A Phase IIa, double-blind, placebo-controlled, randomised, parallel-group study, to investigate the safety, tolerability and anxiolytic effect of the mGluR5 negative allosteric modulator ADX10059 in patients with dental anxiety undergoing dental treatment.
- Conditions
- Dental anxiety
- Registration Number
- EUCTR2006-003912-23-GB
- Lead Sponsor
- Addex Pharmaceuticals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Safety and tolerability of ADX10059<br><br>Evaluation of the effect of ADX10059 on an anxiety visual analogue scale (VAS) at various time points<br><br>Evaluation of the effect of ADX10059 on physiological parameters of anxiety (skin conductance)<br><br>Patient evaluation of study medication effectiveness.;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.
- Secondary Outcome Measures
Name Time Method