Parkinson's DiseasePhase 2CONFIDENT-PDNCT01060878
Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
A Phase 2 study testing PYM50028 in people with Parkinson's Disease, run by Phytopharm at 111 sites in 10 countries.
Trial summary
A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- PYM50028
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- 111 sitesin 10 countries
- Study dates
- Nov 2010to Dec 2012
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
- subjects who are not currently receiving any PD treatment
Who cannot join
- female of child-bearing potential
- history of neurosurgical procedures for PD
- history of severe psychiatric illness
Trial locations and contacts
111 sites in 10 countries.
111 sites in 10 countries
United States41 sites
Emory University
Atlanta, Georgia, 30329
Medical College of Georgia
Augusta, Georgia, 30912
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Elks Rehab - Movement Disorders Center
Boise, Idaho, 83702
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29401
University of Virginia Adult Neurology
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center Neuroscience Inst.
Chicago, Illinois, 60612
University of Cincinnati Physicians
Cincinnati, Ohio, 45219
Neurological Institute, Cleveland Clinic
Cleveland, Ohio, 44195
Duke Parkinson Center
Durham, North Carolina, 27705
Colorado Neurological Institute, Rocky Mountain Movement Disorders Center
Englewood, Colorado, 80113
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
Baylor College of Medicine
Houston, Texas, 77030
University of California, Irvine
Irvine, California, 92697
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Coastal Neurological Medical Group
La Jolla, California, 92037
Cedars Sinai Medical Center
Los Angeles, California, 90048
Hartford Hospital
Manchester, Connecticut, 06040
North Shore University Hospital
Manhasset, New York, 11030
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, 53233
Atlantic Neuroscience Institute
Morristown, New Jersey, 07902
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Weil Medical College of Cornell University
New York, New York, 10021
Pacific Neuroscience
Oxnard, California, 93030
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Ellison Ambulatory Care Center
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84108
Mayo Clinic
Scottsdale, Arizona, 85259
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
Washington University School of Medicine
St Louis, Missouri, 63110
The Parkinson's Institute
Sunnyvale, California, 94085
Neurology Clinical Research Inc
Sunrise, Florida, 33351
University of South Florida
Tampa, Florida, 33606
University of Toledo
Toledo, Ohio, 43614
Henry Ford Health Center
West Bloomfield, Michigan, 48322
Germany15 sites
Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik
Bayern, 97080
Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson
Beelitz-Heilstätten, 14547
Klinik für Neurologie Charité, Universitaetsmedizin Berlin
Berlin, 13353
Ruhr-Universität Bochum
Bochum, 44791
Rheinische Friedrich-Wilhelms-Universität
Bonn, 53105
Klinikum-Bremerhaven Reinkenheide
Bremerhaven, 27574
Neurologische Universitätsklinik, Klinikum Carl Gustav Carus
Dresden, 01307
Uniklinik Freiburg
Freiburg im Breisgau, 79106
Paracelsus-Elena-Klinik
Kassel, 34128
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105
Gertrudis Klinik Biskirchen
Leun-Biskirchen, 35638
Neurologische Klinik Lübeck
Lübeck, 23558
Philipps-Universität Marburg
Marburg, 35039
Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen
Munich, 81675
Universitätsklinikum Tübingen (UKT)
Tübingen, 72076
United Kingdom14 sites
Fairfield General Hospital
Bury, BL9 7TD
West Suffolk Hospitals NHS Trust
Bury Saint Edmonds, Suffolk, IP33 2QZ
Cambridge Centre for Brain Repair
Cambridge, Cambridgeshire, CB2 0PY
The Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW
Southern General Hospital
Glasgow, G51 4TF
Walton Centre for Neurology and Neurosurgery
Liverpool, L9 7LJ
Royal Free Hospital
London, NW3 2QG
King's College Hospital
London, SE5 9RS
Charing Cross Hospital
London, W6 8RF
Luton and Dunstable Hospital Foundation Trust
Luton, Bedfordshire, LU4 0DZ
Clinical Ageing Research Unit
Newcastle upon Tyne, Tyne and Wear, NE4 5PL
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8BX
Salford Royal Foundation Trust
Salford, M6 8HD
Hungary11 sites
Semmelweis Egyetem AOK Neurologiai Klinika
Budapest, 1083
Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly
Budapest, 1145
Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly
Budapest, 1204
De Oec Áok
Debrecen, 4032
Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly
Debrecen, 4043
Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly
Győr, 9023
Kaposi Mór Oktató Kórház
Kaposvár, 7400
Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly
Kecskemét, 6000
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika
Szeged, 6722
Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya
Veszprém, 8200
Zala Megyei Korhaz Neurologiai Osztaly
Zalaegerszeg, 8900
Canada8 sites
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Clinique Neuro-Outaouais
Gatineau, Quebec, J9J 0A5
London Health Science Centre
London, Ontario, N6A 5A5
Parkinsons Neurodegenerative Disorder Clinic
Ottawa, Ontario, K1G 3G4
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
Clinique Sainte-Anne "Memoire et mouvement"
Québec, Quebec, G1S 2M5
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Czechia5 sites
Fakultni nemocnice Hradec Kralove Neurologicka klinika
Hradec Králové, 500 05
Fakultni nemocnice Olomouc Neurologicka klinika
Olomouc, 799 00
Fakultní nemocnice Královské Vinohrady
Prague, 100 34
Clintrial s.r.o.
