Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease
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|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.
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 ClinicalTrials.gov identifier (NCT number): NCT01683292
|Southern General Hospital|
|Glasgow, United Kingdom, G51 4TF|