DyskinesiasPhase 2NCT01474421
Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
A Phase 2 study testing AQW051 in people with Dyskinesias and Drug-induced, run by Novartis Pharmaceuticals at 24 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Dyskinesias, Drug-induced
- What is being tested?
- AQW051
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 15 Sep 2011to 21 Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
France11 sites
Novartis Investigative Site
Bron, 69677
Novartis Investigative Site
Clermont Fd, 63003
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Marseille, 13385
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Poitiers, 86021
Novartis Investigative Site
Strasbourg, 67098
Novartis Investigative Site
Toulouse, 31059
Germany8 sites
Novartis Investigative Site
Berlin, 10178
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Gera, 07551
Novartis Investigative Site
Haag, 83527
Novartis Investigative Site
Kassel, 34128
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
München, 80804
Novartis Investigative Site
Tübingen, 72076
United States4 sites
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Manhasset, New York, 11030
Novartis Investigative Site
Sacramento, California, 95817
About this study
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
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
- Being tested
- AQW051, Placebo
- Keywords
- Parkinson's disease, Dyskinesia, Movement disorders, L-dopa
- Medical subject headings
- Dyskinesias, Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQW051Drug
Patients will receive AQW051 in a high dose once daily orally for 28 days.
AQW051Drug
Patients will receive AQW051 in a low dose once daily orally for 28 days.
PlaceboDrug
Patients will receive placebo once daily orally for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| AQW051 High Dose | Experimental | AQW051 high dose daily given orally for 28 days. Receives: Drug: AQW051 |
| AQW051 Low Dose | Experimental | AQW051 low dose daily given orally for 28 days. Receives: Drug: AQW051 |
| Placebo | Placebo comparator | Placebo daily given orally for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score
Dyskinesia with a maximal score of 24.
Measured: Baseline, Day 28
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score
Anti-parkinsonian effect in PD patients.
Measured: 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
Measured: Up to Day 42
Secondary outcomes (5)
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.
Measured: Up to Day 42
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.
Measured: Up to Day 42
Track-PD
Objective measures of motor function.
Measured: Up to Day 42
CogState
Cognitive function, including simple and choice reaction time, episodic visual and verbal memory, working memory, planning and strategy, and executive function.
Measured: Up to Day 28
Area under the curve (AUC[0-24hr]) of AQW051
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study start15 Sep 2011
- Primary completion21 Feb 2013
- Study completion21 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyskinesiasStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474421
- Sponsor's protocol ID
- CAQW051A2209
- Other IDs
- 2011-001092-39
- Status last verified
- May 2017
- First submitted
- 5 Oct 2011
- Last updated
- 24 Dec 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 26990766
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01474421
- Acronym / sponsor ID
- CAQW051A2209
- Conditions
- Dyskinesias, Drug-induced
- Keywords
- Parkinson's disease, Dyskinesia, Movement disorders, L-dopa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2011 (actual)
- Primary completion
- 21 Feb 2013 (actual)
- Study completion
- 21 Feb 2013 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AQW051 High Dose | Experimental | Drug: AQW051AQW051 high dose daily given orally for 28 days. |
| AQW051 Low Dose | Experimental | Drug: AQW051AQW051 low dose daily given orally for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily given orally for 28 days. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQW051Patients will receive AQW051 in a high dose once daily orally for 28 days. | Drug | AQW051 High Dose |
| AQW051Patients will receive AQW051 in a low dose once daily orally for 28 days. | Drug | AQW051 Low Dose |
| PlaceboPatients will receive placebo once daily orally for 28 days. | Drug | Placebo |
Primary outcome
Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score
Time frame: Baseline, Day 28
Dyskinesia with a maximal score of 24.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score
Time frame: Baseline, Day 28
Anti-parkinsonian effect in PD patients.
Safety and tolerability
Time frame: Up to Day 42
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
5 secondary outcomes
Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)
Time frame: Up to Day 42
Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33
Time frame: Up to Day 42
Track-PD
Time frame: Up to Day 42
CogState
Time frame: Up to Day 28
Area under the curve (AUC[0-24hr]) of AQW051
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Results publication: PubMed 26990766Trenkwalder 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 for CAQW051A2209 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AQW051 in people with Dyskinesias and Drug-induced, run by Novartis Pharmaceuticals at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, Germany, United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score (time frame: Baseline, Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.