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Parkinson's DiseasePhase 3NCT01187966

Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease

A Phase 3 study testing Safinamide in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations who are currently receiving a stable dose of levodopa. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Safinamide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
669 participants
Where
No sites listed yet
Study dates
Jan 2007to Feb 2009
Phase
Phase 3
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are male or female, age 30-80 years, inclusive. If female, they must be either post-menopausal for at least 12 months, surgically sterilized or have undergone hysterectomy. Patients older than 80 years, who meet all other entry criteria, will be considered for enrollment, with approval of the Newron Medical Expert.
  • Patients must have a diagnosis of idiopathic Parkinson's disease of more than 5 years duration; the diagnosis should be based on medical history and neurological examination. Patients with a duration of Parkinson's disease of at least 3 years, who meet all other entry criteria, will be considered for enrollment, with approval of the CRO Medical Monitor.
  • Patients must have a Hoehn and Yahr stage of I-IV during an "off" phase.
  • Patients should be levodopa responsive and must have been receiving treatment with a stable dose of levodopa [4-10 doses per day of any levodopa preparation (including CR, IR or a combination of CR/IR), plus benserazide/carbidopa; with or without addition of a COMT inhibitor] and may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic at the screening visit. Patients will receive the study medication as add-on therapy starting at baseline.
  • Patients should have motor fluctuations, with >1.5 hours "off" time during the day.
  • Patients must be able to maintain an accurate and complete diary (18-hour), with the help of a caregiver, recording "on" time, "on" time with minor dyskinesia, "on" time with troublesome dyskinesia, "off" time, and time asleep.
  • Patients must be able to understand and willing to sign an approved Informed Consent form.

Who cannot join

  • The patient has any indication of forms of parkinsonism other than idiopathic Parkinson's disease.
  • If female, the patient is of childbearing potential, pregnant or lactating.
  • The patient is in a late stage of Parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.
  • The patient has a current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months.
  • The patient has a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well-controlled, asthma, chronic obstructive pulmonary disease (COPD), and Type I diabetes. Patients with a history of gastric ulcer who have not had an episode of acute gastritis in the last 6 months and are not currently experiencing gastric pain will be eligible for inclusion.
  • The patient has second- or third-degree atrio-ventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or a significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
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  • The patient has participated in a previous clinical trial with safinamide.
  • The patient has a concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug).
  • The patient has a history of psychosis (e.g. schizophrenia or psychotic depression), either previously or currently, or a score ≥ 3 on Item 2 (thought disorder) or 3 (depression) of the UPDRS Section I.
  • The patient has evidence of dementia or cognitive dysfunction, as indicated by a MMSE score < 22, or a score ≥ 3 on item 1 (mentation) of the UPDRS, Section I.
  • The patient is depressed, as indicated by a GRID-HAMD (17-item scale) score > 17.
  • The patient has a history of allergic response to anticonvulsants, levodopa, or other anti-parkinsonian agents.
  • The patient has a mental or physical condition (e.g., neurotic behaviour, crippling degenerative arthritis, or limb amputation), which would preclude performing efficacy or safety assessments.
  • The patient has hypersenstivity or contraindications to MAO B inhibitors.
  • The patient has a current history of severe dizziness or fainting on standing, due to postural hypotension.
  • The patient has a neoplastic disorder, which is either currently active or has been in remission for less than one year.
  • The patient has had stereotactic surgery as a treatment for his/her Parkinson's disease.
  • The patient has participated in a previous clinical trial within 30 days of entry into the study (screening visit) or has received treatment with any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to screening. The use of an investigational drug other than safinamide during the study is not permitted.
  • The patient is receiving treatment of his/her depression with a MAO inhibitor (e.g., selegiline), a tricyclic, or an SNRI (e.g., venlafaxine, duloxetine) at the screening visit. Note: Use of SSRIs will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial.
  • The patient is receiving treatment of his/her parkinsonian symptoms with a MAO inhibitor. Note: Patients receiving amantadine, COMT inhibitors, DA agonists and/or anticholinergics will be eligible to enter the trial, provided they are on a stable dose at screening.
  • The patient has received treatment with any agent known to significantly inhibit or induce drug-metabolizing enyzmes (e.g., barbiturates, phenothiazines, etc.) within 4 weeks preceding the screening visit.
  • The patient has received treatment with opioids (e.g., tramadol, meperidine derivatives), in the 4 weeks prior to the screening visit.
  • The patient has received treatment with a depot neuroleptic within one injection cycle, or oral neuroleptics within 4 weeks prior to the screening visit. Patients who are receiving a low dose of an oral neuroleptic for treatment of psychotic symptoms (e.g., hallucinations) related to their Parkinson's disease or anti-parkinsonian medication, and who meet all other entry criteria, will be considered for enrollment, with approval of the CRO Medical Monitor. The Investigator must agree not to increase the dose of the oral neuroleptic during the trial, unless required for significant worsening.
  • The patient has received treatment with a drug that has hepatotoxic potential, e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g, chemotherapy, within one year prior to the screening visit.
  • The patient has a history or a current diagnosis of HIV, 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.
  • The patient has any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG or a diagnostic laboratory test.
  • In the judgment of the Clinical Investigator the patient is likely to be non-compliant or uncooperative during the study.
  • Ophthalmologic history including any of the following conditions: albino patients, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or progressive, severe diabetic retinopathy.

About this study

Official title: A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic

The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations who are currently receiving a stable dose of levodopa.

Being tested
Safinamide, Placebo
Keywords
Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's disease with motor fluctuations
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

  • SafinamideDrug

  • PlaceboDrug

Study groups in NCT01187966
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDrug: Placebo
Receives: Drug: Placebo
High Dose (100mg/day)ExperimentalNot described
Receives: Drug: Safinamide
Low dose (50mg/day)ExperimentalNot described
Receives: Drug: Safinamide

What is being measured

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

  1. Increase in mean daily "on" time

    Increase in mean daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia) during 18-hr diary recording period

    Measured: baseline to endpoint

Secondary outcomes (1)

  1. Decrease in total daily "off" time

    Decrease in total daily "off" time, UPDRS Section III during "on" phase (based on diary) - mean change from baseline to endpoint, CGI - Change from baseline - mean score in the course of the study, change in cognition (cognitive test battery), decrease in mean "off" time following first morning dose of levodopa, improvement in the Dyskinesias Rating Scale during "on" phase, UPDRS Section II during "on" phase (based on diary),CGI- Severity of illness - mean change from baseline to endpoint, mean percent change in levodopa dose

    Measured: baseline to endpoint

Timeline

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

  1. First posted24 Aug 2010 (estimated)
  2. Study startJan 2007
  3. Primary completionOct 2008
  4. Study completionFeb 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
669 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187966
Sponsor's protocol ID
NW-1015/016/III/2006
Status last verified
Aug 2010
First submitted
31 May 2010
Last updated
24 Aug 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Safinamide in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA.

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 7 inclusion and 28 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 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Increase in mean daily "on" time (time frame: baseline to endpoint). 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 NCT01187966.

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 24 Aug 2010.

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