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

Primary Purpose

Dyskinesias, Drug-induced

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AQW051

Placebo

About this trial

This is an interventional treatment trial for Dyskinesias focused on measuring Parkinson's disease, Dyskinesia, Movement disorders, L-dopa

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

AQW051 High Dose

AQW051 Low Dose

Placebo

Arm Description

AQW051 high dose daily given orally for 28 days.

AQW051 low dose daily given orally for 28 days.

Placebo daily given orally for 28 days.

Outcomes

Primary Outcome Measures

Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score

Dyskinesia with a maximal score of 24.

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

Anti-parkinsonian effect in PD patients.

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

Secondary Outcome Measures

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

Assesses the degree to which dyskinesia interferes with five activities of daily living, with a higher score indicating more severe impairment.

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

Dyskinesias as a percentage of the day, and disability due to dyskinesia during the previous week.

Track-PD

Objective measures of motor function.

CogState

Cognitive function, including simple and choice reaction time, episodic visual and verbal memory, working memory, planning and strategy, and executive function.

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

Full Information

NCT ID

NCT01474421

First Posted

October 5, 2011

Last Updated

December 16, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01474421

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 15, 2011 (Actual)

Primary Completion Date

February 21, 2013 (Actual)

Study Completion Date

February 21, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyskinesias, Drug-induced

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AQW051 High Dose

Arm Type

Experimental

Arm Description

AQW051 high dose daily given orally for 28 days.

Arm Title

AQW051 Low Dose

Arm Type

Experimental

Arm Description

AQW051 low dose daily given orally for 28 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo daily given orally for 28 days.

Intervention Type

Drug

Intervention Name(s)

AQW051

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AQW051

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Patients will receive placebo once daily orally for 28 days.

Primary Outcome Measure Information:

Title

Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score

Description

Dyskinesia with a maximal score of 24.

Time Frame

Baseline, Day 28

Title

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

Description

Anti-parkinsonian effect in PD patients.

Time Frame

Baseline, Day 28

Title

Safety and tolerability

Description

Time Frame

Up to Day 42

Secondary Outcome Measure Information:

Title

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

Description

Assesses the degree to which dyskinesia interferes with five activities of daily living, with a higher score indicating more severe impairment.

Time Frame

Up to Day 42

Title

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

Description

Dyskinesias as a percentage of the day, and disability due to dyskinesia during the previous week.

Time Frame

Up to Day 42

Title

Track-PD

Description

Objective measures of motor function.

Time Frame

Up to Day 42

Title

CogState

Description

Cognitive function, including simple and choice reaction time, episodic visual and verbal memory, working memory, planning and strategy, and executive function.

Time Frame

Up to Day 28

Title

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

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Novartis Investigative Site

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Novartis Investigative Site

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

Novartis Investigative Site

City

Clermont Fd

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Marseille cedex 05

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Novartis Investigative Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10178

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Gera

ZIP/Postal Code

07551

Country

Germany

Facility Name

Novartis Investigative Site

City

Haag

ZIP/Postal Code

83527

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34128

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80804

Country

Germany

Facility Name

Novartis Investigative Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00163

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

26990766

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.

Results Reference

result

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10163

Description

Results for CAQW051A2209 from the Novartis Clinical Trials Website

Learn more about this trial

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

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

Dyskinesias, Drug-induced

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial