Parkinson DiseasePhase 2NCT01173731
Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
A Phase 2 study testing AFQ056 in people with Parkinson Disease and Dyskinesia, Drug-Induced, run by Novartis Pharmaceuticals at 22 sites in 6 countries.
Trial summary
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Dyskinesia, Drug-Induced, Levodopa
- What is being tested?
- AFQ056
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 22 sitesin 6 countries
- Study dates
- Oct 2010to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.
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
22 sites in 6 countries.
22 sites in 6 countries
Germany7 sites
Novartis Investigative Site
Bochum, 44791
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
United States3 sites
Novartis Investigative Site
Englewood, Colorado, 80113
Novartis Investigative Site
Indianapolis, Indiana, 46202
Novartis Investigative Site
Sunnyvale, California, 94089
Australia3 sites
Novartis Investigative Site
Heidelberg, Victoria, 3081
Novartis Investigative Site
Parkville, Victoria, 3050
Novartis Investigative Site
Prahran, Victoria, 3181
Canada3 sites
Novartis Investigative Site
Gatineau, Quebec, J9J 0A5
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2J2
Novartis Investigative Site
Ottawa, Ontario, K1G 4G3
France3 sites
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Pessac, 33604
Italy3 sites
Novartis Investigative Site
Lido di Camaiore, LU, 55041
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Roma, RM, 00163
About this study
Official title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Levodopa
- Being tested
- AFQ056
- Keywords
- Parkinson Disease, L-dopa, Levodopa, Dyskinesia, involuntary movement, motor complication
- Medical subject headings
- Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFQ056Drug
| Study group | Role | What they receive |
|---|---|---|
| AFQ056 | Experimental | Not described Receives: Drug: AFQ056 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC).
Measured: 3.5 years
Secondary outcomes (2)
Assessment of dyskinetic symptoms by change from baseline in mAIMS total score
Measured: 3.5 years
Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT01173731
- Sponsor's protocol ID
- CAFQ056A2217
- Other IDs
- 2010-019418-25
- Status last verified
- Mar 2017
- First submitted
- 28 Jul 2010
- Last updated
- 23 Dec 2020
- Results posted
- No
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
- An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
- ClinicalTrials.gov ID
- NCT01173731
- Acronym / sponsor ID
- CAFQ056A2217
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Levodopa
- Keywords
- Parkinson Disease, L-dopa, Levodopa, Dyskinesia, involuntary movement, motor complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Aug 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 generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFQ056 | Experimental | Drug: AFQ056 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.
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 |
Primary outcome
Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC).
Time frame: 3.5 years
2 secondary outcomes
Assessment of dyskinetic symptoms by change from baseline in mAIMS total score
Time frame: 3.5 years
Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively
Time frame: 3.5 years
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.
- Results for CAFQ056A2217 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
22 sites in 6 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 Dyskinesia, Drug-Induced, run by Novartis Pharmaceuticals at 22 sites in 6 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 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 22 sites in Germany, United States, Australia, Canada, France and 1 more country. 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. 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?
Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC). (time frame: 3.5 years). 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 23 Dec 2020.