5 mg per day).
15. Patients taking agents of the 5HT3 antagonist class including ondansetron, granisetron,dolasetron, palonosetron and alosetron.
16. Patients with existing cancer and those in remission for less than 5 years.
17. 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.
18. Patients who were known non-responders to apomorphine treatment for "off" episodes(eg, in previous challenge tests or trials).
19. Patients with a history of drug or alcohol abuse in the 12 months prior to entry.
20. Patients with a history of clinically significant allergies to VR040 formulation constituents (including lactose and opioids) and domperidone.
21. Patients with signs or symptoms suggestive of psychosis, dementia, "Parkinson-plus" syndromes or unstable systemic disease.
22. Patients with history of stroke, seizure or other neurological conditions.
23. Patients with dyskinesia rated 4 in Item 32 of UPDRS IV assessment at Screening(dyskinesia present ≥76% of a waking day).
30 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vectura Limited
INDUSTRY
South Glasgow University Hospitals NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Donald Grosset
Consultant Neurologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Donald Grosset, MD
Role: PRINCIPAL_INVESTIGATOR
South Glasgow NHS Hospitals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurology Clinical Military Medical Academy, Crnotravska 17
Belgrade, , Serbia
Institute of Neurology Clinical Center Serbia Dr Subotica 6
Belgrade, , Serbia
University Hospital, Wales
Cardiff, , United Kingdom
Department of Neurology, Southern General Hospital
Glasgow, , United Kingdom
The Walton Centre
Liverpool, , United Kingdom
Llandudno Hospital
Llandudno, , United Kingdom
Newark Hospital
Newark, , United Kingdom
Neurology Dept, Radcliffe Infirmary
Oxford, , United Kingdom
Essex Neurosciences, UnitOld Church Hospital, Essex
Romford Essex, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VR040/2/003
Identifier Type: -
Identifier Source: org_study_id