E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 elucidate Memantines actions in brain of patients with Parkinson's disease.
Administer MEMANTINE for 6 weeks (3 weeks uptitration to final dose of 2x10 mg daily to be administered in week 4, 5 and 6) to patients with Parkinson's Disease. Using PET methodology we wish to evaluate changes in:
1) Regional cerebral cortical oxidative metabolism (rCMRO2) before and after trial of Memantine. 2) Regional basal ganglia oxidative metabolism (rCMRO2) before and after trial of Memantine. 3) Regional cerebral blood flow (rCBF) before and after trial of Memantine. 4) Dopamine metabolism before and after trial of Memantine. |
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E.2.2 | Secondary objectives of the trial |
UPDRS score improvements in patients with Parkinson's Disease after 6 weeks treatment with memantine. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients: 1) Idiopathic Parkinson's Disease (ICD-10: G20.9) 2) Age 50-70
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E.4 | Principal exclusion criteria |
Patients:
1) Any current use of tobacco substances containing nicotine. 2) Conditions prohibiting MR scan (implanted pacemaker, protheses etc.) 3) Brain diseases apart from Parkinson's Disease (Aneurisms, AV-malformations, stroke, cranial trauma, dementia etc.) 4) Psychiatric disorders (Schizophrenia, bi-polar mood disorder, depression) 5) Other major diseases (heartfailure, arhytmias, infarcts, kidney failure, liver failure, cirrhosis, active hepatitis, portal hypertension etc.) 6) Current use of drugs with major influence on CNS (eg. amphetamine, metamphetamine, cocaine, opioids, antipsychotics, antiepileptics, NMDA-antagonists) 7) Current use of the anti-parkinsonian drugs Cabergolin and Amantadine. 8) Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Using PET tracers (15O Oxygen, 15O H2O, F-DOPA) we wish to evaluate the changes in:
1) Regional oxidative metabolism (rCMRO2) in cortex and basal ganglia before and after trial of Memantine. 2) Regional cerebral blood flow (rCBF) before and after trial of Memantine. 3) Dopamine metabolism before and after trial of Memantine. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Last visit of the last subject. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |