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

Idiopathic Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01028586
• Other study ID #: 27938
• Secondary ID: IND: 63,901
• Status: Terminated
• Phase: Phase 3
• First received: December 7, 2009
• Last updated: March 27, 2013
• Start date: October 2009

Study information

• Verified date: August 2012
• Source: Newron
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBulgaria: Bulgarian Drug AgencyCanada: Health CanadaChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCroatia: Ministry of Health and Social CareCzech Republic: State Institute for Drug ControlEuropean Union: European Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyIndia: Ministry of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMexico: Ministry of HealthPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 507
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

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.
• 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
matching placebo tablets

Locations

Country	Name	City	State
Switzerland	Enquire Central Contact	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Newron

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of subjects requiring intervention		Week 78	No
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78		Week 78	No
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78		Week 78	No
Secondary	Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78		Week 78	No
Secondary	Clinical Global impression (CGI) - Severity scale score change from baseline to week 78		Week 78	No
Secondary	EuroQoL 5D (EQ-5D) score change from baseline to week 78		Week 78	No
Secondary	Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78		Week 78	No
Secondary	Cogtest® PD battery test score change from baseline to week 78		Week 78	No