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Treatment of ARA290 in neuropathic pain patients.


- candidate number10393
- NTR NumberNTR3081
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-sep-2011
- Secondary IDsP10-136C METC
- Public TitleTreatment of ARA290 in neuropathic pain patients.
- Scientific TitleEffectiveness of ARA290 on pain relief in sarcoidosis patients with small-fiber neuropathy: A randomized controlled trial.
- ACRONYMARA290 trial
- hypothesisThe hypothesis is that the novel drug ARA290 is effective in alleviating neuropathic pain caused by small fiber neuropathy in sarcoidosis patients.
- Healt Condition(s) or Problem(s) studiedSarcoidosis, Small fiber neuropathy
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2011
- planned closingdate1-jan-2012
- Target number of participants24
- InterventionsTreatment 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.
- Primary outcomePain relief by VAS scores (scale 0 (no pain) to 10 (most pain imaiganable) of most pain, least pain and average pain by questionnaire.
- Secondary outcomeQuestionnaires evaluating:
1. Severity of small fiber neuropathy;
2. Severity of malaise;
3. Quality of life;
4. Depressive symptoms.
- TimepointsPrior 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC), Sint Antonius Ziekenhuis, Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Araim Pharmaceuticals, New York, US
- PublicationsN/A
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD27-sep-2011 - 18-okt-2011


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