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:
Newron Pharmaceuticals S.p.A.
Information provided by (Responsible Party):
Newron Pharmaceuticals S.p.A.
ClinicalTrials.gov Identifier:
NCT01028586
First received: December 7, 2009
Last updated: March 27, 2013
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Pharmaceuticals S.p.A.:
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:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Newron Pharmaceuticals S.p.A. |
| 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 Publica 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 Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders |
Neurodegenerative Diseases Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013