Parkinson DiseasePhase 2PD STATNCT02787590
Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease
A Phase 2 study testing Simvastatin in people with Parkinson Disease, run by University Hospital Plymouth NHS Trust at 24 sites in United Kingdom.
Trial summary
Participants are randomly allocated to one of two treatment groups. In one group, participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In the other group, participants are given placebo (dummy) capsules to take orally for 24 months. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 24 sitesUnited Kingdom
- Study dates
- 8 Mar 2016to 31 Dec 2020
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD
- Modified Hoehn and Yahr stage ≤ 3.0 in the ON medication state
- Age 40-90 years
- On dopaminergic treatment with wearing-off phenomenon
- Able to comply with study protocol and willing to attend necessary study visits
Who cannot join
- Diagnosis or suspicion of other cause for parkinsonism
- Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with study protocol
- Concurrent dementia defined by MoCA score <21
- Concurrent severe depression defined by MADRS score >31
- Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation
- Already actively participating in a research study that might conflict with this trial
Show all 19Show fewer
- Prior or current use of statins as a lipid lowering therapy
- Intolerance to statins
- Untreated hypothyroidism
- End stage renal disease (creatinine clearance <30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
- eGFR <30 mL/min
- History of alcoholism or liver impairment
- Creatine kinase (CK) >1.1 x upper limit of normal (ULN)
- Aspartate transaminase (AST) or alanine transaminase (ALT) >1.1 x ULN
- Females who are pregnant or breast feeding or of child-bearing potential and unwilling to use appropriate contraception methods whilst on trial treatment
- Currently taking any medication contraindicated with simvastatin use (Appendix 2)
- Any requirement for statin use
- Regular participation in endurance or high-impact sports
- Unable to abstain from consumption of grapefruit-based products
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United Kingdom24 sites
Royal United Hospital
Bath
Royal Bournemouth Hospital
Bournemouth
Fairfield General Hospital
Bury
Addenbrooke's Hospital
Cambridge
St Peter's Hospital
Chertsey
Royal Devon and Exeter Hospital
Exeter
Leeds General Infirmary
Leeds
Charing Cross Hospital
London
King's College Hospital
London
Royal Free Hospital
London
Luton and Dunstable Hospital
Luton
Clinical Ageing Research Unit
Newcastle
Norfolk and Norwich University Hospital
Norwich
John Radcliffe Hospital
Oxford
Derriford Hospital
Plymouth
Royal Preston Hospital
Preston
Queen's Hospital
Romford
Rotherham General Hospital
Rotherham
Salford Royal Hospital
Salford
Royal Hallamshire Hospital
Sheffield
Royal Stoke University Hospital
Stoke-on-Trent
Musgrove Park Hospital
Taunton
Royal Cornwall Hospital
Truro
Yeovil District Hospital
Yeovil
About this study
Official title: Simvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity.
Participants are randomly allocated to one of two treatment groups. In one group, participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In the other group, participants are given placebo (dummy) capsules to take orally for 24 months. At the start of the study, when they receive their medication, participants complete a number of questionnaires and motor (movement) tests (a walking test and a finger tapping test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18 and 24 and 26 months, where they are asked about their health and any medication they are taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits, the participants will be asked to attend in the 'OFF medication' state (having omitted their usual PD medication) so that the researchers can get a true picture of their disease without it being masked by their normal medication.
- Conditions
- Parkinson Disease
- Being tested
- Simvastatin, Matched Placebo (for Simvastatin)
- Keywords
- Neurology
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Matched Placebo (for Simvastatin)Drug
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Active comparator | A one month low dose phase of 40mg oral simvastatin daily will be followed by a 23 month high dose phase of 80mg oral simvastatin daily and a final two month phase off trial medication Receives: Drug: Simvastatin |
| Matched Placebo | Placebo comparator | A one month low dose phase of 40mg matched placebo daily will be followed by a 23 month high dose phase of 80mg matched placebo daily and a final two month phase off trial medication Receives: Drug: Matched Placebo (for Simvastatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MDS-UPDRS part III (OFF) score
The MDS-UPDRS is the standard validated tool for the assessment of patients with Parkinson's Disease. This scale includes subsections collecting data regarding the impact of PD on a patient's mood and mental state, (UPDRS part I), their activities of daily living (UPDRS part II) an examination of the motor features of PD (UPDRS part III), and complications arising from the use of dopamine replacement (part IV).
