## Protocol Section
### Identification Module
**NCT ID:** NCT02162979

**Brief Title:** Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease

**Official Title:** A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease

#### Organization Study ID Info
**ID:** 52031
#### Organization
**Class:** OTHER
**Full Name:** Loma Linda University
### Status Module
#### Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-03-30

**Type:** ACTUAL

**Last Update Submit Date:** 2018-03-05

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-07-22

**Type:** ESTIMATED

**Results First Submit Date:** 2014-06-20

**Results First Submit QC Date:** 2014-06-20

#### Start Date
**Date:** 2002-02

**Status Verified Date:** 2018-03

#### Study First Post Date
**Date:** 2014-06-13
**Type:** ESTIMATED
**Study First Submit Date:** 2007-12-26
**Study First Submit QC Date:** 2014-06-12
**Why Stopped:** Not enough subjects.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Loma Linda University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.

**Detailed Description:** Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease.
2. Age \> 40 years.
3. willingness and ability to comply with the study requirements and give informed consent.

### Conditions Module

**Conditions:**

- Parkinson's Disease

**Keywords:**

- Parkinson's disease

- PD

- dyskinesia

- treatment

- motor complications

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 2

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

**Intervention Names:**

- Drug: sildenafil

**Label:** Viagra

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo comparator

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Viagra

**Description:** sildenafil 50mg BID for 2 weeks

**Name:** sildenafil

**Other Names:**

- Viagra

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo comparator

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in Duration of Dyskinesia.

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Description:** "on" time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change.

**Measure:** Percent Change in "on" Time

**Time Frame:** 4 weeks

**Measure:** Change in Dose of Anti-parkinsonian Medications

**Time Frame:** 7 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.
2. Presence of drug-induced dyskinesias
3. Age\>40 years.
4. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

1. Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
2. History of stereotaxic brain surgery.
3. Clinical history of dementia.
4. Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
5. History of major hematological, renal, or hepatic abnormalities.
6. Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months.
7. History of stroke within the last 6 months.
8. Abnormal EKG consistent with cardiac ischemia.
9. Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
10. Malignant hypertension or SBP . 180 or \<90, or DBP .110 or \<50.
11. History of priapism.
12. Known history of retinitis pigmentosa.
13. Positive pregnancy test.
14. History of bleeding disorder.
15. Patients with active peptic ulcer disease associated with bleeding.
16. Unwillingness to use adequate contraceptive methods if of childbearing potential.
17. Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
18. Use of Viagra or any experimental drugs within 30 days of screening visit.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Loma Linda

**Country:** United States

**Facility:** Loma Linda University

**State:** California

**Zip:** 92354

#### Overall Officials

**Official 1:**

**Affiliation:** Loma Linda University

**Name:** David M. Swope, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22574

- Name: Dyskinesias

- Relevance: HIGH

- As Found: Dyskinesia

- 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

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

- ID: D000020820

- Term: Dyskinesias

### Intervention Browse Module - Ancestors

- ID: D000014665

- Term: Vasodilator Agents

- ID: D000058986

- Term: Phosphodiesterase 5 Inhibitors

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000064804

- Term: Urological Agents

### Intervention Browse Module - Browse Branches

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Urol

- Name: Urological Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M292

- Name: Sildenafil Citrate

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M21320

- Name: Citric Acid

- Relevance: LOW

- As Found: Unknown

- ID: M1837

- Name: Sodium Citrate

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29332

- Name: Phosphodiesterase 5 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T382

- Name: Citrate

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068677

- Term: Sildenafil Citrate

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Viagra

**Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks

**ID:** EG000

**Title:** Viagra

**Group ID:** EG001

**Title:** Placebo Comparator

**Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo

**ID:** EG001

**Title:** Placebo Comparator

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Units:** Participants

### Group

**ID:** BG000

**Title:** Viagra

**Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks

### Group

**ID:** BG001

**Title:** Placebo Comparator

**Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

**Category Title:** <=18 years

**Category Title:** Between 18 and 65 years

**Category Title:** >=65 years

**Class Title:** 

### Measure

### Measure

**Category Title:** Female

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Title:** Age, Categorical
### Measure 2
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Title:** Sex: Female, Male
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** thamilton@llu.edu
**Organization:** Loma Linda University
**Phone:** 909-558-4908
**Title:** Tonya Hamilton, reszearch Compliance Auditor
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
#### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Change in Duration of Dyskinesia.
**Type:** PRIMARY
##### Group
**Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks
**ID:** OG000
**Title:** Viagra
##### Group
**Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo
**ID:** OG001
**Title:** Placebo Comparator
#### Outcome Measure 2
**Description:** "on" time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change.
**Reporting Status:** POSTED
**Time Frame:** 4 weeks
**Title:** Percent Change in "on" Time
**Type:** SECONDARY
##### Group
**Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks
**ID:** OG000
**Title:** Viagra
##### Group
**Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo
**ID:** OG001
**Title:** Placebo Comparator
#### Outcome Measure 3
**Reporting Status:** POSTED
**Time Frame:** 7 weeks
**Title:** Change in Dose of Anti-parkinsonian Medications
**Type:** SECONDARY
##### Group
**Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks
**ID:** OG000
**Title:** Viagra
##### Group
**Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo
**ID:** OG001
**Title:** Placebo Comparator
### Participant Flow Module
#### Group
**Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks
**ID:** FG000
**Title:** Viagra
#### Group
**Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Placebo
**ID:** FG001
**Title:** Placebo Comparator
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** Documentation regarding the randomization of the two enrolled participants cannot be located. Therefore no meaningful data are available for entry in the data tables.
**Has Results:** True