Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

NCT01474421 | Completed Phase 2 FDA Drug

• 2 other identifiers: CAQW051A22092011-001092-39
• Study Type: interventional
• Target: 71
• Locations: 4 countries
• Sites: 24

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.

Conditions

Dyskinesias; Drug-induced

Keywords

Parkinson's disease; Dyskinesia; Movement disorders; L-dopa

Outcome Measures

Primary Outcomes (3)

• Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score

  Dyskinesia with a maximal score of 24.

  Baseline, Day 28

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score

  Anti-parkinsonian effect in PD patients.

  Baseline, Day 28

• Safety and tolerability

  Safety and tolerability of AQW051 as measured by the number of participants with adverse events, any clinically significant abnormalities in safety labs or electrocardiograms (ECGs), and relevant orthostatic changes in blood pressure

  Up to Day 42

Secondary Outcomes (5)

• Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)

  Up to Day 42

• Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33

  Up to Day 42

• Track-PD

  Up to Day 42

• CogState

  Up to Day 28

• Area under the curve (AUC[0-24hr]) of AQW051

  Day 28

Study Arms (3)

AQW051 High Dose

EXPERIMENTAL

AQW051 high dose daily given orally for 28 days.

Drug: AQW051

AQW051 Low Dose

EXPERIMENTAL

AQW051 low dose daily given orally for 28 days.

Drug: AQW051

Placebo

PLACEBO COMPARATOR

Placebo daily given orally for 28 days.

Drug: Placebo

Interventions

AQW051 DRUG

Patients will receive AQW051 in a high dose once daily orally for 28 days.

AQW051 High Dose

Placebo DRUG

Patients will receive placebo once daily orally for 28 days.

Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (24)

Novartis Investigative Site

Sacramento, California, 95817, United States

Location

Novartis Investigative Site

Manhasset, New York, 11030, United States

Location

Novartis Investigative Site

Cincinnati, Ohio, 45219, United States

Location

Novartis Investigative Site

Cleveland, Ohio, 44195, United States

Location

Novartis Investigative Site

Bron, 69677, France

Location

Novartis Investigative Site

Clermont Fd, 63003, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Marseille, 13385, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Nantes, 44093, France

Location

Novartis Investigative Site

Paris, 75013, France

Location

Novartis Investigative Site

Pessac, 33604, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Strasbourg, 67098, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Berlin, 10178, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Gera, 07551, Germany

Location

Novartis Investigative Site

Haag, 83527, 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

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Roma, RM, 00163, Italy

Location

Related Publications (1)

• 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.

  PMID: 26990766 RESULT

Related Links

• Results for CAQW051A2209 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Dyskinesias; Parkinson Disease; Movement Disorders

Interventions

3-(6-p-tolylpyridin-3-yloxy)-1-azabicyclo(2.2.2)octane

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: November 18, 2011
• Study Start: September 15, 2011
• Primary Completion: February 21, 2013
• Study Completion: February 21, 2013
• Last Updated: December 24, 2020

Record last verified: 2017-05

Locations

DE (8); US (4); FR (11); IT (1)