Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

NCT01491932 | Completed Phase 2

• 2 other identifiers: CAFQ056A22992011-004378-27
• Study Type: interventional
• Target: 129
• Locations: 10 countries
• Sites: 32

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).

Conditions

Dyskinesias; Parkinson Disease; Movement Disorders; Parkinsonian Disorders; Anti-Dyskinesia Agents

Keywords

Parkinson Disease; L-dopa; Levodopa; Dyskinesia

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter

Study Arms (1)

AFQ056

EXPERIMENTAL

Patients entering the study will be titrated to target dose of AFQ056 twice daily or the highest tolerated dose at weekly intervals.

Drug: AFQ056

Interventions

AFQ056 DRUG

AFQ056 will be supplied as oral capsules.

AFQ056

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (32)

Novartis Investigative Site

Englewood, Colorado, 80113, United States

Location

Novartis Investigative Site

Kansas City, Kansas, 66160, United States

Location

Novartis Investigative Site

Milwaukee, Wisconsin, 53233, United States

Location

Novartis Investigative Site

Innsbruck, A-6020, Austria

Location

Novartis Investigative Site

Linz, A-4020, Austria

Location

Novartis Investigative Site

Vienna, A-1220, Austria

Location

Novartis Investigative Site

London, Ontario, N6A 4G5, Canada

Location

Novartis Investigative Site

Clermont-Ferrand, 63003, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Pessac, 33604, France

Location

Novartis Investigative Site

Beelitz-Heilstätten, 14547, Germany

Location

Novartis Investigative Site

Berlin, 12163, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Kassel, 34128, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Stadtroda, 07646, Germany

Location

Novartis Investigative Site

Westerstede/Oldenburg, 26655, Germany

Location

Novartis Investigative Site

Kaposvár, 7400, Hungary

Location

Novartis Investigative Site

Szeged, H-6725, Hungary

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Pisa, PI, 56126, Italy

Location

Novartis Investigative Site

Roma, RM, 00163, Italy

Location

Novartis Investigative Site

Roma, RM, 00179, Italy

Location

Novartis Investigative Site

Bratislava, 82606, Slovakia

Location

Novartis Investigative Site

Bratislava, 83305, Slovakia

Location

Novartis Investigative Site

Donostia / San Sebastian, Basque Country, 20014, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Sant Cugat del Vallès, Catalonia, 08190, Spain

Location

Novartis Investigative Site

Barcelona, 08025, Spain

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Related Links

• Results from CAFQ056A2299 from the Novartis Clinical Trial Results website

MeSH Terms

Conditions

Dyskinesias; Parkinson Disease; Movement Disorders; Parkinsonian Disorders

Interventions

mavoglurant

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 14, 2011
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 23, 2020

Record last verified: 2017-03

Locations

AU (3); DE (8); CA (1); HU (2); US (3); IT (4); FR (3); SL (2); ES (5); CH (1)