Back to resultsMOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918) (MOTION)
Primary Purpose
Idiopathic Parkinson's Disease
Status
Terminated
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Safinamide, MAO-B inhibitor
Safinamide, MAO-B inhibitor
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- The subject completed 24 weeks of Trial 27918.
- The subject successfully completed all trial requirements in Trial 27918.
- If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, 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".
- Subject is willing and able to participate in the trial and has provided written, informed consent
Exclusion Criteria:
- If female, the subject is pregnant or lactating.
- The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
- The subject has shown clinically significant deterioration during participation in Trial 27918.
- Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
- The investigator deems it is not in the subject's best interest to participate to trial 27938
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Sites / Locations
- Enquire Central Contact
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Number of Cycles: until progression or unacceptable toxicity develops.
Number of Cycles: until progression or unacceptable toxicity develops.
Placebo
Outcomes
Primary Outcome Measures
Time from baseline to first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy
Secondary Outcome Measures
Proportion of subjects requiring intervention
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78
Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78
Clinical Global impression (CGI) - Severity scale score change from baseline to week 78
EuroQoL 5D (EQ-5D) score change from baseline to week 78
Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78
Cogtest® PD battery test score change from baseline to week 78
Full Information
NCT ID
NCT01028586
First Posted
December 7, 2009
Last Updated
March 27, 2013
Sponsor
Newron Pharmaceuticals SPA
1. Study Identification
Unique Protocol Identification Number
NCT01028586
Brief Title
MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)
Acronym
MOTION
Official Title
A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newron Pharmaceuticals SPA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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, extension trial, 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 objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
507 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Number of Cycles: until progression or unacceptable toxicity develops.
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Number of Cycles: until progression or unacceptable toxicity develops.
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Safinamide, MAO-B inhibitor
Intervention Description
Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
Intervention Type
Drug
Intervention Name(s)
Safinamide, MAO-B inhibitor
Intervention Description
Safinamide, MAO-B inhibitor 100 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablets
Primary Outcome Measure Information:
Title
Time from baseline to first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy
Time Frame
Week 78
Secondary Outcome Measure Information:
Title
Proportion of subjects requiring intervention
Time Frame
Week 78
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78
Time Frame
Week 78
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78
Time Frame
Week 78
Title
Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78
Time Frame
Week 78
Title
Clinical Global impression (CGI) - Severity scale score change from baseline to week 78
Time Frame
Week 78
Title
EuroQoL 5D (EQ-5D) score change from baseline to week 78
Time Frame
Week 78
Title
Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78
Time Frame
Week 78
Title
Cogtest® PD battery test score change from baseline to week 78
Time Frame
Week 78
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject completed 24 weeks of Trial 27918.
The subject successfully completed all trial requirements in Trial 27918.
If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, 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".
Subject is willing and able to participate in the trial and has provided written, informed consent
Exclusion Criteria:
If female, the subject is pregnant or lactating.
The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
The subject has shown clinically significant deterioration during participation in Trial 27918.
Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
The investigator deems it is not in the subject's best interest to participate to trial 27938
Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Willmer, MD
Organizational Affiliation
EMD Serono
Official's Role
Study Director
Facility Information:
Facility Name
Enquire Central Contact
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)
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