Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients (LID in PD)
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ClinicalTrials.gov Identifier: NCT01767129 |
Recruitment Status :
Completed
First Posted : January 14, 2013
Last Update Posted : January 11, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyskinesia Parkinson's Disease | Drug: AVP-923-45 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients. |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: AVP-923-45
AVP-923-45 twice daily for 14 days
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Drug: AVP-923-45
One capsule twice daily for 14 days
Other Name: dextromethorphan/quinidine |
Placebo Comparator: Placebo
Placebo twice a day for 14 days
|
Drug: Placebo
One capsule twice daily for 14 days |
- Unified Dyskinesia Rating Scale (UDysRS), part 3 [ Time Frame: 2 weeks ]
- UDysRS, part 4 [ Time Frame: 2 Weeks ]
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III-motor score [ Time Frame: 2 Weeks ]
- Bradykinesia [ Time Frame: 2 Weeks ]
- MDS-UPDRS part I, II, and IV [ Time Frame: 2 Weeks ]
- UDysRS part 1 and 2 [ Time Frame: 2 Weeks ]
- PD Motor Diary [ Time Frame: 2 Weeks ]

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767129
United States, Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Oregon | |
Portland, Oregon, United States, 97239 | |
Canada, Ontario | |
Toronto, Ontario, Canada, M5T 2S8 |
Responsible Party: | Avanir Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01767129 |
Other Study ID Numbers: |
12-AVR-133 |
First Posted: | January 14, 2013 Key Record Dates |
Last Update Posted: | January 11, 2018 |
Last Verified: | January 2018 |
levodopa dyskinesia parkinson's disease |
AVP-923 dextromethorphan quinidine |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Excitatory Amino Acid Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Muscarinic Antagonists Cholinergic Antagonists Dyskinesias Neurologic Manifestations |
Quinidine Dextromethorphan Antitussive Agents Respiratory System Agents Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agents Anti-Arrhythmia Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors |