A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF THE MGLUR5 NEGATIVE ALLOSTERIC MODULATOR ADX10059 IN THE ACUTE TREATMENT OF MIGRAINE

Phase 1

• Conditions: Migraine with or without aura; MedDRA version: 8.1Level: PTClassification code 10027599

• Registration Number: EUCTR2006-001488-51-DE
• Lead Sponsor: Addex Pharmaceuticals S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-01
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Female and male patients aged 18 to 65 years.
2.Diagnosis of migraine with or without aura according to IHS criteria 1.1 and 1.2.1
3.Onset of migraine history prior to age 50 years
4.Patients who have between 2 and 8 moderate or severe migraine headaches per month.
5.Ability to communicate well with the study staff and to comply with the requirements of the entire study.
6.Patients who have provided 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

Exclusion Criteria

1.Administration of any investigational drug up to 30 days before study entry or parallel participation in another study
2.Patients with more than 15 headache days per month.
3.Patients with known clinically significant allergy or known hypersensitivity to ADX10059 or lactose.
4.Patients who have 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 hematological abnormality as determined by the investigator.
5.Patients with a history of a significant medical or psychiatric condition that may affect the safety of the patient or preclude adequate participation in the study.
6.Patients who are pregnant or breast-feeding. Female patients who are of child bearing potential must be using adequate contraceptive methods (e.g. oral contraceptives, intra uterine device (IUD), double barrier method (e.g. spermicide plus condom or diaphragm plus spermicide) and intra muscular hormonal contraceptive).
7.Patients using migraine prophylaxis must have been on stable doses of the prophylactic agent for least 12 weeks prior to study entry.
8. Patients taking sodium valproate or valproic acid or patients who have taken either of these within the last 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified