Clinical trial NCT01491932: Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyskinesias
Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Anti-Dyskinesia Agents
Keywords: Parkinson Disease
L-dopa
Levodopa
Dyskinesia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Treatment with certain prohibited medications
* Abnormal lab values or heart abnormalities
* Pregnant or nursing women

Primary outcomes:
measure: Incidence rate of adverse events including serious adverse events
timeFrame: Monitored for the duration of the study (anticipated to be an average of 3 years)
measure: Severity of adverse events including serious adverse events
timeFrame: Monitored for the duration of the study (anticipated to be an average of 3 years)
measure: Change in vital signs from baseline to Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter.
timeFrame: Assessed at Day -14 to -3, Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
measure: Changes in hematology/blood chemistry and urinalysis laboratory evaluations from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
timeFrame: 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
measure: Change in ECGs from baseline to Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
timeFrame: Assessed at Day -14 to -3, Day 1, (repeated if abnormalities seen), Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
measure: 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
timeFrame: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
measure: Incidence of AEs related to an exacerbation of the underlying movement disorder Parkinson's disease
timeFrame: Monitored for the duration of the study (anticipated to be an average of 3 years)
Secondary outcomes:
measure: 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.
timeFrame: Assessed at Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
measure: 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
timeFrame: Assessed at Day 1, Weeks 4, 12, Months 6, 9, 12, every 6 months thereafter
measure: 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
timeFrame: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
measure: Change in Mini Mental State Exam (MMSE) score from baseline to Months 6, 12, every 6 months thereafter
timeFrame: Assessed at Day -14 to -3, Day 1 (only if not done in the respective core study), Months 6, 12, every 6 months thereafter
measure: 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
timeFrame: Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter
measure: 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)
timeFrame: Monitored for the duration of the study (anticipated to be an average of 3 years)
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Milwaukee
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Clermont-Ferrand Cedex 1
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Beelitz-Heilstaetten
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Stadtroda
country: Germany
facility: Novartis Investigative Site
city: Westerstede/Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Kaposvár
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Sant Cugat
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: