E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Parkinson's Disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the change from baseline to W78 in dyskinesia using the Dyskinesia Rating Scale during the “on” phase, comparing safinamide (50-100 mg/day) to placebo. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the changes from baseline to W78 in motor fluctuations, motor function, activities of daily living, quality of life, change in global clinical status, change in levodopa dose, and cognition.
Evaluate the changes from baseline to W78 in depression, disease staging, cognition and Health Resource Utilization. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria: 1. The subject completed 24 weeks of treatment in trial 27919. 2. The subject successfully completed all trial requirements in trial 27919. 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 Section 6.4.9 of the protocol for four weeks prior to, during and four weeks after the last dose of study 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. 5. Be able to maintain an accurate and complete diary (18-hour), with the help of a caregiver, recording “on” time, “on” time with minor dyskinesia, “on” time with troublesome dyskinesia, “off” time and time asleep.
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E.4 | Principal exclusion criteria |
To be eligible for inclusion in this trial the subjects must not meet any of the following criteria: 1. If female, the subject is pregnant or lactating. 2. The subject experienced a clinically significant adverse effect during trial 27919 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 27919. 4. Motor deterioration during trial 27919 that requires 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 27937. 6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
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E.5 End points |
E.5.1 | Primary end point(s) |
Dyskinesia Rating Scale score during the “on” phase change from baseline to W78 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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For administrative and safety reporting purposes the end of the trial will be defined as the date of the final clinical database lock. This provides for a single and conservative definition across all trial sites. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |