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| ID | Type | Description | Link |
|---|---|---|---|
| MREC: 07/Q1602/73 | Other Identifier | MREC | |
| 2006-006347-31 | EudraCT Number |
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To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.
The study has now completed see Primary publication:
Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial.
Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR, Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas R.
Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Simvastatin 80mg OD |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | 80mg simvastatin oral once daily for 24 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Whole Brain Volume | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Disability (EDSS). | Score (0 to 10), lower score less disability and better progression. For EDSS, mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables. | 24 months |
| Evaluation of Disability (MSFC Z Score). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Chataway, MB BCh, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRI Unit, National Society for Epilepsy, Chesham Lane | Chalfont Saint Peter | Buckinghamshire | SL9 0RJ | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28600189 | Result | Chan D, Binks S, Nicholas JM, Frost C, Cardoso MJ, Ourselin S, Wilkie D, Nicholas R, Chataway J. Effect of high-dose simvastatin on cognitive, neuropsychiatric, and health-related quality-of-life measures in secondary progressive multiple sclerosis: secondary analyses from the MS-STAT randomised, placebo-controlled trial. Lancet Neurol. 2017 Aug;16(8):591-600. doi: 10.1016/S1474-4422(17)30113-8. Epub 2017 Jun 7. | |
| 24655729 |
Not provided
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We are still analysing post-hoc data. The International Progressive MS Alliance have access to some of the data.
next 2 years
via the CI
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| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin 80mg OD | Simvastatin: 80mg simvastatin oral once daily for 24 months |
| FG001 | Placebo | Placebo: Oral placebo tablet once daily for 24 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin 80mg OD | Simvastatin: 80mg simvastatin oral once daily for 24 months |
| BG001 | Placebo | Placebo: Oral placebo tablet once daily for 24 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Whole Brain Volume | 1 participant had a missing data | Posted | Mean | Standard Deviation | percentage of brain volumen change | 24 months |
|
|
Collected over 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simvastatin 80mg OD | Simvastatin: 80mg simvastatin oral once daily for 24 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 relapse (requiring hospital admission) | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Relapse | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | relapse of MS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Jeremy Chataway, Chief Investigator | University of London | 07974752295 | j.chataway@ucl.ac.uk |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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RCT
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over-encapsulation of IMP
| Placebo |
| Drug |
Oral placebo tablet once daily for 24 months |
|
Negative value implies worsening and a positive value implies improvement. |
| 24 months |
| Evaluation of Disability (MSFC Walk). | The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. | 24 months |
| Evaluation of Disability (MSFC Peg Test). | The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. | 24 months |
| Evaluation of Disability (MSFC PASAT). | The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. Shorter inter-stimulus intervals, e.g., 2 seconds or less have also been used with the PASAT but tend to increase the difficulty of the task. Score 0 to 60, higher score less disability. | 24 months |
| Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Total Score) | The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales is scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates a greater impact of the disease on daily function (worse health). | 24 months |
| Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Physical Score) | The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health). | 24 months |
| Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Psychological Score) | The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales is scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates a greater impact of the disease on daily function (worse health). | 24 months |
| Charing Cross Hospital, Fulham Palace Road |
| Hammersmith |
| London |
| W6 8RF |
| United Kingdom |
| Brighton & Sussex University Hospitals NHS Trust, Eastern Road | Brighton | BN2 5BE | United Kingdom |
| Result |
| Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR, Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas R. Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial. Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4. Epub 2014 Mar 19. |
| 35031587 | Derived | Williams TE, Holdsworth KP, Nicholas JM, Eshaghi A, Katsanouli T, Wellington H, Heslegrave A, Zetterberg H, Frost C, Chataway J. Assessing Neurofilaments as Biomarkers of Neuroprotection in Progressive Multiple Sclerosis: From the MS-STAT Randomized Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Jan 14;9(2):e1130. doi: 10.1212/NXI.0000000000001130. Print 2022 Mar. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Evaluation of Disability (EDSS). | Score (0 to 10), lower score less disability and better progression. For EDSS, mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
|
| Secondary | Evaluation of Disability (MSFC Z Score). | Negative value implies worsening and a positive value implies improvement. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Secondary | Evaluation of Disability (MSFC Walk). | The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. | Posted | Mean | Standard Deviation | foot per second | 24 months |
|
|
|
| Secondary | Evaluation of Disability (MSFC Peg Test). | The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. | Posted | Mean | Standard Deviation | speed per second | 24 months |
|
|
|
| Secondary | Evaluation of Disability (MSFC PASAT). | The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. Shorter inter-stimulus intervals, e.g., 2 seconds or less have also been used with the PASAT but tend to increase the difficulty of the task. Score 0 to 60, higher score less disability. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Secondary | Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Total Score) | The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales is scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates a greater impact of the disease on daily function (worse health). | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Secondary | Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Physical Score) | The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health). | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Secondary | Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Psychological Score) | The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales is scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates a greater impact of the disease on daily function (worse health). | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| 0 |
| 70 |
| 9 |
| 70 |
| 49 |
| 70 |
| EG001 | Placebo | Placebo: Oral placebo tablet once daily for 24 months | 0 | 70 | 14 | 70 | 54 | 70 |
| Abdominal Lesion Biopsy | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Appendectomy | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Seizures | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Increased spasticity | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sub-arachnoid haemorrhage | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Viral encephalitis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| cramp | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | cramp |
|
| headache | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | headache |
|
| pain | General disorders | MedDRA (10.0) | Systematic Assessment | pain |
|
| worsening mobility | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | worsening mobility |
|
| increase spasticity | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | spasticity |
|
| Urinary infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment | UTI |
|
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| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |