Progressive Supranuclear PalsyTaurosNCT01049399
Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112 Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy
A study testing tideglusib in people with Progressive Supranuclear Palsy, run by Noscira SA at 24 sites in 4 countries.
Trial summary
The purpose of this study is to determine wether NP031112 is safe and effective in the treatment of mild to moderate Progressive Supranuclear Palsy Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- tideglusib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 24 sitesin 4 countries
- Study dates
- Dec 2009to Nov 2011
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with diagnosis of possible or probable PSP according to clinical criteria of National Institute of Neurologic Diseases and Stroke - the Society for PSP (Appendix 1).
- Age of 40 to 85 years (patients over 85 years could be included after previous assessment by Investigator and approved by sponsor).
- Brain magnetic resonance imaging (MRI) study within 24 months before Baseline visit excluding other potential causes of parkinsonism, especially cerebrovascular lesions and space occupying lesions.
- Mild-to-moderate stage of disease severity according to score of 1 to 4 in Golbe Staging System.(Appendix 2)
- Female patients must be surgically sterilized; at least 1 year postmenopausal (confirmed by follicle-stimulating hormone [FSH] >20 international units [IUs]); using adequate birth control (implants, injectables, combined oral contraceptives, intrauterine contraceptive device, total sexual abstinence during the study or vasectomised partner). Male patients must be willing to use barrier contraception (condom) during the study and for 6 months after last treatment administration.
- In European arms of study female patients must be without childbearing potential.
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- Caregiver (or dedicated nurse) living in same household or interacting with patient for >4 hours every day able to assure correct preparation and administration of study drug.
- Patients living at home or in retirement home not requiring continuous nursing care.
- General health status acceptable for participation in 64-week clinical trial.
- Ability to swallow 100 mL of water suspension.
- Any concomitant medication for PSP must be well-tolerated and unchanged for at least 1 month prior to Baseline visit and its dose and regimen should be maintained during study if there are no clinical reasons to modify it.
- Occupational, physical, respiratory, or speech therapy is allowed but it must be stable for at least 1 month prior to screening.
- Pharmacological treatment of any other chronic condition must be stable and well-tolerated for at least 1 month prior to screening. Analgesics, occasional per request nonsteroidal anti-inflammatory agents, and treatments for transient or emergent conditions are allowed.
- Signed informed consent by patient and permitted prior to initiation of any study-specific procedure.
Who cannot join
- Failure to perform screening or baseline examinations.
- Hospitalization or change of chronic concomitant medication 1 month prior to or during screening period (apart from pre-planned hospitalization for a condition, which did not deteriorate since 1 month prior to screening period).
- Clinical, laboratory or neuroimaging findings consistent with:
- other primary degenerative diseases such as Parkinson's disease; dementia with Lewy bodies; corticobasal degeneration; frontotemporal dementia; multiple system atrophy; parkinsonism-dementia complex of Guam, Kii or Guadeloupe; Alzheimer's disease; amyotrophic lateral sclerosis; Creutzfeldt-Jakob Disease; Huntington's disease; Down's syndrome; etc.
- cerebrovascular disease as major, strategic or multilacunar infarcts, or extensive white matter lesions scoring 3 in the Wahlund's scale [Wahlund et al., 2001].
- other central nervous system diseases (hydrocephalus, severe head trauma, tumours, subdural haematoma or other relevant space occupying processes, etc.).
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- epilepsy.
- other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, clinically significant serum electrolyte disturbances, juvenile onset diabetes mellitus, etc.).
- A current Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis of active major depression, schizophrenia or bipolar disorder.
- Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias clinical or mental assessment or put patient at special risk, such as:
- chronic liver disease, as indicated by liver function test abnormalities (ALAT, ASAT, bilirubin or GGT out of range) positive serology for Hepatitis C, or other manifestations of liver disease
- respiratory insufficiency
- renal insufficiency (serum creatinine >2 mg/dL (>150 micromol/L) and creatinine clearance <60 (according to Cockcroft-Gault formula)
- heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before screening).
