COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01683292
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : September 11, 2012
Vectura Limited
Information provided by (Responsible Party):
Dr Donald Grosset, South Glasgow University Hospitals NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Inhaled VR040 Drug: Placebo for VR040 Phase 2

Detailed Description:

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's Disease
Study Start Date : January 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Inhaled VR040
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.
Drug: Inhaled VR040
Other Name: Inhaled apomorphine

Placebo Comparator: Placebo
Inhaled dry powder. A single dose, followed by a second dose at 12 minutes if efficacy end point was not attained.
Drug: Placebo for VR040
Placebo arm

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Duration that patients remain in an "on" state. [ Time Frame: until return to "off" up to 3 hours ]
    Time from when patient switched "on" after inhalation of study product, until patient returned to "off" state.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Patients with a modified Hoehn and Yahr disease severity scoring of between 2 and 4 in an "on" state.
  3. Men or women aged over 30 years.
  4. Patients with a signed and dated written valid consent obtained prior to participation.
  5. 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.
  6. 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).
  7. Patient willing and able to comply with study procedures.-

Exclusion Criteria:

  1. Patients who had participated in a trial with an investigational product within 3 months prior to randomisation at Visit 2.
  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.
  3. Patients with previous intolerance to apomorphine.
  4. 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.
  5. Women lactating, pregnant, or of child-bearing potential not using a reliable contraceptive method.
  6. Patients with known HIV or active chronic hepatitis B or C infection.
  7. Patients with any clinically significant abnormality following review of screening laboratory data and full physical examination.
  8. Patients who, in the Investigator's opinion, were unsuitable for the study for any reason.
  9. 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.
  10. Patients with major ECG abnormalities (as judged by the Investigator).
  11. Patients with a FEV1 <65%.
  12. Patients showing a postural decrease in systolic blood pressure (BP) of > 20 mm Hg, or showing significant clinical symptoms associated with orthostatic hypotension.
  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 anabolic steroids, traditional antipsychotics (unless low dose), and antiemetics other than domperidone.
  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.
  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 schizophrenia, dementia, "Parkinson plus" syndromes, or unstable systemic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01683292

Layout table for location information
United Kingdom
Southern General Hospital
Glasgow, United Kingdom, G51 4TF
Sponsors and Collaborators
South Glasgow University Hospitals NHS Trust
Vectura Limited
Layout table for additonal information
Responsible Party: Dr Donald Grosset, Consultant Neurologist, South Glasgow University Hospitals NHS Trust Identifier: NCT01683292    
Other Study ID Numbers: VR040/001
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012
Keywords provided by Dr Donald Grosset, South Glasgow University Hospitals NHS Trust:
motor fluctuations
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action