Parkinson DiseasePhase 2NCT01264861

A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging

A Phase 2 study testing Safinamide in people with Parkinson Disease, run by Newron Pharmaceuticals SPA at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Parkinson Disease
What is being tested?: Safinamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: Mar 2011to 24 Jan 2012
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, between 40-80 years of age.
Subject must have a diagnosis of idiopathic Parkinson's disease, and a Hoehn and Yahr stage of I-III.
Subjects must be concomitantly treated with a stable dose of a single dopamine agonist prior to the screening visit.
Subjects must be able to understand and willing to sign an approved Informed Consent form.
Female subjects must be neither pregnant or breast-feeding.

Who cannot join

Subjects with any form of Parkinsonism other than idiopathic Parkinson's disease.
Subjects currently experiencing motor fluctuations (end of dose wearing off), dyskinesias, or significant postural hypotension.
Subjects treated with l-dopa, anticholinergics, amantadine, MAO inhibitors, COMT inhibitors, tricyclic antidepressants, and / or SSRI and SNRI antidepressants.
Subjects with a history of psychosis, either previously or currently, or a score ≥ 3 on item 2 or 3 of the UPDRS Part I.
Subjects with evidence of dementia or cognitive dysfunction.
Subjects with current diagnosis of substance abuse or history of alcohol or drug abuse in the past three months.

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Subjects with current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease, and Type I diabetes.
Subjects with a concomitant disease likely to alter absorption, metabolism or elimination of the study drug.
Female subjects must be neither pregnant nor lactating.
Subjects with hypersensitivity or contraindications to MAO-B inhibitors.
Subjects with a neoplastic disorder, which is either currently active or has been in remission for less than one year.
Subjects with second- or third-degree atrio-ventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within three months of the screening visit, or significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
Subjects with a history or a current diagnosis of human immunodeficiency virus infection, or tests positive for Hepatitis B surface antigen, tests positive for Hepatitis B core antibody, but negative for Hepatitis B surface antibody, or tests positive for Hepatitis C antibodies.
Subjects who have participated in a previous clinical trial with safinamide, have participated in a previous clinical trial within 30 days of entry into the study, or have received treatment with any investigational compound within thirty days or five half-lives, whichever is longer, prior to screening.
Subjects with any abnormality that the investigator deems to be clinically relevant.
Legal incapacity or limited legal capacity
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Treatment with a drug that has hepatotoxic potential within 4 weeks, or received radiation therapy or a drug with cytotoxic potential within one year prior to the screening visit.
Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity, retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation, or diabetic retinopathy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Molecular Neuroimaging, LLC
New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: Open-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease Patients

This is a study of safinamide, an investigational drug for Parkinson disease (PD). Safinamide is being developed as add-on therapy for the treatment of Parkinson disease. It is theorized that safinamide acts by increasing the available dopamine in those areas of the brain where dopamine is decreased as a result of Parkinson;s Disease. . Dopamine in the brain is involved in controlling body movements. Safinamide has been extensively studied in animals, and has been shown to increase the level of dopamine in these animals. Safinamide has also been tested in patients with Parkinson disease. The goal of this research trial is to see if safinamide is safe and well tolerated and to better understand how it affects the dopamine system in the brain in individuals with Parkinson disease. Data from this trial may provide essential information about the effectiveness and safety of these doses of safinamide in patients with early Parkinson disease, who are already receiving a stable dose of their normal Parkinson disease treatment.

Conditions: Parkinson Disease
Being tested: Safinamide
Keywords: Evaluate dopamine and serotonin activity in the brain at 3 doses of Safinamide
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SafinamideDrug
Safinamide 100 mg/day = two 50 mg tablets administered orally, once a day, in the morning, with or without food.
Safinamide 200 mg/day = four 50 mg tablets administered orally, once a day, in the morning, with or without food; this will be preceded by a three day titration of 150 mg = three 50 mg tablets administered orally, once a day, in the morning, with or without food.
Safinamide 300 mg/day = six 50 mg tablets administered orally, once a day, in the morning, with or without food; this will be preceded by a three day titration of 250 mg = five 50 mg tablets administered orally, once a day, in the morning, with or without food.

Study groups in NCT01264861
Study group	Role	What they receive
Arm 1:	Experimental	Arm 1: Eligible subjects will receive escalating doses of safinamide for the 6-week duration of treatment. Each dose level will be last 10-14 days. Doses 200mg and 300mg will have a 3 day intermediate step up dose, 150mg and 250mg dose. Receives: Drug: Safinamide

What is being measured

The primary outcome is the main question the study is designed to answer.

The percent change from baseline to steady state (end of dosing period for 100 mg daily safinamide doses) on quantitative determinations of occupancy of the dopamine transporter in striatum as determined by [123|] ß-CIT SPECT scanning.
Measured: Every two weeks for six weeks
The percent change from baseline to steady state (end of dosing period for 200 mg daily safinamide doses) on quantitative determinations of occupancy of the dopamine transporter in striatum as determined by [123|] ß-CIT SPECT scanning.
Measured: Every two weeks for six weeks
The percent change from baseline to steady state (end of dosing period for 300 mg daily safinamide doses) on quantitative determinations of occupancy of the dopamine transporter in striatum as determined by [123|] ß-CIT SPECT scanning.
Measured: Every two weeks for six weeks

Secondary outcomes (3)

