FindTrial
Sign In

A pilot study on the effect of ARA290 on pain and pain responses and retinal edema in patients with diabetes mellitus and neuropathic pain

A pilot study on the effect of ARA290 on pain and pain responses and retinal edema in patients with diabetes mellitus and neuropathic pain

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021518-45-NL
Enrollment
Unknown
Registered
2010-06-25
Start date
2010-07-12
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic pain MedDRA version: 12.1 Level: LLT Classification code 10054095 Term: Neuropathic pain

Interventions

Product Name: ARA290 Product Code: ARA290 Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (i) Patients diagnosed with small-fiber neuropathy according to the guidelines of the IASP or other professional pain societies (eg., Netherlands Society of Anesthesiologists); (ii) a pain score of 5 or higher; (iii) age between 18 and 75 years; (iv) being able to give written informed consent. 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: Female patients that are pregnant or lactating will be excluded.

Design outcomes

Primary

MeasureTime frame
Main Objective: To study the effectiveness of ARA290 in the treatment of pain in neuropathic pain patients;Secondary Objective: -;Primary end point(s): pain relief using a Visual Analogue Score (VAS) sying the 4 weeks of treatment—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026