Parkinson's DiseasePhase 2NCT02162979
Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease
A Phase 2 study testing sildenafil in people with Parkinson's Disease, run by Loma Linda University at 1 site in United States.
Trial summary
This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.
- Presence of drug-induced dyskinesias
- Age>40 years.
- Willingness and ability to comply with the study requirements and give informed consent.
Who cannot join
- Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
- History of stereotaxic brain surgery.
- Clinical history of dementia.
- Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
- History of major hematological, renal, or hepatic abnormalities.
- 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.
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- History of stroke within the last 6 months.
- Abnormal EKG consistent with cardiac ischemia.
- Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
- Malignant hypertension or SBP . 180 or <90, or DBP .110 or <50.
- History of priapism.
- Known history of retinitis pigmentosa.
- Positive pregnancy test.
- History of bleeding disorder.
- Patients with active peptic ulcer disease associated with bleeding.
- Unwillingness to use adequate contraceptive methods if of childbearing potential.
- Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
- Use of Viagra or any experimental drugs within 30 days of screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease
This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.
Read the detailed description
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease.
- Age > 40 years.
- willingness and ability to comply with the study requirements and give informed consent.
- Conditions
- Parkinson's Disease
- Being tested
- sildenafil, Placebo
- Keywords
- Parkinson's disease, PD, dyskinesia, treatment, motor complications
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
Also called Viagra
sildenafil 50mg BID for 2 weeks
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Viagra | Experimental | subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. Receives: Drug: sildenafil |
| Placebo comparator | Placebo comparator | subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Duration of Dyskinesia.
Measured: 2 weeks
Secondary outcomes (2)
Percent Change in "on" Time
"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.
Measured: 4 weeks
Change in Dose of Anti-parkinsonian Medications
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startFeb 2002
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Not enough subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M. Swope, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162979
- Sponsor's protocol ID
- 52031
- Status last verified
- Mar 2018
- First submitted
- 26 Dec 2007
- Last updated
- 30 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02162979
- Acronym / sponsor ID
- 52031
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, PD, dyskinesia, treatment, motor complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough subjects.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Posted 22 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.
Detailed description
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease.
- Age > 40 years.
- willingness and ability to comply with the study requirements and give informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viagra | Experimental | Drug: sildenafilsubjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. |
| Placebo comparator | Placebo comparator | Drug: Placebosubjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.
- Presence of drug-induced dyskinesias
- Age>40 years.
- Willingness and ability to comply with the study requirements and give informed consent.
Key exclusion criteria (18 listed)
- Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
- History of stereotaxic brain surgery.
- Clinical history of dementia.
- Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
- History of major hematological, renal, or hepatic abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafilAlso: Viagrasildenafil 50mg BID for 2 weeks | Drug | Viagra |
| Placebo | Drug | Placebo comparator |
Primary outcome
Change in Duration of Dyskinesia.
Time frame: 2 weeks
2 secondary outcomes
Percent Change in "on" Time
Time frame: 4 weeks
Change in Dose of Anti-parkinsonian Medications
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Swope, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sildenafil in people with Parkinson's Disease, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Duration of Dyskinesia. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.