Measured: Baseline and 24 Months
Secondary outcomes (13)
MDS-UPDRS total score in the practically defined ON state
Measured: at 12 and 24 months
MDS-UPDRS part II subscale score in the practically defined ON state
Measured: at 12 and 24 months
Timed motor tests - finger tapping and timed walk test (10MWT) in the OFF state, electromagnetic sensor (EMS) assessment in the OFF and ON state
Timed Motor Tests include evaluating the number of hand taps (key strokes) that an individual can perform within 30 seconds and a timed walk test (10MWT). Electromagnetic Sensor Measurements include wearing sensors on the index finger and thumb whilst performing 4 MDS-UPDRS items.
Measured: at 12 and 24 months
Montgomery and Asberg Depression Rating Scale (MADRS)
The Montgomery and Asberg Depression Rating Scale (MADRS) is a 10 item physician rated depression severity scale previously used in the assessment of PD
Measured: at 12 and 24 months
The Addenbrooke's Cognitive Assessment-III (ACE-III)
The Addenbrooke's Cognitive Examination-III (ACE) is one of the most popular and PD STAT protocol version 2.2, 03 March 2016 EudraCT 2015-000148-40 ISRCTN16108482. REC Ref:15/NE/0324 Page 39 of 43 commonly used cognitive tests used in dementia clinics and in the assessment of other neurological disorders. ACE-III includes five subdomains which provide a cognitive score out of a maximum of 100
Measured: at 12 and 24 months
Non-Motor Symptom assessment scale (NMSS)
The Non-Motor Symptom assessment scale (NMSS) is a rating scale designed to capture the presence of the non-motor features of PD
Measured: at 12 and 24 months
Parkinson's disease Questionnaire (PDQ-39)
The PDQ39 is a PD-specific health status questionnaire used both clinically and within research since its publication in 1995. It consists of 39 items covering eight discrete dimensions: mobility, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. The scores from each dimension are computed into a scale ranging from 0 (best, i.e. no problem at all) to 100 (worst, i.e. maximum level of problem). In addition a summary score, the PDQ-39SI (summary index) can be calculated by averaging the scores of the eight dimensions.
Measured: at 12 and 24 months
Changes in PD medication as measured by levodopa-equivalent dose (LED)
Measured: at 12 and 24 months
Cholesterol levels (total, HDL, total/HDL ratio)
Measured: at 12 and 24 months
King's PD pain scale (KPPS)
The King's PD Pain Scale is a PD-specific scale consisting of 14 items within seven domains. Each item is scored by severity (0-3) multiplied by frequency (0-4), resulting in an item sub-score of 0-12 and a total possible score of 0-168.
Measured: at 12 and 24 months
EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)
Measured: at 12 and 24 months
Safety and tolerability of trial medication by adverse events (AEs) review.
Measured: at 12 and 24 months
Incidence of diabetes mellitus, using a glycated haemoglobin (HbA1c) level of 6.5% (48mmol/mol) as diagnostic of diabetes mellitus.
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start8 Mar 2016
- Primary completion1 Nov 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Plymouth
- Responsible party
- Sponsor
- Investigators
- Camille B Carroll, BM BCh, PhD, Study director, Clinical Lecturer (University of Plymouth) and Honorary Consultant Neurologist, Plymouth Hospitals NHS Trust.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787590
- Sponsor's protocol ID
- PDSTAT2015
- Other IDs
- 2015-000148-40, 16108482, 2015
- Acronym
- PD STAT
- Status last verified
- Oct 2021
- First submitted
- 26 May 2016
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data sharing plans for the current study are unknown and will be made available at a later date
Publications
Carroll CB, Webb D, Stevens KN, Vickery J, Eyre V, Ball S, Wyse R, Webber M, Foggo A, Zajicek J, Whone A, Creanor S. Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study. BMJ Open. 2019 Oct 7;9(10):e029740. doi: 10.1136/bmjopen-2019-029740.
PubMed 31594876
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity.
- ClinicalTrials.gov ID
- NCT02787590
- Acronym / sponsor ID
- PD STAT / PDSTAT2015
- Conditions
- Parkinson Disease
- Keywords
- Neurology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Collaborators
- University of Plymouth
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Jun 2016 (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.
