Clinical trial NCT01028586: MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Idiopathic Parkinson's Disease
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 507
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Week 78
Secondary outcomes:
measure: Proportion of subjects requiring intervention
timeFrame: Week 78
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78
timeFrame: Week 78
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78
timeFrame: Week 78
measure: Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78
timeFrame: Week 78
measure: Clinical Global impression (CGI) - Severity scale score change from baseline to week 78
timeFrame: Week 78
measure: EuroQoL 5D (EQ-5D) score change from baseline to week 78
timeFrame: Week 78
measure: Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78
timeFrame: Week 78
measure: Cogtest® PD battery test score change from baseline to week 78
timeFrame: Week 78
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Enquire Central Contact
Study officials:
affiliation: EMD Serono
name: Jonathan Willmer, MD
role: STUDY_DIRECTOR
References: