NCT01142154 is a Phase 1/Phase 2 clinical trial of Prodarsan in Cockayne Syndrome, sponsored by DNage B.V..

Who is sponsoring NCT01142154?

NCT01142154 is sponsored by DNage B.V..

What drugs are being tested in NCT01142154?

Interventions in NCT01142154: Prodarsan.

What condition does NCT01142154 study?

NCT01142154 studies Cockayne Syndrome.

Is NCT01142154 still recruiting?

NCT01142154 is currently completed. Last updated 22 June 2011.

Last reviewed 2011-06-22 · How we verify

NCT01142154

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I/II Crossover Study To Evaluate and Compare the Pharmacokinetics of a Single IV Dose of D-Mannitol (Osmitrol®10%) to Single and Multiple, Escalating Doses of Liquid, Oral Prodarsan™ in Patients With Cockayne Syndrome

Completed Phase 1/Phase 2 Last updated 22 June 2011

What this trial tests

Phase 1/Phase 2 trial testing Prodarsan in Cockayne Syndrome in 5 participants. Completed in 1 February 2011.

Timeline

1 June 2010

Primary endpoint
1 September 2010

1 February 2011

Quick facts

Lead sponsor	DNage B.V.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Enrollment	5
Start date	1 June 2010
Primary completion	1 September 2010
Estimated completion	1 February 2011
Sites	1 location across United States

Drugs / interventions tested

Prodarsan — full drug profile →

Conditions studied

Cockayne Syndrome — all drugs for Cockayne Syndrome →

Sponsor

DNage B.V. — full company profile →

Who can join

Adults 2 to 10, any sex, with Cockayne Syndrome. 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.

Evaluate and compare the pharmacokinetics of D-mannitol following a single IV dose of Osmitrol to single and multiple oral doses of Prodarsan in pediatric patients with Cockayne Syndrome
Time frame: 6 months

Sponsor's own description

This study is to compare the exposure of orally administered Prodarsan to the intravenous dosed Osmitrol (10% solution) in Cockayne Syndrome (CS) patients. Also the pharmacokinetics of single and multiple orally dosed Prodarsan will be evaluated and compared to intravenous dose of Osmitrol in CS patients.

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:

Other recruiting trials for Cockayne Syndrome

Currently open trials in the same condition.

NCT05484570 — Natural History Study for DNA Repair Disorders · recruiting
NCT03047369 — The Myelin Disorders Biorepository Project · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01142154 (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 DNage B.V.
Last refreshed: 22 June 2011

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/NCT01142154.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing