Parkinson's DiseasePhase 2NCT01092065
Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia
A Phase 2 study testing AFQ056 with L-dopa in people with Parkinson's Disease, run by Novartis at 4 sites in United States.
Trial summary
This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- AFQ056 with L-dopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2010to Jul 2011
- 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 OFF time and 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
4 sites in 1 country.
United States4 sites
Colorado Neurological Institute
Englewood, Colorado, 80113
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Kansas Medical Center - Parkinson's Disease and Movement Disorders Center
Kansas City, Kansas, 66160
The Parkinsons Institute
Sunnyvale, California, 94085
About this study
Official title: A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia
This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.
- Conditions
- Parkinson's Disease
- Being tested
- AFQ056 with L-dopa, Placebo
- Keywords
- Parkinson's Disease, Dyskinesia, Drug-induced, Levodopa, L-dopa
- 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.
AFQ056 with L-dopaDrug
hard gelatin capsule to be taken bid for six weeks
PlaceboDrug
hard gelatin capsule to be taken bid for six weeks
| Study group | Role | What they receive |
|---|---|---|
| AFQ056 100 mg (Bid) | Experimental | Not described Receives: Drug: AFQ056 with L-dopa |
| 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 the last-observation-carried-forward (LOCF) endpoint at week 5 in total OFF time collected from the Hauser et al. patient diary
Measured: 5 weeks
Secondary outcomes (5)
Change from baseline to the LOCF endpoint at week 5 in ON time with dyskinesia collected from the Hauser et al. patient diary.
Measured: 5 weeks
Effect of increasing L-dopa doses on the underlying symptoms of Parkinson's Disease (PD) as measured by the United Parkinson's Disease Rating Scale (UPDRS) Part III.
Measured: 5 weeks
Change in dyskinesia from baseline to the LOCF endpoint at week 5 as measured by the modified Abnormal Involuntary Movement Scale (AIMS), patient diary and Unified Dyskinesia Rating Scale (UDysRS) Parts I-IV.
Measured: 5 weeks
Change from baseline on patient's dyskinesia, disability caused by dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change.
Measured: 5 weeks
Safety and tolerability as measured by changes in vital signs, laboratory values, ECGs, and percentages of treatment-emergent AEs and SAEs
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
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
- 23 participants (actual)
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
- NCT01092065
- Sponsor's protocol ID
- CAFQ056A2216
- Status last verified
- Mar 2013
- First submitted
- 22 Mar 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
- A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia
- ClinicalTrials.gov ID
- NCT01092065
- Acronym / sponsor ID
- CAFQ056A2216
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Dyskinesia, Drug-induced, Levodopa, L-dopa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Mar 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.
This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.
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 (Bid) | Experimental | Drug: AFQ056 with L-dopa |
| 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 OFF time and 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 with L-dopahard gelatin capsule to be taken bid for six weeks | Drug | AFQ056 100 mg (Bid) |
| Placebohard gelatin capsule to be taken bid for six weeks | Drug | Placebo |
Primary outcome
Change from baseline to the last-observation-carried-forward (LOCF) endpoint at week 5 in total OFF time collected from the Hauser et al. patient diary
Time frame: 5 weeks
5 secondary outcomes
Change from baseline to the LOCF endpoint at week 5 in ON time with dyskinesia collected from the Hauser et al. patient diary.
Time frame: 5 weeks
Effect of increasing L-dopa doses on the underlying symptoms of Parkinson's Disease (PD) as measured by the United Parkinson's Disease Rating Scale (UPDRS) Part III.
Time frame: 5 weeks
Change in dyskinesia from baseline to the LOCF endpoint at week 5 as measured by the modified Abnormal Involuntary Movement Scale (AIMS), patient diary and Unified Dyskinesia Rating Scale (UDysRS) Parts I-IV.
Time frame: 5 weeks
Change from baseline on patient's dyskinesia, disability caused by 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: 5 weeks
Safety and tolerability as measured by changes in vital signs, laboratory values, ECGs, and percentages of treatment-emergent AEs and SAEs
Time frame: 5 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.
- Results for CAFQ056A2216 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFQ056 with L-dopa in people with Parkinson's Disease, run by Novartis at 4 sites in United States.
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 4 sites in United States. 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 the last-observation-carried-forward (LOCF) endpoint at week 5 in total OFF time collected from the Hauser et al. patient diary (time frame: 5 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 23 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.