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

NCT01028586 | Terminated Phase 3 DMC

• 2 other identifiers: 27938IND: 63,901
• Study Type: interventional
• Target: 507
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Number of Cycles: until progression or unacceptable toxicity develops.

Drug: Safinamide, MAO-B inhibitor

Arm 2

ACTIVE COMPARATOR

Number of Cycles: until progression or unacceptable toxicity develops.

Drug: Safinamide, MAO-B inhibitor

Arm 3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Safinamide, MAO-B inhibitor DRUG

Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.

Arm 1

Placebo DRUG

matching placebo tablets

Arm 3

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newron Pharmaceuticals SPA: lead

Study Sites (1)

Enquire Central Contact

Geneva, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

safinamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jonathan Willmer, MD

  EMD Serono

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2012
• Last Updated: March 29, 2013

Record last verified: 2012-08

Locations

CH (1)