Phase 2
N=14
Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients
Dyskinesia · Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01767129 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: 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 — 966.0; 1049.4 (Score on a scale)*hour — p=0.1907
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AVP-923-45 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Avanir Pharmaceuticals
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
966.0; 1049.4 | 0.1907 |
| SECONDARY 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 |
409.4; 428.3 | 0.3880 |
| SECONDARY 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 |
6568.9; 6397.0 | 0.7574 |
| SECONDARY Least Squares Mean Timed Finger Tapping Area Under the Curve (AUC) Score |
820.9; 772.1 | 0.4203 |
| SECONDARY Change From Baseline in MDS-UPDRS Scores for Part I, II, and IV |
-1.2; -0.1; -0.0; -0.2; -2.9; -0.5 | 0.1067 |
| SECONDARY Change From Baseline in MDS-UDysRS Scores for Part 1 and 2 |
-3.9; 0.00; -0.7; 0.6 | 0.0625 |
| SECONDARY Change From Baseline in PD Motor Diary Ratings Of Duration Of "On-time Without Bothersome Dyskinesia" |
0.5; 0.5 | 0.9764 |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Domain Scores at the End of Each Treatment Period |
0.2; 2.0; -4.6; 3.9; -4.5; 2.9 | 0.6359 |
| SECONDARY Change From Baseline in PDQ-39 Single Index (PDQ-39-SI) Scores at the End of Each Treatment Period |
-4.2; 2.2 | 0.0233 sig |
| SECONDARY Change From Screening in the Montreal Cognitive Assessment (MoCA) Calculated Score at the End of Each Treatment Period |
0.1; 0.6 | 0.1930 |
| SECONDARY Change From Baseline in the Dyskinesia and Other PD Symptoms Score As Assessed by Patient Global Impression of Change (PGIC) |
2.7; 3.7; 4.2; 4.1 | 0.0511 |
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01767129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.