Parkinson DiseasePhase 2NCT03242499
Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease
A Phase 2 study testing Lovastatin in people with Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background: Recent evidence has shown that statins, especially lipophilic statins, may have a neuroprotective benefit in Parkinson's disease (PD). We aim to perform a randomized placebo-controlled trial evaluating the disease-modifying efficacy of lovastatin in patients with early stage PD. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Lovastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2017to 31 Dec 2019
- Phase
- Phase 2
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is informed and given ample time and opportunity to think about his/her participation in this study and has given his/her written informed consent on an Independent Review Board (IRB) approved consent form.
- Patient is considered reliable and capable of adhering to the protocol, visit schedule, or medication administration according to the judgment of the investigator.
- Patient has a documented history of idiopathic PD consistent with the UK Parkinson's Disease Society Brain Bank Diagnostic criteria [14] prior to the Screening Visit.
- Modified Hoehn and Yahr stage =1 in the off medication state (stop medications for 1 month)
- Patients did not previously receive any anti-parkinsonism medications (drug naïve) or had stopped medications for at least 1 month.
- Age 30-90 years
Who cannot join
- Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
- Patient has known abnormality on brain CT or MRI imaging considered to be causing symptoms or signs of neurological dysfunction.
- Prior intracerebral surgical intervention for PD including deep brain stimulation (DBS).
- Prior or current use of statins as a lipid lowering therapy
- End stage renal disease (creatinine clearance eGFR <30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
- Abnormal liver function with aspartate transaminase (AST) or alanine transaminase (ALT) >2 x upper normal limit.
Show all 11Show fewer
- Creatine kinase (CK) >2 x upper normal limit of normal.
- History of myopathy or rhabdolyolysis.
- Females who are pregnant or breast feeding.
- Patient has a history of chronic alcohol or drug abuse within the last 2 years.
- Exposure to neuroleptics (antipsychotic drugs) for more than 1 month within the past 2 years, or any exposure within the past year (except for quetiapine).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chin-Hsien Lin, MD,PhD, 886-2-3123456 ext. 65335, chlin@ntu.edu.tw
Chin-Hsien Lin, MD,PhD
About this study
Official title: Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease: a Single-center, Double-blind, Placebo-controlled Randomized Trial
Background: Recent evidence has shown that statins, especially lipophilic statins, may have a neuroprotective benefit in Parkinson's disease (PD). We aim to perform a randomized placebo-controlled trial evaluating the disease-modifying efficacy of lovastatin in patients with early stage PD.
Methods and Study Design: This study will be a phase II, single-center, double-blind, randomized, placebo-controlled parallel-group study. In this trial, we are going to examine the possibility that lovastatin, a highly potent lipophilic statin, has disease-modifying effects in PD. We are going to enroll 80 patients with early stage PD patients. Subjects will then be randomized to a 48-week double-blind treatment period of lovastatin 80mg/day or placebo. Primary endpoints are changes in motor severity based on Movement Disorder Society-Unified Parkinson's Disease Rating Scale motor sub-score (MDS-UPDRS part III, with higher numbers indicating more severe disease). During the follow-up period, the dose of anti-parkinsonism could be added if both the patients and doctors thought the clinical condition deteriorated. Changes in PD medication as measured by levodopa-equivalent dose (LED) will be recorded at each visit. The secondary endpoints measured include MDS-UPDRS total scores, Part I and Part II sub-scores, the timing and dose of added anti-parkinsonism medication during the treatment period, the changes of 18F-DOPA PET uptake and MMSE scores, and global impression scale (GCI) of patients and investigators at the end of the study.
Read more
Expected results: We hypothesize that lovastatin would slow down both motor and cognitive symptoms deterioration and dopaminergic neuronal degeneration in patients with early stage PD.
Importance of the study: Our study will provide Class II evidence that intensive lipid lowering with lovastatin 80 mg/day decrease the disease progression in patients with early stage PD.
Read the detailed description
This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel-group, 2-arm study in patients with mild to moderate PD. There will be three phases to the study. An initial 12-week screening phase was performed to determine eligibility. After informed consents, early-stage PD patients with Hoehn-Yahr stage 1 will be enrolled and participants will be asked to stop previously used anti-parkinsonism medications for at least one month to see the baseline disease severity. At the start of the study, participants will receive a comprehensive parkinsonism symptoms evaluation using Movement Disorder Society-Unified Parkinson's disease rating scale (MDS-UPDRS), global cognitive test using MMSE, and will be arranged for 18F-DOPA PET scan to evaluate the dopaminergic reserve in the striatum. Participants will also be asked to fasting for at least 8 hours to check the baseline laboratory test, including liver/renal functions, lipid profiles and serum CK level. Subjects will then be randomized to a 48-week double-blind treatment period of oral lovastatin 80mg/day or placeboSubjects in both groups will attend a further 5 clinic visits after 4, 12, 24, 36, and 48 weeks, where they are asked about their neurological symptoms and are evaluated by MDS-UPDRS. During the follow-up period, the dose of anti-parkinsonism could be added if both the patients and doctors thought the clinical condition deteriorated. Changes in PD medication as measured by levodopa-equivalent dose (LED) will be recorded at each visit. At final visit, patients will be arranged to receive the follow up 18F-DOPA PET scan to evaluate the dopaminergic reservation in the striatum and received MDS-UPDRS and MMSE evaluation. The secondary endpoints measured include MDS-UPDRS total scores, Part I and Part II sub-scores, the timing and dose of added anti-parkinsonism medication during the treatment period, the changes of 18F-DOPA PET uptake and MMSE scores, and global impression scale (GCI) of patients and investigators at the end of the study.
After informed consent form is completed, each patient will participate in the study for up to 48 weeks (a Screening Period of ≤12 weeks, followed by a Baseline Visit, 48 weeks of double-blind treatment, and a 4-week post-dose Safety Follow-up Visit) The post-dose Safety Follow-up Visit is for patients early terminating or not willing to participate in the open-label extension study):
- Screening Period: 16 weeks
- Treatment Period: 48 weeks
- Safety Follow-Up Period: 4 weeks After completion of the Treatment Period in this double-blind, placebo-controlled study, patients will be offered the option to enroll in an open-label extension study until 5 years. The end of the study is defined as the date of the last visit of the last patient in the study.
- Conditions
- Parkinson Disease
- Being tested
- Lovastatin, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovastatinDrug
Also called LOVASTATIN "YUNG SHIN"
Lovastatin 80mg or placebo use for 48 weeks.
PlaceboDrug
placebo for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Lovastatin 80mg per day for 48 weeks. Receives: Drug: Lovastatin |
| Placebo | Placebo comparator | Placebo 80mg per day for 48 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of MDS-UPDRS Part III (motor subscale) from baseline to week 48
Measure the motor symptoms severity changes of Parkinson's disease
Measured: After informed consent form is completed, each patient will participate in the study for up to 48 weeks (a Screening Period of ≤12 weeks, followed by a Baseline Visit, 48 weeks of double-blind treatment, and a 4-week post-dose Safety Follow-up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start15 May 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Hsien Lin, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242499
- Sponsor's protocol ID
- NCTRC201702
- Status last verified
- May 2017
- First submitted
- 1 Aug 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease: a Single-center, Double-blind, Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT03242499
- Acronym / sponsor ID
- NCTRC201702
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Aug 2017 (actual)
- 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.
Background: Recent evidence has shown that statins, especially lipophilic statins, may have a neuroprotective benefit in Parkinson's disease (PD). We aim to perform a randomized placebo-controlled trial evaluating the disease-modifying efficacy of lovastatin in patients with early stage PD.
Methods and Study Design: This study will be a phase II, single-center, double-blind, randomized, placebo-controlled parallel-group study. In this trial, we are going to examine the possibility that lovastatin, a highly potent lipophilic statin, has disease-modifying effects in PD. We are going to enroll 80 patients with early stage PD patients. Subjects will then be randomized to a 48-week double-blind treatment period of lovastatin 80mg/day or placebo. Primary endpoints are changes in motor severity based on Movement Disorder Society-Unified Parkinson's Disease Rating Scale motor sub-score (MDS-UPDRS part III, with higher numbers indicating more severe disease). During the follow-up period, the dose of anti-parkinsonism could be added if both the patients and doctors thought the clinical condition deteriorated. Changes in PD medication as measured by levodopa-equivalent dose (LED) will be recorded at each visit. The secondary endpoints measured include MDS-UPDRS total scores, Part I and Part II sub-scores, the timing and dose of added anti-parkinsonism medication during the treatment period, the changes of 18F-DOPA PET uptake and MMSE scores, and global impression scale (GCI) of patients and investigators at the end of the study.
Expected results: We hypothesize that lovastatin would slow down both motor and cognitive symptoms deterioration and dopaminergic neuronal degeneration in patients with early stage PD.
Importance of the study: Our study will provide Class II evidence that intensive lipid lowering with lovastatin 80 mg/day decrease the disease progression in patients with early stage PD.
