Clinical trial NCT01474421: Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
Official title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyskinesias
Drug-induced
Keywords: Parkinson's disease
Dyskinesia
Movement disorders
L-dopa
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's disease
* Patients with dyskinesias for at least 3 months
* Patients with moderate to severe dyskinesias
* Patients on L-dopa treatment for at least 3 years

Exclusion Criteria:

* Patients with atypical Parkinson's disease
* Patients who have had prior surgery for Parkinson's disease
* Patients who are cognitively impaired, have psychosis, have confusional states or hallucinate
* Patients who received neuroleptics or anti-psychotics within 2 months
* Women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score
timeFrame: Baseline, Day 28
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score
timeFrame: Baseline, Day 28
measure: Safety and tolerability
timeFrame: Up to Day 42
Secondary outcomes:
measure: Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)
timeFrame: Up to Day 42
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33
timeFrame: Up to Day 42
measure: Track-PD
timeFrame: Up to Day 42
measure: CogState
timeFrame: Up to Day 28
measure: Area under the curve (AUC[0-24hr]) of AQW051
timeFrame: Day 28
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Manhasset
country: United States
facility: Novartis Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Bron
country: France
facility: Novartis Investigative Site
city: Clermont Fd
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Marseille cedex 05
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Nantes Cedex 1
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse cedex 9
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Haag
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Trenkwalder C, Berg D, Rascol O, Eggert K, Ceballos-Baumann A, Corvol JC, Storch A, Zhang L, Azulay JP, Broussolle E, Defebvre L, Geny C, Gostkowski M, Stocchi F, Tranchant C, Derkinderen P, Durif F, Espay AJ, Feigin A, Houeto JL, Schwarz J, Di Paolo T, Feuerbach D, Hockey HU, Jaeger J, Jakab A, Johns D, Linazasoro G, Maruff P, Rozenberg I, Sovago J, Weiss M, Gomez-Mancilla B. A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Mov Disord. 2016 Jul;31(7):1049-54. doi: 10.1002/mds.26569. Epub 2016 Mar 15.