## Protocol Section
### Identification Module
**NCT ID:** NCT06432309

**Acronym:** OPAILEC

**Brief Title:** Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease

**Official Title:** Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel

#### Organization Study ID Info
**ID:** 480/2022/Oss/AOUFe
#### Organization
**Class:** OTHER
**Full Name:** University Hospital of Ferrara
### Status Module
#### Completion Date
**Date:** 2024-04-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2022-10-01

**Type:** ACTUAL

**Status Verified Date:** 2022-07

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital of Ferrara

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC).

**Detailed Description:** 22 PD patients were randomized into LCIG monotherapy (n-OPC 11 patients) and LCIG+OPC (add-OPC 11 patients), further divided according to OPC adding time (E-OPC within one month and L-OPC after one month from LCIG implant).

Data on PD clinical aspects, Montreal Cognitive Assessment (MoCA), Unified Parkinson's Disease Rating Scale (UPDRS), Unified Dyskinesia Rating Scale (UDysRS), electroneurography (ENG), and pharmacological therapy (Levodopa Equivalent Dose-LEDD) were collected before LCIG implanted (T0) and in the following 12 (T1) months.

### Conditions Module

**Conditions:**

- Parkinson Disease

- Effect of Drug

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Prospective randomised blinded End-point study

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.

**Intervention Names:**

- Drug: Duodopa

**Label:** nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy

**Type:** OTHER

#### Arm Group 2

**Description:** Levodopa carbidopa intestinal gel infusion (Diurnal infusion from 7 a.m to 11 p.m) plus Opicapone 50 mg 1 tablet at nighttime (11 p.m)

**Intervention Names:**

- Drug: Opicapone 50 mg

- Drug: Duodopa

**Label:** add-OPC: Duodopa plus OPC therapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- add-OPC: Duodopa plus OPC therapy

**Description:** Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

**Name:** Opicapone 50 mg

**Other Names:**

- OPC

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- add-OPC: Duodopa plus OPC therapy

- nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy

**Description:** Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

**Name:** Duodopa

**Other Names:**

- Levodopa/carbidopa intestinal gel (LCIG)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.

**Measure:** Evaluation of motor fluctuations changes

**Time Frame:** 12 months

**Description:** Changes in UDysRS from the initial assessment to 12 months follow-up.

**Measure:** Evaluation of dyskinesia changes

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Changes of MDS-UPDRS I score from the initial assessment to 12 months follow-up.

**Measure:** Changes in non-motor aspects of patients' daily living experiences

**Time Frame:** 12 months

**Description:** Changes of of MDS-UPDRS II score from the initial assessment to 12 months follow-up.

**Measure:** Changes in motor aspects of patients' daily living experiences

**Time Frame:** 12 months

**Description:** Changes of MOCA score from the initial assessment to 12 months follow-up.

**Measure:** Changes in non-motor symptoms in Parkinson's disease-cognition

**Time Frame:** 12 months

**Description:** Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up.

**Measure:** Neurophysiological outcome

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. LCIG implantation not longer than 30 months before the study enrollment,
2. Presence of nocturnal akinesia (assessed by medical history and through item 2.9 of MDS-UPDRS part II (\> 2), or/and
3. Persistence of morning or afternoon akinesia (assessed by item 4.3 in MDS UPDRS -IV( \>2 ).

Exclusion Criteria:

1. Hoehn \& Yahr (H\&Y) \>4,
2. Cognitive decline (MOCA\< 17),
3. more than 30 months after LCIG positioning,
4. not compliant with treatment and follow-up visits.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ferrara

**Country:** Italy

**Facility:** University Hospital of Ferrara - Arcispedale Sant'Anna

**State:** Emilia Romagna

**Zip:** 44122

#### Overall Officials

**Official 1:**

**Affiliation:** Azienda Ospedaliero -Universitaria S. Anna Ferrara

**Name:** Mariachiara Sensi, MD-Phd

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Nyholm D, Jost WH. Levodopa-entacapone-carbidopa intestinal gel infusion in advanced Parkinson's disease: real-world experience and practical guidance. Ther Adv Neurol Disord. 2022 Jun 26;15:17562864221108018. doi: 10.1177/17562864221108018. eCollection 2022.

**PMID:** 35785401

**Citation:** Fabbri M, Ferreira JJ, Lees A, Stocchi F, Poewe W, Tolosa E, Rascol O. Opicapone for the treatment of Parkinson's disease: A review of a new licensed medicine. Mov Disord. 2018 Oct;33(10):1528-1539. doi: 10.1002/mds.27475. Epub 2018 Sep 27.

**PMID:** 30264443

**Citation:** Ikenaka K, Kajiyama Y, Aguirre C, Choong CJ, Taniguchi S, Doi J, Wang N, Ajiki T, Ogawa K, Kakuda K, Kimura Y, Mochizuki H. Decreased hepatic enzymes reflect the decreased vitamin B6 levels in Parkinson's disease patients. Pharmacol Res Perspect. 2024 Feb;12(1):e1174. doi: 10.1002/prp2.1174.

**PMID:** 38287715

**Citation:** Leta V, van Wamelen DJ, Sauerbier A, Jones S, Parry M, Rizos A, Chaudhuri KR. Opicapone and Levodopa-Carbidopa Intestinal Gel Infusion: The Way Forward Towards Cost Savings for Healthcare Systems? J Parkinsons Dis. 2020;10(4):1535-1539. doi: 10.3233/JPD-202022.

**PMID:** 32597817

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Intervention Browse Module - Ancestors

- ID: D000000978

- Term: Antiparkinson Agents

- ID: D000018726

- Term: Anti-Dyskinesia Agents

- ID: D000015259

- Term: Dopamine Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000065105

- Term: Aromatic Amino Acid Decarboxylase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000065098

- Term: Catechol O-Methyltransferase Inhibitors

- ID: D000000276

- Term: Adjuvants, Immunologic

- ID: D000007155

- Term: Immunologic Factors

- ID: D000018491

- Term: Dopamine Agonists

### Intervention Browse Module - Browse Branches

- Abbrev: AnDyAg

- Name: Anti-Dyskinesia Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CaAg

- Name: Cardiotonic Agents

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M10982

- Name: Levodopa

- Relevance: HIGH

- As Found: Lower limb

- ID: M5489

- Name: Carbidopa

- Relevance: HIGH

- As Found: Attending

- ID: M214057

- Name: Opicapone

- Relevance: HIGH

- As Found: Life Support

- ID: M250674

- Name: Carbidopa, levodopa drug combination

- Relevance: HIGH

- As Found: Few seconds

- ID: M4295

- Name: Antiparkinson Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M30461

- Name: Aromatic Amino Acid Decarboxylase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20595

- Name: Dopamine Agonists

- Relevance: LOW

- As Found: Unknown

- ID: T373

- Name: Catechol

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007980

- Term: Levodopa

- ID: D000002230

- Term: Carbidopa

- ID: C000549349

- Term: Opicapone

- ID: C000009265

- Term: Carbidopa, levodopa drug combination

### Misc Info Module

- Version Holder: 2024-05-31