- bradycardia (heart beat <50/min) or tachycardia (heart beat >95/min)
- episodes of unstable or uncontrolled hypertension (systolic pressure >160 mm Hg or diastolic pressure >100 mm Hg) or hypotension (systolic pressure <90 mm Hg or diastolic pressure <45 mm Hg) during 2 months prior to Baseline visit.
- atrioventricular block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF interval (males >450 msec and females >470 msec using Fridericia's formula: QTc = QT/cube root of RR).
- uncontrolled diabetes mellitus.
- malignant tumors within last 5 years except skin malignancies (other than melanoma) or indolent prostate cancer.
- metastases.
- Disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, and severe language difficulty).
- Chronic daily drug intake of:
- drugs metabolized by cytochrome P450 (CYP)3A4 with narrow therapeutic window (acenocoumarol, warfarin, and digitoxin)
- anticonvulsants indicated for epileptic seizures
- systemic anticholinergics with relevant action on central nervous system
- acetylcholinesterase inhibitors
- neuroleptics except quetiapine, clozapine or other atypical neuroleptics
- nootropics such as piracetam, propentofylline, hydergine, vinpocetine, ginkgo biloba, coenzyme Q-10, idebenone and derivatives
- centrally active anti-hypertensive drugs such as clonidine, alpha methyl dopa, guanidine, and guanfacine
- systemic cortico-steroids or immunosuppressants
- systemic nonsteroidal anti-inflammatory agents (except taken as occasional medication per request or acetylsalicylic acid up to 100 mg/day as an antiplatelet agent).
- memantine, lithium, valproic acid or other GSK-3 inhibitors within 3 months prior to the Baseline visit.
- Suspected or known history of drug abuse or excessive alcohol intake*
- Suspected or known allergy to any components of study treatments.
- Enrollment in another investigational drug study within 3 months before Baseline visit.
- Any condition, which in the opinion of Investigator makes patient unsuitable for inclusion or likely to be non-compliant.
- More than 21 units per week for men and 14 for women; or consumption of more than 8 units in a single episode. 1 unit equals approximately 1 glass of wine, 250 ml of beer or 1 shot (25 ml) of spirit.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Spain9 sites
Hospital de Cruces
Barakaldo, 48902
Fundació Ace
Barcelona, Barcelona, 08014
Dpto.neurologia. H. Clinic.
Barcelona, 08036
Hospital de Donostia
Donostia / San Sebastian, 20014
Hospital Puerta del Hierro
Madrid, Madrid, 28222
Dpt. Neurologia. Hospital Ramón y Cajal.
Madrid, 28034
Hospital U. La Paz
Madrid, 28046
Hospital Mutua Terrassa
Terrassa, 8221
Departement of Neurology, Hospital La Fe
Valencia, 460009
United States6 sites
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Department of Neurology, David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Division of Movement Disorders, University of Louisville
Louisville, Kentucky, 40202
University of Medicine and Dentistry, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
University of South Florida 5
Tampa, Florida, 33606
Germany6 sites
Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson Beelitz
Beelitz-Heilstätten, 14547
Humboldt Universitat Charite, Campus Virchow, Neurologisch
Berlin, 13353
Universitatsklinikum Carl-Guslav-Carus, Technische Universitat Dresden, Klinik und Poliklinik fur Neurologie
Dresden, 01307
Medizinische Hochschule Hannover, Neurologie 0E 7210
Hanover, 30625
Zentrum fur Nervenheilkunde. Klinik fur Neurologie mit Poliklinik.