Participants are randomly allocated to one of two treatment groups. In one group, participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In the other group, participants are given placebo (dummy) capsules to take orally for 24 months. At the start of the study, when they receive their medication, participants complete a number of questionnaires and motor (movement) tests (a walking test and a finger tapping test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18 and 24 and 26 months, where they are asked about their health and any medication they are taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits, the participants will be asked to attend in the 'OFF medication' state (having omitted their usual PD medication) so that the researchers can get a true picture of their disease without it being masked by their normal medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Active comparator | Drug: SimvastatinA one month low dose phase of 40mg oral simvastatin daily will be followed by a 23 month high dose phase of 80mg oral simvastatin daily and a final two month phase off trial medication |
| Matched Placebo | Placebo comparator | Drug: Matched Placebo (for Simvastatin)A one month low dose phase of 40mg matched placebo daily will be followed by a 23 month high dose phase of 80mg matched placebo daily and a final two month phase off trial medication |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic PD
- Modified Hoehn and Yahr stage ≤ 3.0 in the ON medication state
- Age 40-90 years
- On dopaminergic treatment with wearing-off phenomenon
- Able to comply with study protocol and willing to attend necessary study visits
Key exclusion criteria (19 listed)
- Diagnosis or suspicion of other cause for parkinsonism
- Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with study protocol
- Concurrent dementia defined by MoCA score <21
- Concurrent severe depression defined by MADRS score >31
- Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation
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 |
|---|---|---|
| Simvastatin | Drug | Simvastatin |
| Matched Placebo (for Simvastatin) | Drug | Matched Placebo |
Primary outcome
Change in MDS-UPDRS part III (OFF) score
Time frame: Baseline and 24 Months
The MDS-UPDRS is the standard validated tool for the assessment of patients with Parkinson's Disease. This scale includes subsections collecting data regarding the impact of PD on a patient's mood and mental state, (UPDRS part I), their activities of daily living (UPDRS part II) an examination of the motor features of PD (UPDRS part III), and complications arising from the use of dopamine replacement (part IV).
13 secondary outcomes
MDS-UPDRS total score in the practically defined ON state
Time frame: at 12 and 24 months
MDS-UPDRS part II subscale score in the practically defined ON state
Time frame: at 12 and 24 months
Timed motor tests - finger tapping and timed walk test (10MWT) in the OFF state, electromagnetic sensor (EMS) assessment in the OFF and ON state
Time frame: at 12 and 24 months
Montgomery and Asberg Depression Rating Scale (MADRS)
Time frame: at 12 and 24 months
The Addenbrooke's Cognitive Assessment-III (ACE-III)
Time frame: at 12 and 24 months
Non-Motor Symptom assessment scale (NMSS)
Time frame: at 12 and 24 months
Parkinson's disease Questionnaire (PDQ-39)
Time frame: at 12 and 24 months
Changes in PD medication as measured by levodopa-equivalent dose (LED)
Time frame: at 12 and 24 months
Cholesterol levels (total, HDL, total/HDL ratio)
Time frame: at 12 and 24 months
King's PD pain scale (KPPS)
Time frame: at 12 and 24 months
EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)
Time frame: at 12 and 24 months
Safety and tolerability of trial medication by adverse events (AEs) review.
Time frame: at 12 and 24 months
Incidence of diabetes mellitus, using a glycated haemoglobin (HbA1c) level of 6.5% (48mmol/mol) as diagnostic of diabetes mellitus.
Time frame: at 24 months
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 18 Oct 2021.
- Derived from this study: PubMed 31594876Carroll CB, Webb D, Stevens KN, Vickery J, Eyre V, Ball S, Wyse R, Webber M, Foggo A, Zajicek J, Whone A, Creanor S. Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study. BMJ Open. 2019 Oct 7;9(10):e029740. doi: 10.1136/bmjopen-2019-029740.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data sharing plans for the current study are unknown and will be made available at a later date
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
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
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.
Camille B Carroll, BM BCh, PhD study director
Clinical Lecturer (University of Plymouth) and Honorary Consultant Neurologist, Plymouth Hospitals NHS Trust.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin in people with Parkinson Disease, run by University Hospital Plymouth NHS Trust at 24 sites 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 5 inclusion and 19 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 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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. 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?
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.
What does the primary outcome measure?
Change in MDS-UPDRS part III (OFF) score (time frame: Baseline and 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02787590, which also lists 1 linked publication.
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 18 Oct 2021.