Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01491529
• Date of registration: 12/12/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
• Scientific 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
• Date of first enrolment: April 2012
• Target sample size: 154
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01491529
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Canada, France, Germany, Hungary, Italy, Slovakia, Spain, Switzerland, Turkey, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinsonian Disorders

Anti-Dyskinesia Agents

Movement Disorders

Dyskinesias

Parkinson Disease

Intervention(s)

Drug: AFQ056

Drug: Placebo

Primary Outcome(s)

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]

Change in modified AIMS (Abnormal Involuntary Movement Scale) total score from baseline to Week 12 [Time Frame: 12 weeks]

The incidence rate of adverse events [Time Frame: Monitored for the duration of the study which is 13 weeks]

The percentage of patients discontinued during the up titration period due to AE [Time Frame: Assessed during the up titration period of 6 weeks]

Time to onset of adverse events [Time Frame: Monitored for the duration of the study which is 13 weeks]

Secondary Outcome(s)

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) scores from baseline to Week 12 [Time Frame: 12 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]

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 Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) total score from baseline to Week 12 [Time Frame: 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]

Change in Mini Mental State Exam (MMSE) total scores from baseline 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]

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]

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]

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]

Change in clinician-rated global impression of change (CGIC) score from baseline to Week 12 [Time Frame: 12 weeks]

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 cognitive test battery (CogState) scores form baseline to Week 12 [Time Frame: 12 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]

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]

Investigate the safety of concomitant administration of AFQ056 with amantadine [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]

Secondary ID(s)

2011-002074-23

CAFQ056A2223

Source(s) of Monetary Support

Please refer to primary and secondary sponsors