Phase IIa Multicentre Study Investigating of VR040 in Parkinson's Disease

NCT01693081 | Completed Phase 2 DMC

• 1 other identifier: VR040/2/003
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 9

Brief Summary

'Off periods' where people with Parkinson's disease are slow, stiff and unable to function are disabling, and a treatment which can converts people to a "on", good, able to function state would be extremely useful. We assessed safety, tolerability and efficacy of inhaled dry powder apomorphine (VR040) in a clinic-based study in this setting.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; inhaled apomorphine; convert "off" to "on"

Outcome Measures

Primary Outcomes (1)

• The maximum UPDRS 3 improvement from pre-dose to post-dose

  The primary efficacy endpoint was the maximum UPDRS 3 improvement from pre-dose to post-dose at the highest dose used.

  90 minutes

Secondary Outcomes (3)

• Time to improvement from 'off' to 'on'

  90 minutes

• The duration of 'on'

  90 minutes

• The proportion of patients converting to 'on' any time after treatment administration.

  90 minutes

Other Outcomes (1)

• Safety variables

  90minutes

Study Arms (2)

VR040/Aspirair® inhaler

ACTIVE COMPARATOR

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.

Drug: VR040/Aspirair® inhaler

Placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

VR040/Aspirair® inhaler DRUG

Dry Powder inhaled apomorphine

Also known as: Inhaled apomorphine

VR040/Aspirair® inhaler

placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 30 and 90 years old with idiopathic PD for at least 5 years.
• Voluntary written informed consent provided.
• Willing and able to comply with study procedures.
• Fulfilled steps 1 and 2 of the UK Brain Bank Criteria.
• Classified as Hoehn and Yahr Stage II to IV in "on" state.
• Motor fluctuations with recognisable "off" periods in control of motor symptoms, as assessed by the Motor Fluctuation Questionnaire.
• Optimised oral therapy.
• Dopaminergic responsiveness as defined by ≥ 30% improvement(reduction) in UPDRS III score compared with pre-dose value.

You may not qualify if:

• Participated in a trial with an investigational product within prior 3 months.
• Serious uncontrolled disease including serious psychological disorders.
• Previous intolerance to apomorphine.
• Previous significant complication from oral dopamine agonist therapy
• Women lactating, pregnant or of child-bearing potential not using a reliable contraceptive method (eg, barrier, intrauterine device, abstinence).
• Known HIV or active chronic hepatitis B or C infection.
• Any clinically significant abnormality following review of screening observations
• Patients who, in the Investigator's opinion, were unsuitable for the study for any reason.
• Major ECG abnormalities.
• Patients with a FEV1 ≤ 65% predicted.
• 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 arterial hypotension, with average systolic readings of ≤110 mm Hg.
• Patients with persistent elevation of BP, with average systolic readings of ≥160 mm Hg.
• or average diastolic readings of ≥100 mm Hg.
• 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).

Sponsors & Collaborators

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

Study Sites (9)

Neurology Clinical Military Medical Academy, Crnotravska 17

Belgrade, 11 000, Serbia

Location

Institute of Neurology Clinical Center Serbia Dr Subotica 6

Belgrade, 11000, Serbia

Location

University Hospital, Wales

Cardiff, CF14 4XW, United Kingdom

Location

Department of Neurology, Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

The Walton Centre

Liverpool, L9 7LJ, United Kingdom

Location

Llandudno Hospital

Llandudno, LL30 1LB, United Kingdom

Location

Newark Hospital

Newark, NG24 4DE, United Kingdom

Location

Neurology Dept, Radcliffe Infirmary

Oxford, OX2 6HE, United Kingdom

Location

Essex Neurosciences, UnitOld Church Hospital, Essex

Romford Essex, RM7 0BE, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Donald Grosset, MD

  South Glasgow NHS Hospitals

  PRINCIPAL INVESTIGATOR

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 21, 2012
• First Posted: September 26, 2012
• Study Start: March 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2009
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

GB (7); SE (2)