Parkinson's DiseasePhase 2NCT00605553
Study to Evaluate SYN115 in Parkinson's Disease
A Phase 2 study testing Tozadenant in people with Parkinson's Disease, run by Biotie Therapies Inc. at 1 site in United States.
Trial summary
This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Tozadenant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease
- Hoen and Yahr stage 1-3
- On stable dose of anti-parkinsons treatment for 30 days prior to screening
- Age 40 to 75 years
- Sign an IRB approved informed consent
- Men and women agree to use adequate birth control
- ECG measurements are within normal limits
- Able to understand study requirements
Who cannot join
- Secondary Parkinson's (drug induced or post stroke)
- Received treatment with other investigational drug 30 days prior to study entry
- Using disallowed medications
- Significant neurological illness other than Parkinson's
- IQ less than 70 on IQ test
- MMSE score < or = 23
Show all 16Show fewer
- History of psychosis or on anti-psychotic medication
- Current serious medical illness
- History of substance abuse
- History of head injury with loss of consciousness
- History of brain surgery
- Contraindications to MRI like claustrophobia, metal implants or other implantable devices
- Abnormal liver function tests and/or hepatitis or cholangitis
- Gilberts disease
- Pregnant or nursing
- Known hypersensitivity to SYN115
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University St. Louis
St Louis, Missouri, 63110
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease
This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive design will be used to determine if SYN115 elicits effects relevant to PD in the fewest number of patients by performing interim analyses in successive cohorts of patients receiving 60 or 20 mg.
- Conditions
- Parkinson's Disease
- Being tested
- Placebo, Tozadenant
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo oral capsules
Placebo for 7 days
TozadenantDrug
Also called A2a antagonist, SYN115
20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID Receives: Drug: Tozadenant |
| 2 | Placebo comparator | Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is an exploratory study to evaluate effects of SYN115 in patients with PD, as determined by clinical and fMRI evaluation. The results of this initial study will help determine the range to be used in subsequent studies.
Measured: Before treatment and at the end of each treatment period
Secondary outcomes (3)
Pittsburgh side effect scale
Measured: Before, after the first dose and end of each treatment period
VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety
Measured: Before, after the first dose and end of each treatment period
Measurement of motor symptoms of Parkinson's disease and tapping speed
Measured: Before, after the first dose and end of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotie Therapies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Bandak, MB BS MRCP, Study chair, Synosia TherapeuticsAnn Neale, RN, Study director, Synosia TherapeuticsUwe Meya, MD, Study chair, Synosia TherapeuticsKevin J Black, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605553
- Sponsor's protocol ID
- SYN115-CL01
- Status last verified
- Aug 2017
- First submitted
- 15 Jan 2008
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Black KJ, Campbell MC, Dickerson W, Creech ML, Koller JM, Chung SC, Bandak SI: A randomized, double-blind, placebo-controlled cross-over trial of the adenosine 2a antagonist SYN115 in Parkinson disease. Neurology 74(9): A317, 2010.
Black KJ, Koller JM, Campbell MC, Gusnard DA, Bandak SI. Quantification of indirect pathway inhibition by the adenosine A2a antagonist SYN115 in Parkinson disease. J Neurosci. 2010 Dec 1;30(48):16284-92. doi: 10.1523/JNEUROSCI.2590-10.2010.
PubMed 21123574
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00605553
- Acronym / sponsor ID
- SYN115-CL01
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biotie Therapies Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered.
Detailed description
This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive design will be used to determine if SYN115 elicits effects relevant to PD in the fewest number of patients by performing interim analyses in successive cohorts of patients receiving 60 or 20 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TozadenantActive medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID |
| 2 | Placebo comparator | Drug: PlaceboCrossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Parkinson's disease
- Hoen and Yahr stage 1-3
- On stable dose of anti-parkinsons treatment for 30 days prior to screening
- Age 40 to 75 years
- Sign an IRB approved informed consent
Key exclusion criteria (16 listed)
- Secondary Parkinson's (drug induced or post stroke)
- Received treatment with other investigational drug 30 days prior to study entry
- Using disallowed medications
- Significant neurological illness other than Parkinson's
- IQ less than 70 on IQ test
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 |
|---|---|---|
| PlaceboPlacebo oral capsules Placebo for 7 days | Drug | 2 |
| TozadenantAlso: A2a antagonist, SYN11520 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID | Drug | 1 |
Primary outcome
This is an exploratory study to evaluate effects of SYN115 in patients with PD, as determined by clinical and fMRI evaluation. The results of this initial study will help determine the range to be used in subsequent studies.
Time frame: Before treatment and at the end of each treatment period
3 secondary outcomes
Pittsburgh side effect scale
Time frame: Before, after the first dose and end of each treatment period
VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety
Time frame: Before, after the first dose and end of each treatment period
Measurement of motor symptoms of Parkinson's disease and tapping speed
Time frame: Before, after the first dose and end of each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Results publicationBlack KJ, Campbell MC, Dickerson W, Creech ML, Koller JM, Chung SC, Bandak SI: A randomized, double-blind, placebo-controlled cross-over trial of the adenosine 2a antagonist SYN115 in Parkinson disease. Neurology 74(9): A317, 2010.
- Results publication: PubMed 21123574Black KJ, Koller JM, Campbell MC, Gusnard DA, Bandak SI. Quantification of indirect pathway inhibition by the adenosine A2a antagonist SYN115 in Parkinson disease. J Neurosci. 2010 Dec 1;30(48):16284-92. doi: 10.1523/JNEUROSCI.2590-10.2010.
Related trials for Parkinson's Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
Parkinsons Disease (PD)
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
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.
Steve Bandak, MB BS MRCP study chair
Synosia Therapeutics
Ann Neale, RN study director
Synosia Therapeutics
Uwe Meya, MD study chair
Synosia Therapeutics
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 Tozadenant in people with Parkinson's Disease, run by Biotie Therapies Inc. 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 8 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
This is an exploratory study to evaluate effects of SYN115 in patients with PD, as determined by clinical and fMRI evaluation. The results of this initial study will help determine the range to be used in subsequent studies. (time frame: Before treatment and at the end of each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00605553, which also lists 2 linked publications.
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 8 Aug 2017.