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Prodarsan

Phase 1

Cockayne Syndrome | Small molecule | Rare Disease |Pharming Group N.V.|Last Updated: Jun 23, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

Prodarsan · 1 trial · 1 indication

Phase 1 1
NCT01142154Pharmacokinetics and Safety Study of Single and Multiple Oral Doses Prodarsan™ in Patients With Cockayne SyndromeCockayne Syndrome
COMPLETED5 Analytics
PHASE1COMPLETED
Pharmacokinetics and Safety Study of Single and Multiple Oral Doses Prodarsan™ in Patients With Cockayne Syndrome
Cockayne Syndrome
NCT011421545
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Study Endpoints

Primary Endpoints

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
6 months

Secondary Endpoints

Evaluate the safety and tolerability of administering oral Prodarsan in CS patients over a six (6) to eight (8) day period, including dose escalation to reach a Target Dose
6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
oral, liquid solutionEXPERIMENTAL -

Interventions

NameTypeDescription
ProdarsanDRUGProdarsan TID, oral solution, 6-8 days
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Eligibility Criteria

Age Range2 Years to 10 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Parents or legal guardian(s) of the pediatric patient with CS must be willing and able to give written Informed Consent. Informed Assent will be offered to children who can understand and participate in the Informed Assent process. * Diagnosis of CS confirmed by one of the fol...

Countries:United States
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Frequently asked questions about Prodarsan

What is Prodarsan used for?

Prodarsan is an investigational small molecule being developed for the treatment of Cockayne Syndrome, a rare genetic disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Prodarsan?

Prodarsan is being developed by Pharming Group N.V., a biopharmaceutical company listed on the stock exchange under the ticker PHAR. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of the drug.

What phase is Prodarsan in?

Prodarsan is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It is not yet approved for any use, and further clinical trials would be needed to establish its safety and efficacy.

What clinical trials is Prodarsan in?

Prodarsan has been studied in one clinical trial, identified as NCT01142154. This was a Phase 1 study titled 'Pharmacokinetics and Safety Study of Single and Multiple Oral Doses Prodarsan™ in Patients With Cockayne Syndrome,' which has been completed.

Is Prodarsan FDA approved?

Prodarsan is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug is still in clinical development, and its safety and effectiveness have not been established for the treatment of Cockayne Syndrome.