The hypothesis is that the novel drug ARA290 is effective in alleviating neuropathic pain caused by small fiber neuropathy in sarcoidosis patients.
ID
Bron
Verkorte titel
Aandoening
- sarcoidosis
- small fiber neuropathy
Ondersteuning
- Leiden University Medical Center, Leiden
- St. Anthonius Hospital, Nieuwegein
- Maastricht University Medical Center, Maastricht
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pain relief by VAS scores (scale 0 (no pain) to 10 (most pain imaiganable) of most pain, least pain and average pain by questionnaire.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The hypothesis is that the novel drug ARA290 is effective in alleviating neuropathic pain caused by small fiber neuropathy in sarcoidosis patients.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Wetenschappelijk
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2934 |
| NTR-old | NTR3081 |
| Ander register | METC : P10-136C |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |