Parkinson's DiseasePhase 2/3NCT00346827
Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.
A Phase 2/3 study testing Apomorphine Nasal Powder in people with Parkinson's Disease, run by Britannia Pharmaceuticals Ltd..
Trial summary
To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Apomorphine Nasal Powder
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Aug 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented "off" period per day
Who cannot join
- hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females
About this study
To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.
- Conditions
- Parkinson's Disease
- Being tested
- Apomorphine Nasal Powder
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apomorphine Nasal PowderDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- 3-week, double-blind, placebo-controlled, 3 × crossover efficacy phase followed by 12 week open label phase, followed by 36 week open continuation phase
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Britannia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Weiser, MB, MRCP, Principal investigator, Swansea Hospital, Swansea, Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346827
- Sponsor's protocol ID
- 20102D05
- Status last verified
- Jul 2019
- First submitted
- 29 Jun 2006
- Last updated
- 10 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.
- ClinicalTrials.gov ID
- NCT00346827
- Acronym / sponsor ID
- 20102D05
- Conditions
- Parkinson's Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Britannia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2006 (actual)
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Model description
- 3-week, double-blind, placebo-controlled, 3 × crossover efficacy phase followed by 12 week open label phase, followed by 36 week open continuation phase
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented "off" period per day
Key exclusion criteria (1 listed)
- hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apomorphine Nasal Powder | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Weiser, MB, MRCP principal investigator
Swansea Hospital, Swansea, Wales
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Apomorphine Nasal Powder in people with Parkinson's Disease, run by Britannia Pharmaceuticals Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.