The percent change from baseline to steady state (end of dosing period for 100 mg daily safinamide doses) on quantitative determinations of occupancy of the serotonin transporter in brainstem as determined by [123|] ß-CIT SPECT scanning.
Measured: Every two weeks for six weeks
The percent change from baseline to steady state (end of dosing period for 200 mg daily safinamide doses) on quantitative determinations of occupancy of the serotonin transporter in brainstem as determined by [123|] ß-CIT SPECT scanning.
Measured: Every two weeks for six weeks
The percent change from baseline to steady state (end of dosing period for 300 mg daily safinamide doses) on quantitative determinations of occupancy of the serotonin transporter in brainstem as determined by [123|] ß-CIT SPECT scanning.
Measured: Every two weeks for six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201124 Jan 2012

First posted22 Dec 2010 (estimated)
Study startMar 2011
Primary completionJan 2012
Study completion24 Jan 2012

Why it stopped: The Dopamine transporter brain imaging trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01264861
Sponsor's protocol ID: 28849
Status last verified: Sep 2017
First submitted: 20 Dec 2010
Last updated: 18 Sep 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease Patients
ClinicalTrials.gov ID: NCT01264861
Acronym / sponsor ID: 28849
Conditions: Parkinson Disease
Keywords: Evaluate dopamine and serotonin activity in the brain at 3 doses of Safinamide
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The Dopamine transporter brain imaging trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals
Enrolment: 5 participants (actual)
Lead sponsor: Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
Study start: Mar 2011 (actual)
Primary completion: Jan 2012 (actual)
Study completion: 24 Jan 2012 (actual)
First posted: 22 Dec 2010 (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.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1:	Experimental	Drug: SafinamideArm 1: Eligible subjects will receive escalating doses of safinamide for the 6-week duration of treatment. Each dose level will be last 10-14 days. Doses 200mg and 300mg will have a 3 day intermediate step up dose, 150mg and 250mg dose.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female, between 40-80 years of age.
Subject must have a diagnosis of idiopathic Parkinson's disease, and a Hoehn and Yahr stage of I-III.
Subjects must be concomitantly treated with a stable dose of a single dopamine agonist prior to the screening visit.
Subjects must be able to understand and willing to sign an approved Informed Consent form.
Female subjects must be neither pregnant or breast-feeding.

Key exclusion criteria (19 listed)

Subjects with any form of Parkinsonism other than idiopathic Parkinson's disease.
Subjects currently experiencing motor fluctuations (end of dose wearing off), dyskinesias, or significant postural hypotension.
Subjects treated with l-dopa, anticholinergics, amantadine, MAO inhibitors, COMT inhibitors, tricyclic antidepressants, and / or SSRI and SNRI antidepressants.
Subjects with a history of psychosis, either previously or currently, or a score ≥ 3 on item 2 or 3 of the UPDRS Part I.
Subjects with evidence of dementia or cognitive dysfunction.

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
SafinamideSafinamide 100 mg/day = two 50 mg tablets administered orally, once a day, in the morning, with or without food. Safinamide 200 mg/day = four 50 mg tablets administered orally, once a day, in the morning, with or without food; this will be preceded by a three day titration of 150 mg = three 50 mg tablets administered orally, once a day, in the morning, with or without food. Safinamide 300 mg/day = six 50 mg tablets administered orally, once a day, in the morning, with or without food; this will be preceded by a three day titration of 250 mg = five 50 mg tablets administered orally, once a day, in the morning, with or without food.	Drug	Arm 1:

Primary outcome

The percent change from baseline to steady state (end of dosing period for 100 mg daily safinamide doses) on quantitative determinations of occupancy of the dopamine transporter in striatum as determined by [123|] ß-CIT SPECT scanning.
Time frame: Every two weeks for six weeks
The percent change from baseline to steady state (end of dosing period for 200 mg daily safinamide doses) on quantitative determinations of occupancy of the dopamine transporter in striatum as determined by [123|] ß-CIT SPECT scanning.
Time frame: Every two weeks for six weeks
The percent change from baseline to steady state (end of dosing period for 300 mg daily safinamide doses) on quantitative determinations of occupancy of the dopamine transporter in striatum as determined by [123|] ß-CIT SPECT scanning.
Time frame: Every two weeks for six weeks

3 secondary outcomes

The percent change from baseline to steady state (end of dosing period for 100 mg daily safinamide doses) on quantitative determinations of occupancy of the serotonin transporter in brainstem as determined by [123|] ß-CIT SPECT scanning.
Time frame: Every two weeks for six weeks
The percent change from baseline to steady state (end of dosing period for 200 mg daily safinamide doses) on quantitative determinations of occupancy of the serotonin transporter in brainstem as determined by [123|] ß-CIT SPECT scanning.
Time frame: Every two weeks for six weeks
The percent change from baseline to steady state (end of dosing period for 300 mg daily safinamide doses) on quantitative determinations of occupancy of the serotonin transporter in brainstem as determined by [123|] ß-CIT SPECT scanning.
Time frame: Every two weeks for six weeks

Results and safety

The study was stopped early (reason given: The Dopamine transporter brain imaging trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.

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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.

Kenneth Marek, MD study director

Molecular Neuroimaging / Institute for Neurodegenerative Disorders

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 Safinamide in people with Parkinson Disease, run by Newron Pharmaceuticals SPA 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 5 inclusion and 19 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 18 Sep 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. 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?

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?

The percent change from baseline to steady state (end of dosing period for 100 mg daily safinamide doses) on quantitative determinations of occupancy of the dopamine transporter in striatum as determined by [123|] ß-CIT SPECT scanning. (time frame: Every two weeks for six weeks). The study lists 3 primary outcomes in all. 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 NCT01264861.

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 18 Sep 2017.