Patients with Fibromyalgia-syndrome
Conditions
Interventions
Trade Name: Somsanit
Product Name: Somsanit
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Sodium-4-hydroxybutanoic acid
CAS Number: 591-81-1
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Charitè Universitätmeditin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ACR-criteria of Fibromalgia-Syndrome female Age 18-80 containment of german language motivation of therapy written acceptance of the patient 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: gravidity psychiatric-diseased person taking sedated drugs (including opiate) desire of pension persons under 18 and over 80 years persons, who are unable to consent instable arterial hypertension epilepsy seriously interference of renal function alcoholintoxication taking opiate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of pain measured by consultation within 12 month and MPI score;Secondary Objective: The secondary objective parameters serve the evaluation of the pathological mechanism and factors of a possible effect of Gamma-Hydroybuterate in Fibromyalgia (measured by physiological parameters life-control and affective depressive mood, by laboratory parameters growth hormone, IGF1, ACTH and Cortisol as well as the physiological parameters pain threshold, muscletension, blood pressure dermisconductance and heardrate.;Primary end point(s): conditional-painful damnification, measured by the MPI and the visites of a doctor for the least 12 month | — |
Countries
Germany
Outcome results
None listed