E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
The primary purpose of this study is to assess how effective ADX10059 is at reducing anticipatory anxiety, when administered before a scheduled dental procedure, compared to placebo. |
|
E.2.2 | Secondary objectives of the trial |
Safety and tolerability of ADX10059
Evaluation of the effect of ADX10059 on an anxiety visual analogue scale (VAS) at various time points
Evaluation of the effect of ADX10059 on physiological parameters of anxiety (skin conductance)
Patient evaluation of study medication effectiveness. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male or female patients aged 18 to 65 years inclusive.
2.Patients who score between 12 and 23 (inclusive) on a Modified Dental anxiety scale at screening.
3.Patients who have a scheduled appointment for an elective dental procedure (dental treatment is not to last more than 1.5 hours).
4.Ability to communicate well with the study staff and to comply with the requirements of the entire study.
5.Patients who provide written informed consent to participate in this study |
|
E.4 | Principal exclusion criteria |
1.Current diagnosis of significant co-existing psychiatric disorder i.e. one that requires medication such as antidepressant, antipsychotic medications and anxiolytics.
2.Food intake less than two hours before dosing (i.e. the patient has fasted for 2 hours prior to dosing).
3.Patients with known clinically significant allergy or known hypersensitivity to drugs that, in the opinion of the Investigator, may affect the patient’s safety.
4.Patients who have significant abnormal laboratory parameters at Screening, in particular, liver or renal functions tests greater than twice the upper limit of normal or any other clinically significant biochemical or haematological abnormality as determined by the Investigator.
5.Women who are pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device [IUD], intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening (Visit 1) and prior to dosing on the Treatment Day (Visit 2).
6.Patients who are regular users of recreational drugs (in particular benzodiazepines, amphetamine, metamphetamine, cocaine and opiates) or any sedatives, and who have used them within 14 days before Screening (Visit 1).
7.Patients with a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
8. Patients taking sodium valproate or valproic acid or patients who have taken either of these within the last 30 days.
9. Administration of any investigational drug up to 30 days before study entry. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable of this study is the comparison of VAS-Anxiety score at 60 minutes post dose (immediately before dental treatment): ADX10059 versus placebo. |
|
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 | 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 | 6 |
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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |