MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918) (MOTION)

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

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.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Safinamide, MAO-B inhibitor; Drug: Safinamide, MAO-B inhibitor

• Study Type: Interventional
• Enrollment (Actual): 507
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Enquire Central Contact

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject completed 24 weeks of Trial 27918.
2. The subject successfully completed all trial requirements in Trial 27918.
3. 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".
4. Subject is willing and able to participate in the trial and has provided written, informed consent

Exclusion Criteria:

1. If female, the subject is pregnant or lactating.
2. The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
3. The subject has shown clinically significant deterioration during participation in Trial 27918.
4. Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
5. The investigator deems it is not in the subject's best interest to participate to trial 27938
6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1; Number of Cycles: until progression or unacceptable toxicity develops.	Drug: Safinamide, MAO-B inhibitor; Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.; Drug: Safinamide, MAO-B inhibitor; Safinamide, MAO-B inhibitor 100 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
ACTIVE_COMPARATOR: Arm 2; Number of Cycles: until progression or unacceptable toxicity develops.	Drug: Safinamide, MAO-B inhibitor; Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.; Drug: Safinamide, MAO-B inhibitor; Safinamide, MAO-B inhibitor 100 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
PLACEBO_COMPARATOR: Arm 3; Placebo	Drug: Placebo; matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Week 78

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects requiring intervention	Week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78	Week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78	Week 78
Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78	Week 78
Clinical Global impression (CGI) - Severity scale score change from baseline to week 78	Week 78
EuroQoL 5D (EQ-5D) score change from baseline to week 78	Week 78
Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78	Week 78
Cogtest® PD battery test score change from baseline to week 78	Week 78

Collaborators and Investigators

• Sponsor: Newron Pharmaceuticals SPA
• Investigators: Study Director: Jonathan Willmer, MD, EMD Serono

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (ESTIMATE): December 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 27938; IND: 63,901