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COMPLETED Phase 2

Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia

NCT01092065 · View on ClinicalTrials.gov ↗

Study Summary

This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG AFQ056 with L-dopa

Study Locations (4)

California

  • The Parkinsons Institute — Sunnyvale

Colorado

  • Colorado Neurological Institute — Englewood

Indiana

  • Indiana University School of Medicine — Indianapolis

Kansas

  • University of Kansas Medical Center - Parkinson's Disease and Movement Disorders Center — Kansas City

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2010-03
Est. Completion 2011-07
Phase Phase 2

Sponsor

Novartis

60 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01092065

The ClinicalTrials.gov registry entry for NCT01092065 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01092065 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Colorado, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01092065 about?

NCT01092065 is a clinical study titled "Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia". This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.

What is the current status of trial NCT01092065?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2010-03. Estimated completion is 2011-07.

What conditions does trial NCT01092065 study?

This clinical trial studies the following conditions: Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01092065?

The interventions under investigation include: Placebo (DRUG), AFQ056 with L-dopa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01092065?

This trial is sponsored by Novartis, which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01092065 being conducted?

This trial has 4 study locations across California, Colorado, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial