E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cerebrospinal fluid circulation disorder seen in the following clinical disease states: Communicating hydrocephalus, idiopathic intracranial hypertension, idiopathic intracranial hypotension, intracranial cysts (cerebral cysts and arachnoid cysts). |
|
E.1.1.1 | Medical condition in easily understood language |
Clinical conditions with abnormal brain water circulation. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 determine distribution of contrast agent as assessed by repeated cranial MRI. |
|
E.2.2 | Secondary objectives of the trial |
Compare site of blockade of cerebrospinal fluid circulation in different disease states. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients between 18 and 80 years of age.
Patients who are assessed for the following clinical states:
- Communicating hydrocephalus,
- Idiopathic intracranial hypertension,
- Idiopathic intracranial hypotension,
- Intracranial cysts (cerebral cysts and arachnoid cysts). |
|
E.4 | Principal exclusion criteria |
- Patients with contrast allergy
- Patients with renal failure.
- Patients < 18 years of age, or >80 years of age.
- Pregnant women, or women who are breastfeeding. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time-dependent appearance and disappearance of contrast agent in brain, as revealed by repetitive MRI, following intrathecal administration.
A contrast-clearance curve is created for each individual patient. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After a single intrathecal injection of contrast agent, MRI is done after 0-2 hours, and after 4, 6, 8, and 24 hours. |
|
E.5.2 | Secondary end point(s) |
Differences in distribution of contrast agent between patients with different kinds of CSF circulation disturbance. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After a single intrathecal injection of contrast agent, MRI is done after 0-2 hours, and after 4, 6, 8, and 24 hours. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
Clinical control 12 months after intrathecal contrast agent administration. |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |