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

NCT01683292 | Completed Phase 2

• 1 other identifier: VR040/001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

apomorphine; inhaled; motor fluctuations

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 80 minutes

Secondary Outcomes (1)

• Duration that patients remain in an "on" state.

  until return to "off" up to 3 hours

Study Arms (2)

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.

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.

Drug: Placebo for VR040

Interventions

Inhaled VR040 DRUG

Also known as: Inhaled apomorphine

Inhaled VR040

Placebo for VR040 DRUG

Placebo arm

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• South Glasgow University Hospitals NHS Trust: lead
• Vectura Limited: collaborator

Study Sites (1)

Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neurologist

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: January 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: May 1, 2007
• Last Updated: September 11, 2012

Record last verified: 2012-09

Locations

GB (1)