DyskinesiasPhase 2NCT01491529
Evaluation of the Efficacy and Safety of Modified Release 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 39 sites in 10 countries.
Trial summary
This study will assess the efficacy and safety of modified release 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 39 sitesin 10 countries
- Study dates
- Apr 2012to Apr 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females 30-80 years old
- Use of highly effective methods of contraception during study in women of childbearing potential
- Outpatients
- Clinical diagnosis of Parkinson's Disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria
- Score of >/= 2 on UPDRS items 32 and 33
- Dyskinesias for at least 3 months before baseline
Show all 10Show fewer
- On stable treatment regimen with L-dopa and other anti-parkinsonian treatment for 4 weeks prior to baseline
- Demonstrate capacity to complete accurate diary ratings
- Patients who have a primary caregiver willing to assess the condition of the patient throughout the study in accordance with protocol requirements
- Group 2 only: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study
Who cannot join
- Atypical/secondary form of Parkinson's disease
- History of surgical treatment of PD, including deep brain stimulation
- A score of 5 in the "ON"- state on the Modified Hoehn and Yahr scale
- Advanced, severe, or unstable disease other than PD
- Evidence of dementia
- Treatment with certain prohibited medications
- Amantadine within 2 weeks prior to BL1 visit (applies to Group 1 only)
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
39 sites in 10 countries.
39 sites in 10 countries
Germany9 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
United States5 sites
Novartis Investigative Site
Englewood, Colorado, 80113
Novartis Investigative Site
Kansas City, Kansas, 66160
Novartis Investigative Site
Milwaukee, Wisconsin, 53233
Novartis Investigative Site
Sunnyvale, California, 94089
Novartis Investigative Site
Tampa, Florida, 33612
Italy5 sites
Novartis Investigative Site
Bolzano, BZ, 39100
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Roma, RM, 00163
Novartis Investigative Site
Roma, RM, 00179
Spain5 sites
Novartis Investigative Site
Barcelona, Catalonia, 08025
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Donostia / San Sebastian, Basque Country, 20014
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, 08190
France4 sites
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Poitiers, 86021
Austria3 sites
Novartis Investigative Site
Innsbruck, A-6020
Novartis Investigative Site
Linz, A-4020
Novartis Investigative Site
Vienna, A-1220
Hungary3 sites
Novartis Investigative Site
Budapest, 1085
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Szeged, H-6725
Slovakia2 sites
Novartis Investigative Site
Bratislava, 82606
Novartis Investigative Site
Bratislava, 83305
Switzerland2 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Lausanne, 1011
About this study
Official title: 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release 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 modified release AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
- Conditions
- Dyskinesias, Parkinson Disease, Movement Disorders, Parkinsonian Disorders, Anti-Dyskinesia Agents
- Being tested
- AFQ056, Placebo
- Keywords
- Parkinson Disease, L-dopa, Levodopa, Dyskinesia, Amantadine
- 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 modified release tablets in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.
Patients will be randomized in two groups by amantadine status.
- Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit.
- Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.)
PlaceboDrug
Placebo for AFQ056 will be supplied as oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| AFQ056 150 mg | Experimental | Patients randomized to the AFQ056 150 mg arm will receive AFQ056 oral tablets to be titrated until reaching the target dose of 150 mg twice daily. Receives: Drug: AFQ056 |
| AFQ056 200 mg | Experimental | Patients randomized to the AFQ056 200 mg arm will receive AFQ056 oral tablets to be titrated until reaching the target dose of 200 mg twice daily.
Patients will be randomized in two groups by amantadine status.
* Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit.
* Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.) Receives: Drug: AFQ056 |
| Placebo | Placebo comparator | Patients randomized to the Placebo arm will receive oral AFQ056 Placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified AIMS (Abnormal Involuntary Movement Scale) total score from baseline to Week 12
The modified AIMS is a scale used to assess dyskinesia. It focuses on six different parts of the body and rates abnormal movements from 0 (absence of dyskinesia to 4 (severe) (maximal score, 24).
Change from baseline to Week 12 will be analyzed using the mixed effect repeated measures model (MMRM) including treatment, pooled center, week, treatment by week interaction as fixed effects and baseline total score as covariate with an unstructured covariance structure.
Measured: 12 weeks
The incidence rate of adverse events
The occurrence of adverse events would be sought by non-directive questioning of the patient. Adverse events may also be detected when they are volunteered by the patient or through physical examination, laboratory test, or other assessments.
AEs will be summarized by presenting, for each treatment group the number and percentage of patients having any adverse event, having an adverse event in each system organ class and having each individual adverse event by system organ class and preferred term.
Measured: Monitored for the duration of the study which is 13 weeks
Time to onset of adverse events
The occurrence of adverse events (AEs) would be sought by non-directive questioning of the patient. Adverse events may also be detected when they are volunteered by the patient or through physical examination, laboratory test, or other assessments.
AEs will be summarized by presenting, for each treatment group the number and percentage of patients having any adverse event, having an adverse event in each system organ class and having each individual adverse event by system organ class and preferred term.
Measured: Monitored for the duration of the study which is 13 weeks
The percentage of patients reaching and maintaining the target dose during the fixed dose treatment period
Randomized patients will be up titrated to the target dose and remain on the target dose for the duration of the fixed dose treatment period.
AEs will be summarized by presenting, for each treatment group the number and percentage of patients having any adverse event, having an adverse event in each system organ class and having each individual adverse event by system organ class and preferred term.
Measured: Assessed during the fixed dose treatment period of 6 weeks
The percentage of patients discontinued during the up titration period due to AE
Patients randomized will be up titrated to the target doses at regular intervals during the up titration period.
AEs will be summarized by presenting, for each treatment group the number and percentage of patients having any adverse event, having an adverse event in each system organ class and having each individual adverse event by system organ class and preferred term.
Measured: Assessed during the up titration period of 6 weeks
Secondary outcomes (17)
The change in total score and sub-score of UDysRS Parts I, II, III, and IV from baseline to Week 12
The UDysRS captures dyskinesia and has 4 parts: I: Historical Disability of On-Dyskinesia impact (max 44 pts); II: Historical Disability of Off-Dystonia impact (max 16 pts); III: Objective Impairment dyskinesia (max 28 pts); IV: Objective Disability based on Part III activities (max 16 pts). Higher scores mean greater severity.
Change from baseline to Week 12 will be analyzed using mixed-effect repeated measure model (MMRM) including treatment, pooled center, week, treatment by week interaction as fixed effects and baseline total score as covariate with an unstructured covariance structure.
Measured: 12 weeks
Change in Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) total score from baseline to Week 12
The LFADLDS assesses the degree of dyskinesia interfering with activities of daily living. 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. A patient and caregiver version of the revised LFADLDS will be used in this study.
Change from baseline to Week 12 will be analyzed using MMRM including treatment, pooled center, week, treatment by week interaction as fixed effects and baseline total score as covariate with an unstructured covariance structure.
Measured: 12 weeks
Change in clinician-rated global impression of change (CGIC) score from baseline to Week 12
The CGIC provides investigator-rated assessment of change from baseline to assess disability due to dyskinesia. Change from baseline will be rated on a 7-point, Likert-type scale where 1 = markedly improved, 2 = moderately improved, 3 = minimally improved, 4 = unchanged, 5 = minimally worse, 6 = moderately worse, and 7 = markedly worse.
The CGIC score at week 12 last observation carried forward (LOCF) will be analyzed using analysis of covariance (ANCOVA) model with treatment group, pooled center, and baseline CGIS (Clinical Global Impression of Severity) score as factors.
Measured: 12 weeks
Change from baseline Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) to Week 12
A patient home diary developed and validated for use in PD patients will be used to record whether the patient is asleep, OFF, ON without dyskinesia, ON with troublesome dyskinesias, and ON with non-troublesome dyskinesia.
Change from baseline to Week 12 will be analyzed using MMRM including treatment, pooled center, week, treatment by week interaction as fixed effects and baseline total score as covariate with an unstructured covariance structure.
