Parkinson's DiseaseNCT00245700
Adherence of Stalevo, Entacapone and Levodopa
An observational study of Parkinson's Disease, run by South Glasgow University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
To test if combining two antiparkinson drugs into a single tablet improves accuracy of medicine intake by the patient. To test if patients with Parkinson's disease who take medicines at regular time intervals have smoother symptom control. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to Jul 2006
- Phase
- Observational
- 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
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Parkinson's disease aged between 18 and 85 years fulfilling UK Brain Bank criteria.
- Current levodopa therapy prescribed on a regular basis three or more times per day but requiring entacapone because of 'wearing off'
- Able to manipulate electronic monitoring bottles and complete questionnaires
Who cannot join
- Current use of compliance aid such that study participation would be detrimental to patient's adherence
- Pregnancy or breast feeding
- Excess alcohol (over 21 units per week for women and 28 units for men)
- Mini mental state examination of less than 26.
- Severe depression (Geriatric depression score over 20)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southern General Hospital
Glasgow, Scotland, G51 4TF
About this study
Official title: Study of Adherence of Stalevo, Entacapone and Levodopa
To test if combining two antiparkinson drugs into a single tablet improves accuracy of medicine intake by the patient.
To test if patients with Parkinson's disease who take medicines at regular time intervals have smoother symptom control.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startApr 2005
- Study completionJul 2006
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
- Observational
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- South Glasgow University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Donald G Grosset, MBChB, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245700
- Sponsor's protocol ID
- R050017
- Other IDs
- Grant from Orion Pharma
- Status last verified
- May 2008
- First submitted
- 27 Oct 2005
- Last updated
- 23 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Adherence of Stalevo, Entacapone and Levodopa
- ClinicalTrials.gov ID
- NCT00245700
- Acronym / sponsor ID
- R050017
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- South Glasgow University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 28 Oct 2005 (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 test if combining two antiparkinson drugs into a single tablet improves accuracy of medicine intake by the patient.
To test if patients with Parkinson's disease who take medicines at regular time intervals have smoother symptom control.
Study design
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with Parkinson's disease aged between 18 and 85 years fulfilling UK Brain Bank criteria.
- Current levodopa therapy prescribed on a regular basis three or more times per day but requiring entacapone because of 'wearing off'
- Able to manipulate electronic monitoring bottles and complete questionnaires
Key exclusion criteria (5 listed)
- Current use of compliance aid such that study participation would be detrimental to patient's adherence
- Pregnancy or breast feeding
- Excess alcohol (over 21 units per week for women and 28 units for men)
- Mini mental state examination of less than 26.
- Severe depression (Geriatric depression score over 20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 23 May 2008.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Donald G Grosset, MBChB, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by South Glasgow University Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 5 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 23 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 23 May 2008.