DyskinesiasPhase 2NCT01491932
Open-label, Long-term Safety Extension Study 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 32 sites in 10 countries.
Trial summary
This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyskinesias, Parkinson Disease, Movement Disorders
- What is being tested?
- AFQ056
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 32 sitesin 10 countries
- Study dates
- Mar 2012to 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
- Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol
- Outpatients
- Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements
Who cannot join
- Atypical or secondary form of Parkinson's disease
- History of surgical treatment for PD including deep brain stimulation
- Advanced, severe, or unstable disease (other than PD)
- History of malignancy
- Evidence of dementia
- Untreated/ineffectively treated mental disorders
Show all 9Show fewer
- Treatment with certain prohibited medications
- Abnormal lab values or heart abnormalities
- Pregnant or nursing women
Trial locations and contacts
32 sites in 10 countries.
32 sites in 10 countries
Germany8 sites
Novartis Investigative Site
Beelitz-Heilstätten, 14547
Novartis Investigative Site
Berlin, 12163
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Kassel, 34128
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Stadtroda, 07646
Novartis Investigative Site
Westerstede/Oldenburg, 26655
Spain5 sites
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Donostia / San Sebastian, Basque Country, 20014
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, 08190
Italy4 sites
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Roma, RM, 00163
Novartis Investigative Site
Roma, RM, 00179
United States3 sites
Novartis Investigative Site
Englewood, Colorado, 80113
Novartis Investigative Site
Kansas City, Kansas, 66160
Novartis Investigative Site
Milwaukee, Wisconsin, 53233
Austria3 sites
Novartis Investigative Site
Innsbruck, A-6020
Novartis Investigative Site
Linz, A-4020
Novartis Investigative Site
Vienna, A-1220
France3 sites
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Pessac, 33604
Hungary2 sites
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Szeged, H-6725
Slovakia2 sites
Novartis Investigative Site
Bratislava, 82606
Novartis Investigative Site
Bratislava, 83305
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
This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).
- Conditions
- Dyskinesias, Parkinson Disease, Movement Disorders, Parkinsonian Disorders, Anti-Dyskinesia Agents
- Being tested
- AFQ056
- Keywords
- Parkinson Disease, L-dopa, Levodopa, Dyskinesia
- 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
AFQ056 will be supplied as oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| AFQ056 | Experimental | Patients entering the study will be titrated to target dose of AFQ056 twice daily or the highest tolerated dose at weekly intervals. Receives: Drug: AFQ056 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse events including serious adverse events
The occurrence of adverse events would be sought by non-directive questioning of the patient at each visit. Adverse events may also be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessment.
Measured: Monitored for the duration of the study (anticipated to be an average of 3 years)
Severity of adverse events including serious adverse events
The occurrence and severity of adverse events would be sought by non-directive questioning of the patient at each visit. Adverse events may also be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessment.
Measured: Monitored for the duration of the study (anticipated to be an average of 3 years)
Change in vital signs from baseline to Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter.
Pulse and blood pressure at each visit as indicated above. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Measured: Assessed at Day -14 to -3, Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Changes in hematology/blood chemistry and urinalysis laboratory evaluations from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Standard hematology with differential, aPTT, PT/INR;, clinical chemistry consists of albumin, alkaline phosphatase, amylase, total bilirubin, calcium, cholesterol, creatinine, CK, γ-GT, glucose, lipase, lactate dehydrogenase, inorganic phosphorus, magnesium, potassium, total protein, AST, ALT, sodium, triglycerides, urea and uric acid, FSH, LH, oxytocin, prolactin, TBG, TSH, and T4; urinalysis (specific gravity, protein, glucose and blood) If a patient discontinues in between these visits, these will be assessed at the time of discontinuation.
Measured: Assessed at Day -14 to -3, Day 1(only urinalysis and only done if abnormalities), Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Change in ECGs from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
A standard 12-lead ECG will be performed. A central facility will be used for interpretation and analysis of the ECGs. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Measured: Assessed at Day -14 to -3, Day 1, (repeated if abnormalities seen), Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III scores from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Part III of the UPDRS (items 18-31; total score 0-56), has been proven to be a reliable instrument in assessing the anti-parkinsonian effect in PD patients. This scale measures 14 items such as speech, facial expression, tremor, action or postural tremor, rigidity, finger taps, hand movement, alternating movement, leg agility, arising from a chair, posture, gait, postural stability, and bradykinesia. A higher score is indicative of worsening of symptoms. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Measured: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Incidence of AEs related to an exacerbation of the underlying movement disorder Parkinson's disease
The occurrence of adverse events relating to the underlying movement disorder Parkinson's disease would be sought by non-directive questioning of the patient at each visit. Adverse events may also be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessment.
