Complex regional pain syndrome
Conditions
Interventions
Product Name: ARA 290
Product Code: ARA 290
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Innate repair activator peptide
Current Sponsor code: ARA290
Concentration unit:
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Continuing pain, which is disproportionate to any inciting event; (2) Must report at least one symptom in three of the four following categories: a. Sensory: reports of hyperesthesia and/or allodynia; b. Vasomotor: reports of temperature asymmetry and/or skin color changes and/or color asymmetry; c. Sudomotor/edema: reports of edema and/or sweating changes and sweating asymmetry; d. Motor/trophic: reports of decreased motor ranges and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin); (3) Must display at least one sign at time of evaluation in two or more of the following categories: a. Sensory: hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement); b. Vasomotor: evidence of temperature asymmetry and/or skin color changes and/or color asymmetry; c. Sudomotor/edema: evidence of edema and/or sweating changes and sweating asymmetry; d. Motor/trophic: evidence of decreased motor ranges and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin); (4) There is no other diagnosis that better explains the signs and symptoms. (5) Pharmacotherapy for CRPS symptoms (e.g., analgesics, antidepressants, and/or anticonvulsants ) has been stable for at least 4 weeks 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Inability to give informed consent; • Patients suffering from other pain syndromes; • Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator); • A semi recumbent systolic blood pressure of >160 mmHg and/or diastolic blood pressure of > 95 mmHg at screening; • History of alcoholism or substance abuse within three years prior to screening; • Positive pregnancy test or lactation • Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week; • Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; • Subjects that received a vaccination or immunization within the last month; • Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year; • Subject has undergone major surgery within three months prior to screening; • Inability or unwillingness to self-administer ARA 290 via subcutaneous injections • Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, and ability of subcutaneously administered ARA 290 to reduce pain, assessed by Numerical Rating Score of "pain now" and Global Health self-assessment, during and after 4 weeks of treatment with ARA 290 or placebo;Secondary Objective: • Assess the predictive effect of sensory tests as determined by quantitative sensory testing (QST, for example deep muscle pressure pain threshold) on the efficacy of treatment; • Assess the effect of ARA 290 treatment on quality of life and overall mood-related parameters; • Assess the effect of ARA 290 on daily functioning ;Primary end point(s): The main study end-point is: • Change in Numerical Rating Score of “pain now” as reported at the end of each treatment week and at the end of each week in the 4 weeks following treatment. • Global Health self-assessment ;Timepoint(s) of evaluation of this end point: Pre-treatment and at the end of each week for the four weeks of treatment and continuing weekly for an additional 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional endpoints are: • Change in Brief Pain Inventory • Change in Short Form-36 questionnaire • Change in Radboud Skills Questionnaire • Change in the Walking Ability questionnaire • Change in Hospital Anxiety and Depression Scale • Change in Pain Coping Inventory • Change in analgesic/antidepressant use ;Timepoint(s) of evaluation of this end point: Pre-treatment and at the end of each week for the four weeks of treatment and continuing weekly for an additional 4 weeks. | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Leiden University Medical Center
Outcome results
None listed