Detailed description
This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel-group, 2-arm study in patients with mild to moderate PD. There will be three phases to the study. An initial 12-week screening phase was performed to determine eligibility. After informed consents, early-stage PD patients with Hoehn-Yahr stage 1 will be enrolled and participants will be asked to stop previously used anti-parkinsonism medications for at least one month to see the baseline disease severity. At the start of the study, participants will receive a comprehensive parkinsonism symptoms evaluation using Movement Disorder Society-Unified Parkinson's disease rating scale (MDS-UPDRS), global cognitive test using MMSE, and will be arranged for 18F-DOPA PET scan to evaluate the dopaminergic reserve in the striatum. Participants will also be asked to fasting for at least 8 hours to check the baseline laboratory test, including liver/renal functions, lipid profiles and serum CK level. Subjects will then be randomized to a 48-week double-blind treatment period of oral lovastatin 80mg/day or placeboSubjects in both groups will attend a further 5 clinic visits after 4, 12, 24, 36, and 48 weeks, where they are asked about their neurological symptoms and are evaluated by MDS-UPDRS. During the follow-up period, the dose of anti-parkinsonism could be added if both the patients and doctors thought the clinical condition deteriorated. Changes in PD medication as measured by levodopa-equivalent dose (LED) will be recorded at each visit. At final visit, patients will be arranged to receive the follow up 18F-DOPA PET scan to evaluate the dopaminergic reservation in the striatum and received MDS-UPDRS and MMSE evaluation. The secondary endpoints measured include MDS-UPDRS total scores, Part I and Part II sub-scores, the timing and dose of added anti-parkinsonism medication during the treatment period, the changes of 18F-DOPA PET uptake and MMSE scores, and global impression scale (GCI) of patients and investigators at the end of the study.
After informed consent form is completed, each patient will participate in the study for up to 48 weeks (a Screening Period of ≤12 weeks, followed by a Baseline Visit, 48 weeks of double-blind treatment, and a 4-week post-dose Safety Follow-up Visit) The post-dose Safety Follow-up Visit is for patients early terminating or not willing to participate in the open-label extension study):
- Screening Period: 16 weeks
- Treatment Period: 48 weeks
- Safety Follow-Up Period: 4 weeks After completion of the Treatment Period in this double-blind, placebo-controlled study, patients will be offered the option to enroll in an open-label extension study until 5 years. The end of the study is defined as the date of the last visit of the last patient in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: LovastatinLovastatin 80mg per day for 48 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 80mg per day for 48 weeks. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is informed and given ample time and opportunity to think about his/her participation in this study and has given his/her written informed consent on an Independent Review Board (IRB) approved consent form.
- Patient is considered reliable and capable of adhering to the protocol, visit schedule, or medication administration according to the judgment of the investigator.
- Patient has a documented history of idiopathic PD consistent with the UK Parkinson's Disease Society Brain Bank Diagnostic criteria [14] prior to the Screening Visit.
- Modified Hoehn and Yahr stage =1 in the off medication state (stop medications for 1 month)
- Patients did not previously receive any anti-parkinsonism medications (drug naïve) or had stopped medications for at least 1 month.
Key exclusion criteria (11 listed)
- Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
- Patient has known abnormality on brain CT or MRI imaging considered to be causing symptoms or signs of neurological dysfunction.
- Prior intracerebral surgical intervention for PD including deep brain stimulation (DBS).
- Prior or current use of statins as a lipid lowering therapy
- End stage renal disease (creatinine clearance eGFR <30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
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 |
|---|---|---|
| LovastatinAlso: LOVASTATIN "YUNG SHIN"Lovastatin 80mg or placebo use for 48 weeks. | Drug | Active |
| Placeboplacebo for 48 weeks | Drug | Placebo |
Primary outcome
Changes of MDS-UPDRS Part III (motor subscale) from baseline to week 48
Time frame: After informed consent form is completed, each patient will participate in the study for up to 48 weeks (a Screening Period of ≤12 weeks, followed by a Baseline Visit, 48 weeks of double-blind treatment, and a 4-week post-dose Safety Follow-up Visit
Measure the motor symptoms severity changes of Parkinson's disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Chin-Hsien Lin, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lovastatin in people with Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 11 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: status not confirmed, as of the sponsor's last update on 17 Oct 2017. 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Hsien Lin, MD, PhD (886-2-23123456 ext. 65335, chlin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of MDS-UPDRS Part III (motor subscale) from baseline to week 48 (time frame: After informed consent form is completed, each patient will participate in the study for up to 48 weeks (a Screening Period of ≤12 weeks, followed by a Baseline Visit, 48 weeks of double-blind treatment, and a 4-week post-dose Safety Follow-up Visit). 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 17 Oct 2017.