Last reviewed · How we verify
NCT01432587: DFNS01
The Effect of Diflunisal on Familial Transthyretin Amyloidosis: An Open Label Extension Study of "the Diflunisal Trial" (IND 68092), and an Open Label Observational Study on Previously Untreated Patients With Familial Transthyretin Amyloidosis.
trial testing Diflunisal in Amyloidosis in 55 participants. Completed in 1 December 2014.
1 December 2014
Quick facts
| Lead sponsor | Umeå University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 55 |
| Start date | 1 August 2011 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 3 locations across Sweden |
Drugs / interventions tested
- Diflunisal (DIFLUNISAL) — full drug profile →
Conditions studied
- Amyloidosis — all drugs for Amyloidosis →
Sponsor
Umeå University
Who can join
18 and older, any sex, with Amyloidosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Changes in the Kumamoto scale
Time frame: Enrollment, 12 month and annual follow-up
Composite score of the manifestations of the disease (Kumamoto Scale). Results at enrollment will be compared to results at 12 months and annual follow-ups.
Sponsor's own description
An ongoing trial of diflunisal has been closed for enrollment, thus, patients suitable for the study can no longer participate or receive treatment by diflunisal; and patients, who have participated in the trial can not continue their treatment. The investigators want to continue to monitor the effect of the drug on transthyretin (TTR) amyloidosis in an open label observational study. Primary endpoint will be a composite score of the manifestations of the disease (Kumamoto scale) and secondary end points will be measurements of neurological impairment, heart involvement and nutritional status.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01432587
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Amyloidosis
Currently open trials in the same condition.
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- NCT07081646 — A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloido · Phase 1, PHASE2 · recruiting
- NCT07232459 — [18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis · recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
Other Umeå University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01432587 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Umeå University
- Last refreshed: 21 August 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01432587.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing