No registrations found.
ID
Source
Brief title
Health condition
- sarcoidosis
- small fiber neuropathy
Sponsors and support
- Leiden University Medical Center, Leiden
- St. Anthonius Hospital, Nieuwegein
- Maastricht University Medical Center, Maastricht
Intervention
Outcome measures
Primary outcome
Pain relief by VAS scores (scale 0 (no pain) to 10 (most pain imaiganable) of most pain, least pain and average pain by questionnaire.
Secondary outcome
Questionnaires evaluating:
1. Severity of small fiber neuropathy;
2. Severity of malaise;
3. Quality of life;
4. Depressive symptoms.
Background summary
This study is conducted to evaluate the efficiency of ARA290 in alleviating pain in patients with sarcoidosis induced painfull neuropathy and to predict treatment response by quantative sensory testing (QST). Prior to the study, the patients neuropathy status will be evaluated by a QST protocol. Next, patients will be treated with either ARA290 (n=12) or placebo (n=12) three times a week for 4 consecutive weeks. All endpoints are evaluated by questionnaires on a weekly basis, which can be filled in online.
Study objective
The hypothesis is that the novel drug ARA290 is effective in alleviating neuropathic pain caused by small fiber neuropathy in sarcoidosis patients.
Study design
Prior to the study, the patients neuropathy status will be evaluated by a quantative sensory testing protocol. Next, patients are treated with either ARA290 (n=12) or placebo (n=12) three times a week for 4 consecutive weeks. All endpoints are evaluated by questionnaires on a weekly basis, which can be filled in online.
Intervention
Treatment with the novel drug ARA290 three times a week for 4 consecutive weeks. The dose for every treatment day will be 2 mg. The control group will receive a placebo.
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Inclusion criteria
1. Patients diagnosed with sarcoidosis induced small-fiber neuropathy;
2. A pain score of 5 or higher;
3. Age between 18 and 75 years;
4. Being able to give written informed
consent.
Exclusion criteria
1. Pregnancy;
2. Use of erythropoeitin;
3. Current use of anti-TNF or use within the passed six months;
4. Unable to give written informed consent.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL2934 |
| NTR-old | NTR3081 |
| Other | METC : P10-136C |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |