A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 for the prevention of migraine
- Conditions
- MigraineMedDRA version: 9.1Level: LLTClassification code 10027599Term: Migraine
- Registration Number
- EUCTR2008-005481-30-GB
- Lead Sponsor
- Addex Pharma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
A patient will be invited to participate if he/she meets the following inclusion criteria:
1. is willing and able to provide written informed consent
2. is male or female and aged 18 to 65 years, inclusive
3. has a history of migraine, with or without aura for at least 1 year according to the
International Headache Society (IHS) diagnostic criteria
4. was aged = 50 years at onset of migraine history
5. has an historical migraine attack frequency of = 2 moderate/severe (IHS Grade
2/3) attacks per month in the previous 3-6 months
6. has = 3 moderate/severe (IHS Grade 2/3) migraine attacks or 5 migraine
headache days in the 4 week baseline period, as confirmed from the eDiary data
recorded on Days -28 to -1 inclusive
7. has an ability to communicate well with the study staff and to comply with the
requirements of the entire study including compliance with eDiary completion
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
A patient will be excluded from study participation if he/she meets any of the
following criteria:
1. suffers from cluster headaches or chronic migraine headaches
2. currently uses, or within 3 months of Screening, has used:
a. sodium valproate or topiramate
b. any other drugs used specifically for migraine prophylaxis, for example
beta-blockers, calcium channel blockers, tricyclic antidepressants
(TCAs), selective serotonin reuptake inhibitors (SSRIs)
3. has a total of > 10 headache days requiring treatment with a triptan or > 15
headache days, irrespective of whether any treatment is required (including nonsteroidal
anti-inflammatory drug [NSAID] or other analgesics), in the baseline
period, as confirmed from the eDiary data recorded on Days -28 to -1 inclusive
4. is unable to distinguish migraine headache from tension and other types of
headache
5. has been non-responsive to > 1 other prophylactic migraine treatment
6. has a current history of psychiatric disorder requiring regular medication, for
example SSRIs, selective noradrenaline reuptake inhibitors (SNRIs), TCAs and
antipsychotic agents or, that in the opinion of the Investigator, could interfere with
the conduct of the study
7. is an habitual user of recreational drugs (including amphetamine,
methamphetamine, cocaine and opiates), or has a positive test for selected drugs
of abuse at Screening
8. has a known history of alcohol abuse
9. has a known clinically significant allergy or known hypersensitivity to drugs that,
in the opinion of the Investigator, may affect the patient’s safety
10. has clinically significant abnormal laboratory parameters at Screening, in
particular, liver or renal functions tests greater than twice the upper limit of normal
(ULN) or any other clinically significant biochemical or haematological
abnormality as determined by the Investigator
11. has known or suspected human immunodeficiency virus (HIV) or hepatitis B or C
12. has a history of a significant medical condition that may affect the safety of the
patient or preclude adequate participation in the study
13. is pregnant or breast-feeding. Female patients who are of child-bearing potential
must be using adequate contraceptive methods with a low failure rate of less than 1% a year (e.g. oral contraceptive, some intra-uterine devices, intra-muscular hormonal contraceptive), and
have a negative pregnancy test at Screening and prior to randomisation on Day 1
14. has received any investigational drug within 30 days of Screening or any
migraine prophylactic investigational drug within 3 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method