Measured: Monitored for the duration of the study (anticipated to be an average of 3 years)
Secondary outcomes (6)
Change in mAIMS (modified Abnormal Involuntary Movement Scale) total score from baseline to Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter.
The AIMS is a scale for assessing dyskinesia. The modified version of this scale used in this study focuses on 6 different parts of the body and rates abnormal movements from 0 (absence of dyskinesia) to 4 (severe) (maximal score, 24). If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Measured: Assessed at Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Change in Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) scores (patient and caregiver versions) from baseline to Weeks 4, 12, Months 6, 9, 12, every 6 months thereafter
The LFADLDS is a questionnaire asking the patient about the degree to which dyskinesia interferes with activities of daily living. The LFADLDS is modified from the ADL section of the UPRDS (part II). Specific definitions for severity rating codes (range, 0-4 for each task) will be provided for reproducibility of results. A higher score indicates more severe impairment. Two versions of the revised LFADLDS will be used in this study: a patient version and a caregiver version. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Measured: Assessed at Day 1, Weeks 4, 12, Months 6, 9, 12, every 6 months thereafter
Change in score for items 32, 33, and 34 of Part IV of the UPDRS from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
The UPDRS is a standardized instrument for measuring the disease state of PD patients.
Question 32 assesses duration of dyskinesias expressed in percentage of the day . Question 33 makes a historical assessment of disability due to dyskinesia during the previous week (not disabling, mildly disabling, moderately disabling, severely disabling, completely disabling).
Question 34 of part IV assesses how painful the dyskinesias are from 0 (no painful dyskinesias) to 4 (marked). If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Measured: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Change in Mini Mental State Exam (MMSE) score from baseline to Months 6, 12, every 6 months thereafter
The MMSE is a brief test of cognitive dysfunction consisting of five sections (orientation, registration, attention-calculation, recall, and language) administered by a health care professional. The MMSE results in total possible score of 30, with higher scores indicating better function. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Measured: Assessed at Day -14 to -3, Day 1 (only if not done in the respective core study), Months 6, 12, every 6 months thereafter
Change in the Scales for outcomes in Parkinson's disease - Psychiatric Complications (SCOPA-PC) score from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
The SCOPA-PC is an easily administered semi-structured, questionnaire developed for the assessment of psychiatric symptoms, including compulsive behavior, in Parkinson's disease patients administered by a clinician with input provided by patient and caregiver. The total SCOPA score ranges from 0-21, with higher scores reflecting more psychiatric complications. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Measured: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Proportion of patients who have suicidal ideation and behavior as mapped to Columbia Classification Algorithm for Suicide assessment (C-CASA) using data from Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS assesses suicidal ideation/behavior using a patient interview. The data is mapped to Columbia Classification Algorithm for Suicide assessment. The code and categories are: completed suicide, suicide attempt, preparatory actions toward imminent suicide behavior, suicidal ideation, self-injurious behavior without suicidal intent.
The proportion of patients who are coded in the categories above, the proportion of patients with any suicidal behavior engaged in during the study, and the proportion of patients with suicidality will be summarized.
Measured: Monitored for the duration of the study (anticipated to be an average of 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startMar 2012
- 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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 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
- NCT01491932
- Sponsor's protocol ID
- CAFQ056A2299
- Other IDs
- 2011-004378-27
- Status last verified
- Mar 2017
- First submitted
- 1 Dec 2011
- 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
- NCT01491932
- Acronym / sponsor ID
- CAFQ056A2299
- Conditions
- Dyskinesias, Parkinson Disease, Movement Disorders, Parkinsonian Disorders, Anti-Dyskinesia Agents
- Keywords
- Parkinson Disease, L-dopa, Levodopa, Dyskinesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Dec 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 is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFQ056 | Experimental | Drug: AFQ056Patients entering the study will be titrated to target dose of AFQ056 twice daily or the highest tolerated dose at weekly intervals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol
- Outpatients
- Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements
Key exclusion criteria (9 listed)
- Atypical or secondary form of Parkinson's disease
- History of surgical treatment for PD including deep brain stimulation
- Advanced, severe, or unstable disease (other than PD)
- History of malignancy
- Evidence of dementia
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 |
|---|---|---|
| AFQ056AFQ056 will be supplied as oral capsules. | Drug | AFQ056 |
Primary outcome
Incidence rate of adverse events including serious adverse events
Time frame: Monitored for the duration of the study (anticipated to be an average of 3 years)
The occurrence of adverse events would be sought by non-directive questioning of the patient at each visit. Adverse events may also be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessment.
Severity of adverse events including serious adverse events
Time frame: Monitored for the duration of the study (anticipated to be an average of 3 years)
The occurrence and severity of adverse events would be sought by non-directive questioning of the patient at each visit. Adverse events may also be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessment.
Change in vital signs from baseline to Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter.
Time frame: Assessed at Day -14 to -3, Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Pulse and blood pressure at each visit as indicated above. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Changes in hematology/blood chemistry and urinalysis laboratory evaluations from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Time frame: Assessed at Day -14 to -3, Day 1(only urinalysis and only done if abnormalities), Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Standard hematology with differential, aPTT, PT/INR;, clinical chemistry consists of albumin, alkaline phosphatase, amylase, total bilirubin, calcium, cholesterol, creatinine, CK, γ-GT, glucose, lipase, lactate dehydrogenase, inorganic phosphorus, magnesium, potassium, total protein, AST, ALT, sodium, triglycerides, urea and uric acid, FSH, LH, oxytocin, prolactin, TBG, TSH, and T4; urinalysis (specific gravity, protein, glucose and blood) If a patient discontinues in between these visits, these will be assessed at the time of discontinuation.
Change in ECGs from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Time frame: Assessed at Day -14 to -3, Day 1, (repeated if abnormalities seen), Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
A standard 12-lead ECG will be performed. A central facility will be used for interpretation and analysis of the ECGs. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III scores from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Time frame: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Part III of the UPDRS (items 18-31; total score 0-56), has been proven to be a reliable instrument in assessing the anti-parkinsonian effect in PD patients. This scale measures 14 items such as speech, facial expression, tremor, action or postural tremor, rigidity, finger taps, hand movement, alternating movement, leg agility, arising from a chair, posture, gait, postural stability, and bradykinesia. A higher score is indicative of worsening of symptoms. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
Incidence of AEs related to an exacerbation of the underlying movement disorder Parkinson's disease
Time frame: Monitored for the duration of the study (anticipated to be an average of 3 years)
The occurrence of adverse events relating to the underlying movement disorder Parkinson's disease would be sought by non-directive questioning of the patient at each visit. Adverse events may also be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessment.
6 secondary outcomes
Change in mAIMS (modified Abnormal Involuntary Movement Scale) total score from baseline to Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter.
Time frame: Assessed at Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Change in Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) scores (patient and caregiver versions) from baseline to Weeks 4, 12, Months 6, 9, 12, every 6 months thereafter
Time frame: Assessed at Day 1, Weeks 4, 12, Months 6, 9, 12, every 6 months thereafter
Change in score for items 32, 33, and 34 of Part IV of the UPDRS from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Time frame: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Change in Mini Mental State Exam (MMSE) score from baseline to Months 6, 12, every 6 months thereafter
Time frame: Assessed at Day -14 to -3, Day 1 (only if not done in the respective core study), Months 6, 12, every 6 months thereafter
Change in the Scales for outcomes in Parkinson's disease - Psychiatric Complications (SCOPA-PC) score from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Time frame: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
Proportion of patients who have suicidal ideation and behavior as mapped to Columbia Classification Algorithm for Suicide assessment (C-CASA) using data from Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Monitored for the duration of the study (anticipated to be an average of 3 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 from CAFQ056A2299 from the Novartis Clinical Trial Results 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
32 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 AFQ056 in people with Dyskinesias and Parkinson Disease, run by Novartis Pharmaceuticals at 32 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 3 inclusion and 9 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 32 sites in Germany, Spain, Italy, United States, Austria 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. 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 rate of adverse events including serious adverse events (time frame: Monitored for the duration of the study (anticipated to be an average of 3 years)). The study lists 7 primary outcomes in all. 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.