Measured: 12 weeks
Change in score for items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS ) from baseline to Week 12
UPDRS assesses the disease state of PD. Question 32 assesses length of dyskinesias in percentage of the day. Question 33 assesses disability during the previous week (not disabling, mildly disabling, moderately disabling, severely disabling, completely disabling). Question 34 assesses painfulness of dyskinesias from 0 (no painful dyskinesias) to 4 (marked).
The change will be analyzed using MMRM including treatment, pooled center, week, treatment by week interaction as fixed effects and baseline total score as covariate with an unstructured covariance structure.
Measured: 12 weeks
Changes in vital signs from baseline to each post-baseline visit
Pulse and blood pressures are taken at each visit. Vital sign data will be summarized by presenting summary statistics for change from baseline values. The incidence rates of clinically notable vital sign abnormalities will be summarized.
Measured: Monitored at regular visits throughout duration of the study which is 13 weeks
Changes in hematology/blood chemistry and urinalysis laboratory evaluations from baseline to each post-baseline visit where hematology/blood chemistry and urinalysis are collected
Standard hematology with differential; measures of coagulability: aPTT, PT/INR; standard clinical chemistry; FSH, LH, oxytocin, prolactin, TBG, TSH, and T4; urinalysis (specific gravity, protein, glucose and blood) Laboratory data will be summarized by presenting shift tables, by presenting summary statistics, change from baseline values, and incidence rates of clinically notable abnormalities summarized.
Measured: Monitored at regular visits throughout duration of the study which is 13 weeks
Changes in electrocardiogram (ECG) from baseline to each post-baseline visit where ECGs are performed
A standard 12-lead ECG will be performed. A central facility will be used for interpretation and analysis of the ECGs.
ECG intervals will be summarized by summary statistics for change from baseline values and incidence rates of clinically notable abnormalities summarized.
Measured: Monitored at regular visits throughout duration of the study which is 13 weeks
Percentage of adverse events including treatment emergent adverse events and serious adverse events
The occurrence of adverse events would be sought by non-directive questioning of the patient. Adverse events may be detected when they are volunteered by the patient or through physical examination, laboratory test, or other assessments.
Treatment-emergent adverse events (TEAEs) will be summarized by presenting, for each treatment group, the number and percentage of patients having an AE, having an AE in each system organ class and having each AE by system organ class and preferred term.
Measured: Monitored for the duration of the study which is 13 weeks
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) scores from baseline to Week 12
Part III of the UPDRS (items 18-31; score 0-56), measures 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 means worsening of symptoms.
Changes from baseline to Week 12 will be analyzed using MMRM including treatment, pooled center, week, treatment by week interaction as fixed effects and baseline total score as covariate with an unstructured covariance structure.
Measured: 12 weeks
Change in Mini Mental State Exam (MMSE) total scores from baseline to Week 12
The MMSE is a test of cognitive dysfunction consisting of 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 meaning better function.
The change from baseline to endpoint at Week 12 in MMSE total score will be analyzed using LOCF ANCOVA with treatment group and pooled center as factors and the baseline score as a covariate. Treatment differences in the change from baseline for scores with 90% CI will be reported as descriptive statistics.
Measured: 12 weeks
Change in cognitive test battery (CogState) scores form baseline to Week 12
This test consists of: Detection Task, Identification Task, One Card Learning Task, One Back Task, and International Shopping List Task. Speed times and working memory will be measured by the number of correct responses.
The change from baseline to endpoint at Week 12 for cognitive function will be analyzed using LOCF ANCOVA with treatment group and pooled center as factors and the baseline score as a covariate. Treatment differences in the change from baseline for cognitive function with 90% CI will be reported as descriptive statistics
Measured: 12 weeks
Total scores of the Scales for Outcomes in Parkinson's disease - Psychiatric Complications (SCOPA-PC)
The SCOPA-PC is an easily administered semi-structured, questionnaire developed for the assessment of psychiatric symptoms 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.
The SCOPA-PC total score and each of the item scores will be summarized.
Measured: Assessed for 12 weeks
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: This will be assessed for the duration of the study which is 13 weeks
Plasma Pharmacokinetics of AFQ056 in patients with Parkinson's disease with moderate to severe dyskinesias
Blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. The first blood sample will be collected 1-3 hours after morning study medication dose. The second sample will be collected 3-5 hours after the morning study medication dose. The third blood sample will be collected 5-7 hours after the morning study medication dose.
Summary statistics for concentrations per sampling window will be provided and average plasma levels will be calculated.
Measured: At Week 12 or earlier if the patient discontinues the study before Week 12
Pharmacokinetics of AFQ056 in patients with Parkinson's disease with moderate to severe dyskinesias
Blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. An alternative sampling method will also be explored. At all visits, the sample will be collected 1-3 hours after morning study medication dose. At Week 12, the second sample will be collected 3-5 hours after the morning study medication dose and the third sample will be collected 5-7 hours after the morning study medication dose.
Summary statistics for concentrations per sampling window will be provided and average plasma levels will be calculated.
Measured: Monitored at regular visits throughout duration of the study which is 13 weeks
Investigate the safety of concomitant administration of AFQ056 with amantadine
Investigation of the safety of AFQ056 with concomitant amantadine is being studied to gather drug-drug interaction data of amantadine and AFQ056 in this patient population.
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 posted14 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
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
- 154 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
- NCT01491529
- Sponsor's protocol ID
- CAFQ056A2223
- Other IDs
- 2011-002074-23
- Status last verified
- Mar 2016
- First submitted
- 12 Dec 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
- 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01491529
- Acronym / sponsor ID
- CAFQ056A2223
- Conditions
- Dyskinesias, Parkinson Disease, Movement Disorders, Parkinsonian Disorders, Anti-Dyskinesia Agents
- Keywords
- Parkinson Disease, L-dopa, Levodopa, Dyskinesia, Amantadine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 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 will assess the efficacy and safety of modified release 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
- 3
| Arm | Type | Receives |
|---|---|---|
| AFQ056 150 mg | Experimental | Drug: AFQ056Patients randomized to the AFQ056 150 mg arm will receive AFQ056 oral tablets to be titrated until reaching the target dose of 150 mg twice daily. |
| AFQ056 200 mg | Experimental | Drug: AFQ056Patients randomized to the AFQ056 200 mg arm will receive AFQ056 oral tablets to be titrated until reaching the target dose of 200 mg twice daily. Patients will be randomized in two groups by amantadine status. * Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit. * Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.) |
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized to the Placebo arm will receive oral AFQ056 Placebo twice daily |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and Females 30-80 years old
- Use of highly effective methods of contraception during study in women of childbearing potential
- Outpatients
- Clinical diagnosis of Parkinson's Disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria
- Score of >/= 2 on UPDRS items 32 and 33
Key exclusion criteria (8 listed)
- Atypical/secondary form of Parkinson's disease
- History of surgical treatment of PD, including deep brain stimulation
- A score of 5 in the "ON"- state on the Modified Hoehn and Yahr scale
- Advanced, severe, or unstable disease other than PD
- 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 modified release tablets in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. Patients will be randomized in two groups by amantadine status. * Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit. * Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.) | Drug | AFQ056 150 mg, AFQ056 200 mg |
| PlaceboPlacebo for AFQ056 will be supplied as oral tablets. | Drug | Placebo |
Primary outcome
Change in modified AIMS (Abnormal Involuntary Movement Scale) total score from baseline to Week 12
Time frame: 12 weeks
The modified AIMS is a scale used to assess dyskinesia. It focuses on six different parts of the body and rates abnormal movements from 0 (absence of dyskinesia to 4 (severe) (maximal score, 24). Change from baseline to Week 12 will be analyzed using the mixed effect repeated measures model (MMRM) including treatment, pooled center, week, treatment by week interaction as fixed effects and baseline total score as covariate with an unstructured covariance structure.