Prague, 108 00
Vseobecna fakultni nemocnice v Praze Neurologicka klinika
Prague, 128 21
Poland5 sites
NZOZ Medica Pro Familia Sp z o o
Katowice, 40-040
Małopolskie Centrum Medyczne
Krakow, 30-510
Krakowska Akademia Neurologii Sp z o o
Krakow, 31-505
prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski
Lodz, 90-130
NZOZ Medica Pro Familia Sp z o o
Warsaw, 01-868
Romania5 sites
Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril
Brasov, 500387
Spitalul Clinic de Recuperare Cluj-Napoca
Cluj-Napoca, 400437
Spitalul Clinic Cai Ferate Constanta
Constanța, 900123
Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi
Iași, 700903
Spitalul Clinic Judetean de Urgenta Timisoara
Timișoara, 300736
Serbia4 sites
Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju
Belgrade, 11000
Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju
Belgrade, 11000
Klinički centar Srbije
Belgrade, 11000
Kliničko-bolnički centar
Belgrade, 11000
France3 sites
Centre Hospitalier Henri Mondor
Créteil, 94010
CHRU de Lille
Lille, 59037
CHU de Toulouse - Hôpital Purpan
Toulouse, 31059
About this study
Official title: Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks
A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.
- Conditions
- Parkinson's Disease
- Being tested
- PYM50028, Placebo
- Keywords
- Early-stage
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYM50028Drug
IMP
PlaceboDrug
Matching placebo comprising identical vehicle to active doses
| Study group | Role | What they receive |
|---|---|---|
| Dose I | Experimental | Not described Receives: Drug: PYM50028 |
| Dose II | Experimental | Not described Receives: Drug: PYM50028 |
| Dose III | Experimental | Not described Receives: Drug: PYM50028 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale parts II & III combined score
Measured: 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phytopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060878
- Sponsor's protocol ID
- P58/07CL/ST/09/02
- Acronym
- CONFIDENT-PD
- Status last verified
- Mar 2013
- First submitted
- 1 Feb 2010
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks
- ClinicalTrials.gov ID
- NCT01060878
- Acronym / sponsor ID
- CONFIDENT-PD / P58/07CL/ST/09/02
- Conditions
- Parkinson's Disease
- Keywords
- Early-stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- PhytopharmIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Feb 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.
A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose I | Experimental | Drug: PYM50028 |
| Dose II | Experimental | Drug: PYM50028 |
| Dose III | Experimental | Drug: PYM50028 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
- subjects who are not currently receiving any PD treatment
Key exclusion criteria (3 listed)
- female of child-bearing potential
- history of neurosurgical procedures for PD
- history of severe psychiatric illness
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 |
|---|---|---|
| PYM50028IMP | Drug | Dose I, Dose II, Dose III |
| PlaceboMatching placebo comprising identical vehicle to active doses | Drug | Placebo |
Primary outcome
Unified Parkinson's Disease Rating Scale parts II & III combined score
Time frame: 28 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 4 Mar 2013.
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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.
111 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PYM50028 in people with Parkinson's Disease, run by Phytopharm at 111 sites in 10 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 2 inclusion and 3 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 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United States, Germany, United Kingdom, Hungary, Canada and 5 more countries. 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?
Unified Parkinson's Disease Rating Scale parts II & III combined score (time frame: 28 Weeks). 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 4 Mar 2013.