Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

NCT00986414 | Completed Phase 2

• 2 other identifiers: CAFQ056A2208EUDRACT number 2008-008712-98
• Study Type: interventional
• Target: 260
• Locations: 8 countries
• Sites: 47

Brief Summary

This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

Conditions

Parkinson Disease; Dyskinesias

Keywords

Parkinson Disease; L-dopa; Levodopa; dyskinesia

Outcome Measures

Primary Outcomes (1)

• Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score

  12 weeks

Secondary Outcomes (4)

• Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score

  12 weeks

• Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change

  12 weeks

• Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)

  12 weeks

• Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD

  12 weeks

Study Arms (6)

AFQ056-10mg

EXPERIMENTAL

Drug: AFQ056

AFQ056-25mg

EXPERIMENTAL

Drug: AFQ056

AFQ056-50mg

EXPERIMENTAL

Drug: AFQ056

AFQ056-75mg

EXPERIMENTAL

Drug: AFQ056

AFQ056-100mg

EXPERIMENTAL

Drug: AFQ056

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AFQ056 DRUG

AFQ056-10mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months

You may not qualify if:

• Surgical treatment for PD
• Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
• Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations

Sponsors & Collaborators

• Novartis: lead

Study Sites (47)

Novartis Investigative Site

East Gosford, 2250, Australia

Location

Novartis Investigative Site

Heidelberg, Australia

Location

Novartis Investigative Site

Melbourne, 3050, Australia

Location

Novartis Investigative Site

Parkville, 3181, Australia

Location

Novartis Investigational Site

Westmead, NSW 2145, Australia

Location

Quebec Memory & Motor Skills Disorders Clinic

Québec, Quebec, G1R 3X5, Canada

Location

Clinique Neuro-Outaouais

Gatineau, J9J 0A5, Canada

Location

Recherches Pembina, Inc

Greenfield Park, J4V 2J2, Canada

Location

Novartis Investigative Site

Montreal, H2L 4M1, Canada

Location

Parkinson's and Neurodegenerative Disorders Clinic

Ottawa, K1G 4G3, Canada

Location

Toronto Western Hospital, UHN

Toronto, M5T 2S8, Canada

Location

Novartis Investigative Site

Vancouver, V6T 2B5, Canada

Location

Novartis Investigative Site

Kuopio, Finland

Location

Novartis Investigative Site

Lahti, 15110, Finland

Location

Novartis Investigative Site

Oulu, 90220, Finland

Location

Novartis Investigative Site

Tampere, 33520, Finland

Location

Novartis Investigative Site

Turku, 20520, Finland

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

Saint-Herblain, 44800, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Beelitz-Heilstätten, 14547, Germany

Location

Novartis Investigative Site

Berlin, 13088, Germany

Location

Novartis Investigative Site

Bochum, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Kassel, 34128, Germany

Location

Novartis Investigative Site

Marburg, 35039, Germany

Location

Novartis Investigative Site

München, 80804, Germany

Location

Novartis Investigative Site

Stadtroda, 07646, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Lido di Camaiore, 55041, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Roma, 00163, Italy

Location

Novartis Investigative Site

Roma, 00185, Italy

Location

Novartis Investigative Site

Fukuoka, 814-0180, Japan

Location

Novartis Investigative Site

Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Tokyo, 113-8431, Japan

Location

Novartis Investigative Site

Tokyo, 136-0075, Japan

Location

Novartis Investigative SIte

Tokyo, 187-8551, Japan

Location

Novartis Investigative Site

Tōon, 791-0295, Japan

Location

Novartis Investigative Site

Wakayama, 641-8510, Japan

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

Novartis Investigative Site

Barcelona, 08190, Spain

Location

Novartis Investigative Site

Barcelona, Spain

Location

Novartis Investigative Site

Donostia / San Sebastian, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Related Publications (1)

• Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.

  PMID: 23853029 RESULT

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

mavoglurant

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

FI (5); FR (5); CA (7); ES (5); JP (7); AU (5); IT (4); DE (9)