E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple System Atrophy of the Parkinsonian subtype (MSA-P) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064060 |
E.1.2 | Term | Multiple system atrophy |
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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 |
To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: Sottostudio RM (nel protocollo principale) x determinare velocita` di progressione delle anormalita` di alcune regioni cerebrali e delle modifiche strutturali nel putamen e nel tronco cerebrale
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E.3 | Principal inclusion criteria |
1.Subjects over 30 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) according to The Gilman Criteria (2008). 2.Subjects who are less than 3 years from the time of documented MSA diagnosis. 3.Subjects with an anticipated survival of at least 3 years in the opinion of the investigator. 4.Subjects who are willing and able to give informed consent. Subjects who are not able to write may give verbal consent in the presence of at least one witness, and the witness should sign the informed consent form. Imaging Substudy inclusion criteria All subjects from sites participating in the substudy who are willing and able to give informed consent for this substudy. Subjects who are not able to write may give verbal consent in the presence of at least one witness, and the witness should sign the informed consent form. |
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E.4 | Principal exclusion criteria |
1.Subjects receiving treatment with midodrine or other sympathomimetics within 4 weeks prior to baseline visit. 2.Subjects with severe orthostatic symptoms as assessed by a score of ≥ 3 on UMSARS question 9. 3.Subjects who meet any of the following criteria which tend to suggest advanced disease: a.Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1 b.Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2 c.Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7 d.Falling more frequently than once per week as assessed by a score of ≥ 3 on UMSARS question 8 4.Subjects taking disallowed medications according to the locally approved Azilect label. 5.Subjects taking MAO inhibitors within 3 months prior to baseline visit. 6.Subjects with hypertension whose blood pressure, in the investigator s opinion, is not well controlled. 7.Subjects who, based on the investigator s judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Subjects with moderate or severe hepatic impairment. 8.Subjects who have taken any investigational products within 60 days prior to baseline. 9.Women of child-bearing potential who do not practice an acceptable method of birth control [acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner s vasectomy, a double-protection method (condom or diaphragm with spermicide)]. 10.Pregnant or nursing women. Imaging Substudy exclusion criteria Any condition which would make the subject, in the opinion of the investigator, unsuitable for an MRI study (e.g. pacemakers; medical or bio-stimulation implants which are contraindicated for MRI scans and which may include vagus nerve stimulators, implantable cardioverter-defibrillators, loop recorders, insulin pumps, cochlear implants). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint: Change from baseline to Week 48/Termination visit in the total UMSARS score (the total UMSARS score is defined as the sum of Parts I + II) |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 20 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |