Expired Study
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Boca Raton, Florida


Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.


Inclusion Criteria: 1. Diagnosis of idiopathic Parkinson's Disease of less than 5 years duration, with a Hoehn and Yahr stage of I-III. The diagnosis should be based on medical history and neurological examination. 2. 30 to 80 years, inclusive, at screening. 3. If female, be either post menopausal for at least 2 years, surgically sterilised or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. For the purposes of this study, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive. 4. Receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to the screening visit. 5. Willing and able to participate in the study and have provided written, informed consent. Exclusion Criteria: To be eligible for inclusion in this study the subjects must not meet any of the following criteria: 1. Any indication of forms of Parkinsonism, other than idiopathic Parkinson's Disease. 2. If female, be pregnant or lactating. 3. Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months. 4. Currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations. 5. 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. Subjects with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion. 6. Second- or third-degree atrioventricular 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 significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method. 7. Have received treatment with safinamide previously. 8. Concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug). 9. History of, or current psychosis (e.g. schizophrenia or psychotic depression) or a score ≥ 3 on item 2 (thought disorder) or 3 (depression) of the UPDRS, Section I at screening. 10. Evidence of dementia or cognitive dysfunction, as indicated by a MMSE score < 24 or a score ≥ 3 on item 1 (mentation) of the UPDRS, Section I at screening. 11. Depression, as indicated by a GRID-HAMD (17-item scale) score > 17 at screening. 12. History of allergic response to anticonvulsants or anti-Parkinsonian agents. 13. Mental or physical condition (e.g., neurotic behaviour, crippling degenerative arthritis, or limb amputation), which would preclude performing efficacy or safety assessments. 14. Hypersensitivity or contraindications to MAO B inhibitors. 15. Current history of severe dizziness or fainting on standing, due to postural hypotension. 16. Neoplastic disorder, which is either currently active or has been in remission for less than one year. 17. Participation in a clinical trial within 30 days of entry into the trial (screening visit) or has received treatment with any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to screening. 18. Treatment of their Parkinsonian symptoms with a medication, other than a stable dose of a single dopamine agonist, during the 8 weeks preceding the screening visit. 19. Treatment with any agent known to significantly inhibit or induce drug-metabolising enzymes (e.g., barbiturates, phenothiazines, etc.) within 4 weeks preceding the screening visit. 20. Treatment with opioids (e.g., tramadol, meperidine derivatives), SNRIs (e.g., venlafaxine, duloxetine), tri- or tetra-cyclic antidepressants, MAO inhibitors (e.g. selegiline), in the 8 weeks prior to the screening visit. Dextromethorphan will be permitted if used for treating cough. 21. Treatment with a depot neuroleptic within one injection cycle, or oral neuroleptics within 4 weeks prior to the screening visit. 22. 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. 23. Diagnosis of HIV, or tests positive for Hepatitis C antibodies, or Hepatitis B surface antigen. 24. Any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG or in a diagnostic laboratory test. 25. Ophthalmologic history including any of the following conditions: albino subjects, 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 diabetic retinopathy. 26. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:


Brief Title:

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

Official Title:

A Phase III, Double-blind, Placebo-controlled Randomised Trial 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 Subjects With Early Idiopathic Parkinson's Disease Treated With a Stab

Overall Status:


Study Phase:

Phase 3



Minimum Age:

30 Years

Maximum Age:

80 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Newron Pharmaceuticals S.p.A.

Oversight Authority:

  • United States: Food and Drug Administration
  • Canada: Health Canada

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Intervention Model: Parall

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Jonathan Willmer, MD
Study Director
Merck Serono S.A., Geneva

Study Dates

Start Date:November 2007
Completion Date:March 2012
Completion Type:Actual
Primary Completion Date:January 2012
Primary Completion Type:Actual
Verification Date:March 2013
Last Changed Date:October 28, 2013
First Received Date:December 19, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III).
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate the changes from baseline to W24 in activities of daily living, cognition, change in global clinical status, responder rates with regard to motor symptoms and health related quality of life
Time Frame:24 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Safinamide (as add-on therapy)
Description:Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
Arm Name:1
Other Name:Apokyn
Intervention Type:Drug
Name:Safinamide (as add-on therapy)
Description:Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
Arm Name:2
Other Name:Apokyn
Intervention Type:Drug
Name:Safinamide (as add-on therapy)
Description:Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
Arm Name:3
Other Name:Apokyn

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:50 mg/day Safinamide
Study Arm Type:Active Comparator
Arm Name:2
Description:Safinamide 100mg/day
Study Arm Type:Placebo Comparator
Arm Name:3
Description:Placebo 0mg/Safinamide

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Newron Pharmaceuticals S.p.A.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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