Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT01683292|
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : September 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Inhaled VR040 Drug: Placebo for VR040||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683292
|Southern General Hospital|
|Glasgow, United Kingdom, G51 4TF|