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

This study has been terminated.
(Trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals)
Sponsor:
Information provided by (Responsible Party):
Newron
ClinicalTrials.gov Identifier:
NCT01028586
First received: December 7, 2009
Last updated: March 27, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: Safinamide, MAO-B inhibitor
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Newron:

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 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects requiring intervention [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • Clinical Global impression (CGI) - Severity scale score change from baseline to week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • EuroQoL 5D (EQ-5D) score change from baseline to week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • Cogtest® PD battery test score change from baseline to week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]

Enrollment: 507
Study Start Date: October 2009
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Arm 2
Number of Cycles: until progression or unacceptable toxicity develops.
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028586

Locations
Switzerland
Enquire Central Contact
Geneva, Switzerland
Sponsors and Collaborators
Newron
Investigators
Study Director: Jonathan Willmer, MD EMD Serono
  More Information

No publications provided

Responsible Party: Newron
ClinicalTrials.gov Identifier: NCT01028586     History of Changes
Other Study ID Numbers: 27938, IND: 63,901
Study First Received: December 7, 2009
Last Updated: March 27, 2013
Health Authority: Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
European Union: European Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
India: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: Ministry of Health
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Dopamine Agonists
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014