OPTI-ON: Opicapone Treatment Initiation Open-Label Study

• Sponsor: Neurocrine Biosciences (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04787965
• Collaborator: (none)
• Enrollment: 243
• Locations: 6
• Anticipated Duration (Months): 16
• Patients Per Site: 40.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing "off" episodes with motor fluctuations

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: Opicapone

Study Design

• Study Type: Observational
• Actual Enrollment: 243 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Opicapone Treatment Initiation Open-Label Study
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
ONGENTYS Opicapone 50 mg capsule once daily for 6 months	Drug: Opicapone; Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period; Other Names: ONGENTYS

Outcome Measures

Primary Outcome Measures

1. ONGENTYS treatment patterns [6 months]

   Reason for initiating treatment and discontinuation

Secondary Outcome Measures

1. PD Status [6 months]

   PD Status Questionnaire

2. CGI-C [6 months]

   Clinical Global Impression of Change Scale

3. MDS-UPDRS Parts I, II, and IV [6 months]

   Movement Disorder Society-Unified Parkinson's Disease Rating Scale

4. PDQ-8 [6 months]

   Parkinson's Disease Questionnaire-8

5. PGI-C [6 months]

   Patient Global Impression of Change Scale

6. NoMoFa [6 months]

   Non-Motor Fluctuation Assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be able to complete electronic patient-reported outcome instruments

• Parkinson's disease patients experiencing "off" episodes

• Patient receiving concomitant levodopa/carbidopa, and as deemed appropriate by the physician, newly initiating ONGENTYS as adjunctive treatment

Exclusion Criteria:

• Patient is not cognitively able to complete the study requirements

• Patient is not able to complete the study duration of 6 months

• History of moderate or severe hepatic impairment

• Patient has end-stage renal disease

• Concomitant use of non-selective monoamine oxidase (MAO) inhibitor or catechol-O-methyltransferase (COMT) inhibitors (patients entering study may switch from other COMT inhibitors to ONGENTYS)

• History of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms

• Currently enrolled in an interventional clinical trial

• Currently or previously received ONGENTYS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurocrine clinical site	Los Gatos	California	United States	95032
2	Neurocrine clinical site	Memphis	Tennessee	United States	38157
3	Neurocrine clinical site	Christiansburg	Virginia	United States	24073
4	Neurocrine clinical site	Norfolk	Virginia	United States	68134
5	Neurocrine clinical site	Auburn	Washington	United States	98002
6	Neurocrine clinical site	Crab Orchard	West Virginia	United States	25827

Sponsors and Collaborators

• Neurocrine Biosciences

Investigators

• Study Director: Olga Klepitskaya, MD, FAAN, Neurocrine Biosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P; Bi-Park 1 investigators. Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2016 Feb;15(2):154-165. doi: 10.1016/S1474-4422(15)00336-1. Epub 2015 Dec 23.
• Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P; BIPARK-2 Study Investigators. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):197-206. doi: 10.1001/jamaneurol.2016.4703.

• Responsible Party: Neurocrine Biosciences
• ClinicalTrials.gov Identifier: NCT04787965
• Other Study ID Numbers: NBI-OPC-PD4006
• First Posted: Mar 9, 2021
• Last Update Posted: Apr 11, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Neurocrine Biosciences: Parkinson's disease (PD); Levodopa; Carbidopa; Motor Fluctuations; Non-Motor Fluctuations; Adjunctive treatment; COMT inhibitor
• Additional relevant MeSH terms: Parkinson Disease; Opicapone

Study Results

No Results Posted as of Apr 11, 2022