Parkinson DiseasePhase 2NCT00986414
Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
A Phase 2 study testing AFQ056 in people with Parkinson Disease and Dyskinesias, run by Novartis at 47 sites in 8 countries.
Trial summary
This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease, Dyskinesias
- What is being tested?
- AFQ056
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 47 sitesin 8 countries
- Study dates
- Sep 2009to Dec 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
Who cannot join
- Surgical treatment for PD
- Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
- Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
47 sites in 8 countries.
47 sites in 8 countries
Germany9 sites
Novartis Investigative Site
Beelitz-Heilstätten, 14547
Novartis Investigative Site
Berlin, 13088
Novartis Investigative Site
Bochum
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Kassel, 34128
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
München, 80804
Novartis Investigative Site
Stadtroda, 07646
Novartis Investigative Site
Tübingen, 72076
Canada7 sites
Clinique Neuro-Outaouais
Gatineau, J9J 0A5
Recherches Pembina, Inc
Greenfield Park, J4V 2J2
Novartis Investigative Site
Montreal, H2L 4M1
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, K1G 4G3
Quebec Memory & Motor Skills Disorders Clinic
Québec, Quebec, G1R 3X5
Toronto Western Hospital, UHN
Toronto, M5T 2S8
Novartis Investigative Site
Vancouver, V6T 2B5
Japan7 sites
Novartis Investigative Site
Fukuoka, 814-0180
Novartis Investigative Site
Tochigi, 329-0498
Novartis Investigative Site
Tokyo, 113-8431
Novartis Investigative Site
Tokyo, 136-0075
Novartis Investigative SIte
Tokyo, 187-8551
Novartis Investigative Site
Tōon, 791-0295
Novartis Investigative Site
Wakayama, 641-8510
Australia5 sites
Novartis Investigative Site
East Gosford, 2250
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Melbourne, 3050
Novartis Investigative Site
Parkville, 3181
Novartis Investigational Site
Westmead, NSW 2145
Finland5 sites
Novartis Investigative Site
Kuopio
Novartis Investigative Site
Lahti, 15110
Novartis Investigative Site
Oulu, 90220
Novartis Investigative Site
Tampere, 33520
Novartis Investigative Site
Turku, 20520
France5 sites
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Saint-Herblain, 44800
Novartis Investigative Site
Toulouse, 31059
Spain5 sites
Novartis Investigative Site
Barcelona, 08036
Novartis Investigative Site
Barcelona, 08190
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Donostia / San Sebastian
Novartis Investigative Site
Madrid, 28034
Italy4 sites
Novartis Investigative Site
Lido di Camaiore, 55041
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Roma, 00163
Novartis Investigative Site
Roma, 00185
About this study
Official title: 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.
- Conditions
- Parkinson Disease, Dyskinesias
- Being tested
- AFQ056, Placebo
- Keywords
- Parkinson Disease, L-dopa, Levodopa, dyskinesia
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFQ056Drug
AFQ056Drug
AFQ056Drug
AFQ056Drug
AFQ056Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AFQ056-10mg | Experimental | Not described Receives: Drug: AFQ056 |
| AFQ056-25mg | Experimental | Not described Receives: Drug: AFQ056 |
| AFQ056-50mg | Experimental | Not described Receives: Drug: AFQ056 |
| AFQ056-75mg | Experimental | Not described Receives: Drug: AFQ056 |
| AFQ056-100mg | Experimental | Not described Receives: Drug: AFQ056 |
| 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.
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score
Measured: 12 weeks
Secondary outcomes (4)
Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score
Measured: 12 weeks
Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change
Measured: 12 weeks
Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)
Measured: 12 weeks
Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986414
- Sponsor's protocol ID
- CAFQ056A2208
- Other IDs
- EUDRACT number 2008-008712-98
- Status last verified
- Feb 2017
- First submitted
- 29 Sep 2009
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.
PubMed 23853029
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00986414
- Acronym / sponsor ID
- CAFQ056A2208
- Conditions
- Parkinson Disease, Dyskinesias
- Keywords
- Parkinson Disease, L-dopa, Levodopa, dyskinesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- First posted
- 30 Sep 2009 (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.
This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AFQ056-10mg | Experimental | Drug: AFQ056 |
| AFQ056-25mg | Experimental | Drug: AFQ056 |
| AFQ056-50mg | Experimental | Drug: AFQ056 |
| AFQ056-75mg | Experimental | Drug: AFQ056 |
| AFQ056-100mg | Experimental | Drug: AFQ056 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
Key exclusion criteria (4 listed)
- Surgical treatment for PD
- Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
- Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| AFQ056 | Drug | AFQ056-10mg |
| AFQ056 | Drug | AFQ056-25mg |
| AFQ056 | Drug | AFQ056-50mg |
| AFQ056 | Drug | AFQ056-75mg |
| AFQ056 | Drug | AFQ056-100mg |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score
Time frame: 12 weeks
4 secondary outcomes
Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score
Time frame: 12 weeks
Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change
Time frame: 12 weeks
Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)
Time frame: 12 weeks
Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD
Time frame: 12 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 23 Feb 2017.
- Results publication: PubMed 23853029Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
47 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFQ056 in people with Parkinson Disease and Dyskinesias, run by Novartis at 47 sites in 8 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 1 inclusion and 4 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany, Canada, Japan, Australia, Finland and 3 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?
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score (time frame: 12 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 NCT00986414, 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 23 Feb 2017.