medication overuse headache MedDRA version: 9.1 Level: LLT Classification code 10013753 Term: Drug withdrawal headache MedDRA version: 9.1 Level: HLGT Classification code 10019231 Term: Headaches
Conditions
Interventions
Trade Name: DEPAKIN
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Valproic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pro
Sponsors
UNIVERSITA' DEGLI STUDI DI PERUGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects, both genders, aged 18-60 years (inclusive) at study entry - Subject, has an established history of episodic migraine without aura in the past; - Subject has an average of at least 15 days per month with headache during the last 3 months preceding the entry into the study; - Headache fulfils ICHD-IIR criteria for MOH (see Appendix 1); -If the medication overused is a simple analgesic the included subject must have used this symptomatic drug on > 15 days per month, for at least 3 months. If the medication overused is a triptan, or a combination of analgesic or a combination of acute medications, the included subject must have used the above drugs on > 10 days per month, for at least 3 months. (see Appendix 2); - Subject judged to be reliable and agreeable to keeping all appointments for clinic visits, tests, and procedures required by the protocol. - Subject, or their legal representatives, must have signed and dated the informed consent; - A female is eligible to enter and participate in this study if she is: a) non-childbearing potential i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal (> 1 year since last menstrual cycle ), had a documented tubal ligation or is surgically sterilized); b) childbearing potential, has a negative pregnancy test ?urine (at screening), and agree to one of the following: 1. Complete abstinence from intercourse from 2 weeks prior to administration the investigational product, throughout the treatment period and for a minimum of one week after completion or premature discontinuation from investigational product. 2. Consistent and correct use of an acceptable method of birth control 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: - Subject has taken a headache-prevention medication during the month preceding enrolment in the trial. - Known allergy, sensitivity or intolerance to study drugs and/or study drugs? formulation ingredients; - Known allergic reactions to drugs; - Subject used prohibited concomitant therapy [other antiepileptics; barbiturates; antidepressants; some antibatterial drugs (Carbapenem, Panipenem, Meropenem, Imipenem and Erythromycin); anticoagulants; Neuroleptics; Zidovudine, Mefloquine, cytostatics, Cimetidine, Colestiramine, and chronic use of Acetyl-salicylic Acid and benzodiazepines]; - Subject has a history or suspicion of alcohol abuse or illicit drug use in the past 2 years; - Subject has a history of poor compliance with past drug therapies, or is felt to be at risk of non-compliance (for taking study medication or for completing the diary) as judged by the Investigator; - Subject is pregnant or breastfeeding female. For women with childbearing potential, absence of pregnancy must be confirmed by a pregnancy test at study entry; - Subject is female of childbearing potential without adequate contraception; - Subject with a past or present history of a serious illness, which as judged by the Investigator, may affect the outcome of this study. These diseases, in the six months prior the screening, include: liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), metabolic disturbances; - Clinically significant abnormalities in safety laboratory analysis at the Screening Visit. Particularly any liver function test (including ALT, AST and ALP) > 1.5 x upper limit normal (ULN) at the screening visit; - Subject is concurrently participating in another clinical study or investigational drug trial or has participated within the previous 30 days in an investigational drug study or is planning to participate in another drug or device study at any time during the study (screening through follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of a short-term (12-week) treatment with sodium valproate at the dosage of 800 mg/die compared with placebo in reducing the number of days with headache in patients with medication-overuse headache following a 6-day out-patient detoxification regimen.;Secondary Objective: To evaluate the effect of sodium valproate at the dosage of 800 mg/die on psychopathological disturbances complained by MOH patients compared with placebo using ad hoc scales and questionnaires. To determine treatment satisfaction in patients treated with sodium valproate as prophylactic agent compared with patients treated with placebo To investigate the safety and tolerability of sodium valproate at the dosage of 800 mg per day compared with placebo using various clinical endpoints in the preventive treatment of MOH after a detoxification regimen;Primary end point(s): Change in the number of days with headache/month (decrease ≥50%) versus the baseline phase (4 weeks without preventive treatment. Responders will be defined as those having a ≥ 50% reduction in headache days/month. | — |
Countries
Italy
Outcome results
None listed