The incidence rate of adverse events
Time frame: Monitored for the duration of the study which is 13 weeks
The occurrence of adverse events would be sought by non-directive questioning of the patient. Adverse events may also be detected when they are volunteered by the patient or through physical examination, laboratory test, or other assessments. AEs will be summarized by presenting, for each treatment group the number and percentage of patients having any adverse event, having an adverse event in each system organ class and having each individual adverse event by system organ class and preferred term.
Time to onset of adverse events
Time frame: Monitored for the duration of the study which is 13 weeks
The occurrence of adverse events (AEs) would be sought by non-directive questioning of the patient. Adverse events may also be detected when they are volunteered by the patient or through physical examination, laboratory test, or other assessments. AEs will be summarized by presenting, for each treatment group the number and percentage of patients having any adverse event, having an adverse event in each system organ class and having each individual adverse event by system organ class and preferred term.
The percentage of patients reaching and maintaining the target dose during the fixed dose treatment period
Time frame: Assessed during the fixed dose treatment period of 6 weeks
Randomized patients will be up titrated to the target dose and remain on the target dose for the duration of the fixed dose treatment period. AEs will be summarized by presenting, for each treatment group the number and percentage of patients having any adverse event, having an adverse event in each system organ class and having each individual adverse event by system organ class and preferred term.
The percentage of patients discontinued during the up titration period due to AE
Time frame: Assessed during the up titration period of 6 weeks
Patients randomized will be up titrated to the target doses at regular intervals during the up titration period. AEs will be summarized by presenting, for each treatment group the number and percentage of patients having any adverse event, having an adverse event in each system organ class and having each individual adverse event by system organ class and preferred term.
17 secondary outcomes
The change in total score and sub-score of UDysRS Parts I, II, III, and IV from baseline to Week 12
Time frame: 12 weeks
Change in Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) total score from baseline to Week 12
Time frame: 12 weeks
Change in clinician-rated global impression of change (CGIC) score from baseline to Week 12
Time frame: 12 weeks
Change from baseline Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) to Week 12
Time frame: 12 weeks
Change in score for items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS ) from baseline to Week 12
Time frame: 12 weeks
Changes in vital signs from baseline to each post-baseline visit
Time frame: Monitored at regular visits throughout duration of the study which is 13 weeks
Changes in hematology/blood chemistry and urinalysis laboratory evaluations from baseline to each post-baseline visit where hematology/blood chemistry and urinalysis are collected
Time frame: Monitored at regular visits throughout duration of the study which is 13 weeks
Changes in electrocardiogram (ECG) from baseline to each post-baseline visit where ECGs are performed
Time frame: Monitored at regular visits throughout duration of the study which is 13 weeks
Percentage of adverse events including treatment emergent adverse events and serious adverse events
Time frame: Monitored for the duration of the study which is 13 weeks
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) scores from baseline to Week 12
Time frame: 12 weeks
Change in Mini Mental State Exam (MMSE) total scores from baseline to Week 12
Time frame: 12 weeks
Change in cognitive test battery (CogState) scores form baseline to Week 12
Time frame: 12 weeks
Total scores of the Scales for Outcomes in Parkinson's disease - Psychiatric Complications (SCOPA-PC)
Time frame: Assessed for 12 weeks
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: This will be assessed for the duration of the study which is 13 weeks
Plasma Pharmacokinetics of AFQ056 in patients with Parkinson's disease with moderate to severe dyskinesias
Time frame: At Week 12 or earlier if the patient discontinues the study before Week 12
Pharmacokinetics of AFQ056 in patients with Parkinson's disease with moderate to severe dyskinesias
Time frame: Monitored at regular visits throughout duration of the study which is 13 weeks
Investigate the safety of concomitant administration of AFQ056 with amantadine
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 CAFQ056A2223 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
39 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 39 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 10 inclusion and 8 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 39 sites in Germany, United States, Italy, Spain, France 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. 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 in modified AIMS (Abnormal Involuntary Movement Scale) total score from baseline to Week 12 (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 NCT01491529, 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.