DyskinesiasPhase 2NCT01385592
Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
A Phase 2 study testing AFQ056 in people with Dyskinesias and Parkinson Disease, run by Novartis Pharmaceuticals at 28 sites in 7 countries.
Trial summary
This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID) Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Dyskinesias, Parkinson Disease, Movement Disorders
- What is being tested?
- AFQ056
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 28 sitesin 7 countries
- Study dates
- Nov 2011to Sep 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 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
- Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks
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) or evidence of dementia that may interfere with the study outcome evaluations
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
Germany10 sites
Novartis Investigative Site
Beelitz-Heilstätten, 14547
Novartis Investigative Site
Berlin, 12163
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Kassel, 34128
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
München, 80804
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Stadtroda, 07646
Novartis Investigative Site
Westerstede/Oldenburg, 26655
France4 sites
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Poitiers, 86021
Spain4 sites
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Donostia / San Sebastian, 20014
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Sant Cugat del Vallès, Barcelona, 08190
Hungary3 sites
Novartis Investigative Site
Budapest, 1085
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Szeged, H-6725
Italy3 sites
Novartis Investigative Site
Bolzano, BZ, 39100
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Roma, RM, 00163
United States2 sites
Novartis Investigative Site
Englewood, Colorado, 80113
Novartis Investigative Site
Sunnyvale, California, 94089
Canada2 sites
Novartis Investigative Site
Gatineau, Quebec, J9J 0A5
Novartis Investigative Site
London, Ontario, N6A 4G5
About this study
Official title: 12-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 study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
- Being tested
- AFQ056, Placebo
- Keywords
- Parkinson Disease, L-dopa, Levodopa, Dyskinesia, Anti-Dyskinesia Agents
- Medical subject headings
- Dyskinesias, Parkinson Disease, Movement Disorders, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFQ056Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AFQ056 100 mg | 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.
Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile
Measured: 12 weeks
Secondary outcomes (5)
Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)
Measured: 12 weeks
Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)
Measured: 12 weeks
Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)
Measured: 12 weeks
Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )
Measured: 12 weeks
Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events
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 Jun 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
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 DyskinesiasStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385592
- Sponsor's protocol ID
- CAFQ056A2222
- Other IDs
- 2011-002073-30
- Status last verified
- Mar 2016
- First submitted
- 28 Jun 2011
- Last updated
- 23 Dec 2020
- Results posted
- No
Publications
Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.
PubMed 27214258
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-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
- NCT01385592
- Acronym / sponsor ID
- CAFQ056A2222
- Keywords
- Parkinson Disease, L-dopa, Levodopa, Dyskinesia, Anti-Dyskinesia Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Jun 2011 (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 study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFQ056 100 mg | 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 (2 listed)
- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
- Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks
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) or evidence of dementia 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 100 mg |
| Placebo | Drug | Placebo |
Primary outcome
Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile
Time frame: 12 weeks
5 secondary outcomes
Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)
Time frame: 12 weeks
Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)
Time frame: 12 weeks
Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)
Time frame: 12 weeks
Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )
Time frame: 12 weeks
Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events
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 Dec 2020.
- Derived from this study: PubMed 27214258Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.
- Results for CAFQ056A2222 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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
28 sites in 7 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 Dyskinesias and Parkinson Disease, run by Novartis Pharmaceuticals at 28 sites in 7 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 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 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, France, Spain, Hungary, Italy and 2 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?
Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile (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 NCT01385592, 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 Dec 2020.