Marburg, 35039
University Hospital Tuebingen,Eberhard-Karls-Universitat, Universitatsklinikum Neurologie
Tübingen, 72076
United Kingdom3 sites
The Walton Centre for Neurology and Neurosurgery NHS Trust
Liverpool, L9 7LJ
Reta Lila Weston Institute of Neurological Studies,Sara Koe PSP Research Centre
London, WC1N 1PJ
Clinical Ageing Research Unit
Newcastle upon Tyne, NE4 5PL
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112, a GSK-3 Inhibitor, Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy
The purpose of this study is to determine wether NP031112 is safe and effective in the treatment of mild to moderate Progressive Supranuclear Palsy
- Conditions
- Progressive Supranuclear Palsy
- Being tested
- tideglusib, placebo
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tideglusibDrug
Also called NP031112
800 mg of tideglusib as a powder for oral suspension once daily in fasting conditions for 52 weeks
tideglusibDrug
Also called NP031112
600 mg of tideglusib as a powder for oral suspension, administered once daily in fasting conditions for 52 weeks
placeboDrug
powder for oral suspension administered once daily in fasting conditions for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | once daily administration of powder for oral suspension. Receives: Drug: placebo |
| NP031112 800 mg | Experimental | Group dosed with 800 mg once daily for 52 weeks Receives: Drug: tideglusib |
| NP031112 600 mg | Experimental | Group treated with 600 mg once daily for 52 weeks Receives: Drug: tideglusib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from Baseline between the 2 active study medication groups compared with the placebo group in the Progressive Supranuclear Palsy Rating Scale of Golbe
Measured: 52 weeks
Secondary outcomes (8)
Number of AEs and patients with an incidence rate of ≥ 5% AEs
Measured: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Modified Schwab and England Scale
Measured: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Timed Up and Go Test (quantitative motor function)
Measured: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in cognitive function(Dementia Rating Scale-2,Frontal Assessment Battery,category and letter verbal fluency)
Measured: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Starkstein Apathy Scale (behavior)
Measured: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in functional assessments(Unified Parkinson Disease rating Scale part II and European Quality of Life questionnaire)
Measured: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Clinical Global Impression of Change
Measured: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Clinical Global Impression of Severity
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Progressive Supranuclear PalsyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noscira SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i3 Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049399
- Sponsor's protocol ID
- NP031112-08B02
- Acronym
- Tauros
- Status last verified
- Jan 2012
- First submitted
- 13 Jan 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quattrone A, Franzmeier N, Huppertz HJ, Klietz M, Roemer SN, Boxer AL, Levin J, Hoglinger GU; AL-108-231 Investigators, the Tauros MRI Investigators, the PASSPORT Study Group, the DESCRIBE-PSP Group. Magnetic Resonance Imaging Measures to Track Atrophy Progression in Progressive Supranuclear Palsy in Clinical Trials. Mov Disord. 2024 Aug;39(8):1329-1342. doi: 10.1002/mds.29866. Epub 2024 Jun 2.
PubMed 38825840Hoglinger GU, Schope J, Stamelou M, Kassubek J, Del Ser T, Boxer AL, Wagenpfeil S, Huppertz HJ; AL-108-231 Investigators; Tauros MRI Investigators; Movement Disorder Society-Endorsed PSP Study Group. Longitudinal magnetic resonance imaging in progressive supranuclear palsy: A new combined score for clinical trials. Mov Disord. 2017 Jun;32(6):842-852. doi: 10.1002/mds.26973. Epub 2017 Apr 24.
PubMed 28436538
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112, a GSK-3 Inhibitor, Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT01049399
- Acronym / sponsor ID
- Tauros / NP031112-08B02
- Conditions
- Progressive Supranuclear Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Noscira SAIndustry (pharma, biotech, devices)
- Collaborators
- i3 Research
- Study start
- Dec 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Jan 2010 (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.
The purpose of this study is to determine wether NP031112 is safe and effective in the treatment of mild to moderate Progressive Supranuclear Palsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboonce daily administration of powder for oral suspension. |
| NP031112 800 mg | Experimental | Drug: tideglusibGroup dosed with 800 mg once daily for 52 weeks |
| NP031112 600 mg | Experimental | Drug: tideglusibGroup treated with 600 mg once daily for 52 weeks |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women with diagnosis of possible or probable PSP according to clinical criteria of National Institute of Neurologic Diseases and Stroke - the Society for PSP (Appendix 1).
- Age of 40 to 85 years (patients over 85 years could be included after previous assessment by Investigator and approved by sponsor).
- Brain magnetic resonance imaging (MRI) study within 24 months before Baseline visit excluding other potential causes of parkinsonism, especially cerebrovascular lesions and space occupying lesions.
- Mild-to-moderate stage of disease severity according to score of 1 to 4 in Golbe Staging System.(Appendix 2)
- Female patients must be surgically sterilized; at least 1 year postmenopausal (confirmed by follicle-stimulating hormone [FSH] >20 international units [IUs]); using adequate birth control (implants, injectables, combined oral contraceptives, intrauterine contraceptive device, total sexual abstinence during the study or vasectomised partner). Male patients must be willing to use barrier contraception (condom) during the study and for 6 months after last treatment administration.
Key exclusion criteria (37 listed)
- Failure to perform screening or baseline examinations.
- Hospitalization or change of chronic concomitant medication 1 month prior to or during screening period (apart from pre-planned hospitalization for a condition, which did not deteriorate since 1 month prior to screening period).
- Clinical, laboratory or neuroimaging findings consistent with:
- A current Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis of active major depression, schizophrenia or bipolar disorder.
- Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias clinical or mental assessment or put patient at special risk, such as:
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 |
|---|---|---|
| tideglusibAlso: NP031112800 mg of tideglusib as a powder for oral suspension once daily in fasting conditions for 52 weeks | Drug | NP031112 800 mg |
| tideglusibAlso: NP031112600 mg of tideglusib as a powder for oral suspension, administered once daily in fasting conditions for 52 weeks | Drug | NP031112 600 mg |
| placebopowder for oral suspension administered once daily in fasting conditions for 52 weeks | Drug | Placebo |
Primary outcome
The change from Baseline between the 2 active study medication groups compared with the placebo group in the Progressive Supranuclear Palsy Rating Scale of Golbe
Time frame: 52 weeks
8 secondary outcomes
Number of AEs and patients with an incidence rate of ≥ 5% AEs
Time frame: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Modified Schwab and England Scale
Time frame: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Timed Up and Go Test (quantitative motor function)
Time frame: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in cognitive function(Dementia Rating Scale-2,Frontal Assessment Battery,category and letter verbal fluency)
Time frame: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Starkstein Apathy Scale (behavior)
Time frame: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in functional assessments(Unified Parkinson Disease rating Scale part II and European Quality of Life questionnaire)
Time frame: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Clinical Global Impression of Change
Time frame: 52 weeks
Change from Baseline between 2 active study medication groups vs placebo group in Clinical Global Impression of Severity
Time frame: 52 weeks
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 5 Jan 2012.
- Derived from this study: PubMed 38825840Quattrone A, Franzmeier N, Huppertz HJ, Klietz M, Roemer SN, Boxer AL, Levin J, Hoglinger GU; AL-108-231 Investigators, the Tauros MRI Investigators, the PASSPORT Study Group, the DESCRIBE-PSP Group. Magnetic Resonance Imaging Measures to Track Atrophy Progression in Progressive Supranuclear Palsy in Clinical Trials. Mov Disord. 2024 Aug;39(8):1329-1342. doi: 10.1002/mds.29866. Epub 2024 Jun 2.
- Derived from this study: PubMed 28436538Hoglinger GU, Schope J, Stamelou M, Kassubek J, Del Ser T, Boxer AL, Wagenpfeil S, Huppertz HJ; AL-108-231 Investigators; Tauros MRI Investigators; Movement Disorder Society-Endorsed PSP Study Group. Longitudinal magnetic resonance imaging in progressive supranuclear palsy: A new combined score for clinical trials. Mov Disord. 2017 Jun;32(6):842-852. doi: 10.1002/mds.26973. Epub 2017 Apr 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tideglusib in people with Progressive Supranuclear Palsy, run by Noscira SA at 24 sites in 4 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 14 inclusion and 37 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 5 Jan 2012. 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 Spain, United States, Germany, 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.
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?
The change from Baseline between the 2 active study medication groups compared with the placebo group in the Progressive Supranuclear Palsy Rating Scale of Golbe (time frame: 52 weeks). 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 NCT01049399, which also lists 2 linked publications.
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 5 Jan 2012.