Parkinson DiseasePhase 4TANDEM-662NCT01485172
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
A Phase 4 study testing ropinirole monotherapy in people with Parkinson Disease, run by GlaxoSmithKline at 34 sites in 5 countries.
Trial summary
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn \& Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ropinirole monotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 34 sitesin 5 countries
- Study dates
- 31 Jan 2012to 30 Apr 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease (according to modified Hoehn \& Yahr criteria Stages I-III.)
- Subjects aged 30 years or greater at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for at least one month prior to randomization and one month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, surgical sterilisation, male partner sterilization, intrauterine device [IUD], or double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository.
- A baseline UPDRS motor score of at least 10.
- Limited prior exposure to low or moderate doses of L-DOPA (up to 3 months in total) or dopamine agonists including ropinirole (up to 6 months in total) is allowed provided treatment is discontinued for a minimum of 4 weeks prior to screening.
- Provide written informed consent for this study.
- Be willing and able to comply with study procedures.
Who cannot join
- Subjects with Parkinson's disease in whom dopaminergic therapy is not warranted at the time of screening.
- Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, render the subject unsuitable for the study (e.g., psychiatric, haematological, renal, hepatic, endocrinology, neurological [other than Parkinson's disease], cardiovascular, or active malignancy [other than basal cell carcinoma]).
- Subjects with crippling degenerative arthritis or other physical or mental conditions precluding accurate assessment of efficacy or safety.
- Subjects with prior or current major psychosis (e.g., schizophrenia or psychotic depression) e.g. scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
- Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1 [mentation].
- Subjects with severe dizziness or fainting due to postural hypotension on standing.
Show all 16Show fewer
- Subjects with a personal history of melanoma.
- Subjects with clinically significant abnormalities in laboratory or ECG tests at Screening. If findings are outside the normal range and the subject is included, it must be documented by the investigator that the findings are not of clinical significance.
- Subjects diagnosed with an impulse control disorder. The modified MIDI will be conducted at screening. Subjects who score positive for this screen must be referred to a specialist for diagnostic evaluation prior to enrolling (screening) in the study.
- Subjects with an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Subjects with a history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
- Current alcohol or drug dependence.
- Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole.
- Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to baseline (randomization).
- Subjects on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to baseline (randomization) through the end of the treatment period. Smokers should maintain normal smoking habit.
- Women who are pregnant or breast-feeding.
- Use of an investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) to the end of the treatment period.
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
Russia12 sites
GSK Investigational Site
Chelyabinsk, 454136
GSK Investigational Site
Kazan', 420012
GSK Investigational Site
Krasnoyarsk, 660022
GSK Investigational Site
Kursk, 305007
GSK Investigational Site
Novosibirsk, 630091
GSK Investigational Site
Omsk, 644033
GSK Investigational Site
Perm, 614990
GSK Investigational Site
Saint Petersburg, 194044
GSK Investigational Site
Saratov, 410012
GSK Investigational Site
Smolensk, 214019
GSK Investigational Site
Ufa, 450000
GSK Investigational Site
Yekaterinburg, 620102
United States11 sites
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Boca Raton, Florida, 33486
GSK Investigational Site
Cincinnati, Ohio, 45227
GSK Investigational Site
Forest Hills, New York, 11375
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Pasadena, California, 91105
GSK Investigational Site
Reseda, California, 91355
GSK Investigational Site
Richmond, Virginia, 23249
GSK Investigational Site
Tampa, Florida, 33612
GSK Investigational Site
Torrance, California, 90505
GSK Investigational Site
Ventura, California, 93003
South Korea5 sites
GSK Investigational Site
Busan, 602-715
GSK Investigational Site
Donggu Gwangju, 501757
GSK Investigational Site
Seoul, 138-736
GSK Investigational Site
Seoul, 152-703
GSK Investigational Site
Sungnam -Gyeonggi-do, 463707
Estonia3 sites
GSK Investigational Site
Tallinn, 10138
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tartu, 51014
Slovakia3 sites
GSK Investigational Site
Banská Bystrica, 974 04
GSK Investigational Site
Bratislava, 813 69
GSK Investigational Site
Bratislava, 831 03
About this study
Official title: A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's Disease
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn \& Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK\&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
- Conditions
- Parkinson Disease
- Being tested
- ropinirole monotherapy, placebo monotherapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropinirole monotherapyDrug
ropinirole as monotherapy in Parkinson's disease
placebo monotherapyDrug
placebo as monotherapy in Parkinson's disease
| Study group | Role | What they receive |
|---|---|---|
| ropinirole | Experimental | ropinirole 2, 4, 8, 12, or 24 mg/day Receives: Drug: ropinirole monotherapy |
| placebo | Placebo comparator | placebo comparator 2, 4, 8, 12, or 24 mg/day Receives: Drug: ropinirole monotherapy; Drug: placebo monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Secondary outcomes (10)
Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score
The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score
The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date.
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score
The responder rate is defined as the percentage of participants with a greater than or equal to (>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in UPDRS Parts II and III Combined
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in UPDRS Activities of Daily Living
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in the Total UPDRS Score (Parts I-III)
The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in the UPDRS Part I (Mentation)
The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the "on" phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Measured: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Responder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) Scale
The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse, 6 = "much worse", and 7 = "very much worse". The responder rate is defined as the percentage of participants with a score of 1 or 2.
Measured: Week 4 of the Maintenance Period (Study Week 17)
Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy
The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here.
Measured: Up to Week 4 of the Maintenance Period (Study Week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study start31 Jan 2012
- Primary completion30 Apr 2014
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485172
- Sponsor's protocol ID
- 111662
- Acronym
- TANDEM-662
- Status last verified
- Jun 2018
- First submitted
- 1 Dec 2011
- Last updated
- 20 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01485172
- Acronym / sponsor ID
- TANDEM-662 / 111662
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2012 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Posted 2 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn \& Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK\&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropinirole | Experimental | Drug: ropinirole monotherapyropinirole 2, 4, 8, 12, or 24 mg/day |
| placebo | Placebo comparator | Drug: ropinirole monotherapy, Drug: placebo monotherapyplacebo comparator 2, 4, 8, 12, or 24 mg/day |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of idiopathic Parkinson's disease (according to modified Hoehn \& Yahr criteria Stages I-III.)
- Subjects aged 30 years or greater at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for at least one month prior to randomization and one month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, surgical sterilisation, male partner sterilization, intrauterine device [IUD], or double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository.
- A baseline UPDRS motor score of at least 10.
- Limited prior exposure to low or moderate doses of L-DOPA (up to 3 months in total) or dopamine agonists including ropinirole (up to 6 months in total) is allowed provided treatment is discontinued for a minimum of 4 weeks prior to screening.
- Provide written informed consent for this study.
Key exclusion criteria (16 listed)
- Subjects with Parkinson's disease in whom dopaminergic therapy is not warranted at the time of screening.
- Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, render the subject unsuitable for the study (e.g., psychiatric, haematological, renal, hepatic, endocrinology, neurological [other than Parkinson's disease], cardiovascular, or active malignancy [other than basal cell carcinoma]).
- Subjects with crippling degenerative arthritis or other physical or mental conditions precluding accurate assessment of efficacy or safety.
- Subjects with prior or current major psychosis (e.g., schizophrenia or psychotic depression) e.g. scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
- Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1 [mentation].
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 |
|---|---|---|
| ropinirole monotherapyropinirole as monotherapy in Parkinson's disease | Drug | placebo, ropinirole |
| placebo monotherapyplacebo as monotherapy in Parkinson's disease | Drug | placebo |
Primary outcome
Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).
10 secondary outcomes
Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in UPDRS Parts II and III Combined
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in UPDRS Activities of Daily Living
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in the Total UPDRS Score (Parts I-III)
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in the UPDRS Part I (Mentation)
Time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Responder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) Scale
Time frame: Week 4 of the Maintenance Period (Study Week 17)
Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy
Time frame: Up to Week 4 of the Maintenance Period (Study Week 17)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropinirole monotherapy in people with Parkinson Disease, run by GlaxoSmithKline at 34 sites in 5 countries.
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 6 inclusion and 16 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Russia, United States, South Korea, Estonia, Slovakia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score (time frame: Baseline and Week 4 of the Maintenance Period (Study Week 17)). It is what the study was designed to measure, not a finding.
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 20 Jun 2018.