Research with human participants

Overview of medical research in the Netherlands

Effects of ARA 290 on the regrowth of epidermal nerve fibers in normal volunteers and patients with sarcoidosis

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Last updated:

In this study we will assess the effect of ARA290 on nerve damage by taking 4 skin bipsies during treatment.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Peripheral neuropathies
Study type
Observational invasive

ID

NL-OMON39192

Source

ToetsingOnline

Brief title

Effect of ARA290 on the regrowth of epidermal nerve fibers

Condition

  • Peripheral neuropathies

Synonym

small fiber neuropathie AND

Research involving

Human

Sponsors and support

Primary sponsor :
Leids Universitair Medisch Centrum
Source(s) of monetary or material Support :
Araim Pharmaceuticals.,Araim, Ossining NJ USA

Intervention

Keyword :
ARA290, nerve fibers, regrowth, sarcoidosis

Outcome measures

Primary outcome

Nerve biopsy results

Secondary outcome

Pain scoring

Background summary

Patients with sarcoidosis and suffereing from neuropathy have abnormalties of
thir peripheral nerve endings causing severe pain. ARA290 is a therapy aimed at
restoration of these nerve endings. In this study we will assess the effect of
ARA290 on nerve damage by taking 4 skin bipsies during treatment.

Study objective

In this study we will assess the effect of ARA290 on nerve damage by taking 4
skin bipsies during treatment.

Study design

Double-blind, placebo controled

Study burden and risks

Taken the daily sq injections and 4 biopsies, we consider the burden/risk to be
moderate. No long-term effects are to be expected.

Public
Leids Universitair Medisch Centrum

Albinusdreef 2
Leiden 2333 ZA
NL
Scientific
Leids Universitair Medisch Centrum

Albinusdreef 2
Leiden 2333 ZA
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

sarcoidosis
small fiber neuropathy

Exclusion criteria

BMI >30

Design

Study phase :
2
Study type :
Observational invasive
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
36
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
ARA290
Generic name :
ARA290

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leids Universitair Medisch Centrum (Leiden)
Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leids Universitair Medisch Centrum (Leiden)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Leids Universitair Medisch Centrum (Leiden)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2012-001492-37-NL
CCMO NL40277.058.12