NCT01767129

Brief Summary

To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

October 16, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2015

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

April 29, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

January 9, 2013

Results QC Date

December 22, 2021

Last Update Submit

April 4, 2022

Conditions

DyskinesiaParkinson's Disease

Keywords

levodopadyskinesiaparkinson's diseaseAVP-923dextromethorphanquinidine

Outcome Measures

Primary Outcomes (1)

  • Least Squares Mean Dyskinesia Severity Area Under the Curve (AUC) Score As Assessed By Modified Movement Disorder Society-Unified Dyskinesia Rating Scale (MDS-UDysRS) Part 3

    The MDS-UDysRS was developed to evaluate involuntary movements often associated with treated Parkinson's disease (PD). Levodopa-Induced Dyskinesia severity was assessed via video analysis by unbiased blinded central raters, and was calculated using the Intensity Scale from Part 3 of the MDS-UDysRS. The Intensity Scale was made up of seven body parts: face, neck, right arm/shoulder, left arm/shoulder, trunk, right leg/hip, and left leg/hip. Each body part was scored on a variety of disability items (communication, drinking, and ambulation \[walking\]) on a scale of 0 (normal) to 4 (incapacitating dyskinesia) with a maximum total score of 28. For each body part, the highest disability score was summed to calculate the intensity score. A score of '0' was assigned to questions associated with the dressing task which were not performed due to the placement of the treatment infusion (IV) line. A higher score indicated more severe symptoms.

    Over the 2-hour levodopa infusion period on the last day of each treatment period (Day 14 and Day 42)

Secondary Outcomes (10)

  • Least Squares Mean Disability Area Under the Curve (AUC) Score As Assessed By Modified Movement Disorder Society-Unified Dyskinesia Rating Scale (MDS-UDysRS) Part 4

    Over the 2-hour levodopa infusion period on the last day of each treatment period (Day 14 and Day 42)

  • Least Squares Mean Motor Movement Area Under the Curve Score As Assessed by Modified Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III

    Over the 2-hour levodopa infusion period on the last day of each treatment period (Day 14 and Day 42)

  • Least Squares Mean Timed Finger Tapping Area Under the Curve (AUC) Score

    Over the 2-hour levodopa infusion period on the last day of each treatment period (Day 14 and Day 42)

  • Change From Baseline in MDS-UPDRS Scores for Part I, II, and IV

    Baseline (Day 1); Post-Baseline (Day 14 or 42)

  • Change From Baseline in MDS-UDysRS Scores for Part 1 and 2

    Baseline (Day 1); Post-Baseline (Day 14 or 42)

  • +5 more secondary outcomes

Study Arms (2)

AVP-923-45

EXPERIMENTAL

AVP-923-45 twice daily for 14 days

Drug: AVP-923-45

Placebo

PLACEBO COMPARATOR

Placebo twice a day for 14 days

Drug: Placebo

Interventions

AVP-923-45DRUG

One capsule twice daily for 14 days

Also known as: dextromethorphan/quinidine
AVP-923-45
PlaceboDRUG

One capsule twice daily for 14 days

Placebo

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females 30 to 80 years of age, inclusive.
  • Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society Brain Bank criteria.
  • Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.
  • Dyskinesia of at least moderate severity as per MDS-UPDRS
  • Amantadine and Monoamine Oxidase (MAO) inhibitors must be discontinued at least three weeks prior to randomization.
  • Subjects currently receiving anti-parkinsonian medications, including all Levodopa preparations are eligible provided they have been on a stable dose of these medications for at least 1 month prior to randomization.
  • Concomitant use of antidepressants such as selective serotonin reuptake inhibitors are allowed, provided the dose has been stable for at least 1 month prior to randomization.

You may not qualify if:

  • Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain Stimulation must not have been performed within one year of screening)
  • Hoehn and Yahr score of 5 when "off".
  • Subject with Cognitive impairment and/or history of psychiatric manifestations or active hallucinations.
  • Subjects with any history of complete heart block, QTc prolongation, or torsades de pointes.
  • Subjects with any family history of congenital QT interval prolongation syndrome.
  • Subjects with history of postural syncope, or any history of unexplained syncope within the last 12 months.
  • Subjects with a history of substance and/or alcohol abuse within the past 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

  • Fox SH, Metman LV, Nutt JG, Brodsky M, Factor SA, Lang AE, Pope LE, Knowles N, Siffert J. Trial of dextromethorphan/quinidine to treat levodopa-induced dyskinesia in Parkinson's disease. Mov Disord. 2017 Jun;32(6):893-903. doi: 10.1002/mds.26976. Epub 2017 Mar 30.

    PMID: 28370447RESULT

Related Links

MeSH Terms

Conditions

DyskinesiasParkinson Disease

Interventions

dextromethorphan - quinidine combination

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Avanir Medical Information
Organization
Avanir Pharmaceuticals
medinfo@avanir.com
855-572-2722

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 14, 2013

Study Start

October 16, 2013

Primary Completion

February 5, 2015

Study Completion

February 5, 2015

Last Updated

April 29, 2022

Results First Posted

April 29, 2022

Record last verified: 2022-04

Locations

US(2)CA(1)