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SER120 500 ng/day

Phase 3

Nocturia | Small molecule | Other |Avadel Pharmaceuticals plc|Last Updated: Nov 17, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

SER120 500 ng/day · 1 trial · 1 indication

Phase 3 1
NCT01259128Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With NocturiaNocturia
COMPLETED32 Analytics
PHASE3COMPLETED
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Nocturia
NCT0125912832
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Study Endpoints

Primary Endpoints

Serum Sodium Levels at Baseline and During Treatment
baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57

Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.

Secondary Endpoints

Change in Mean Nocturic Episodes Per Night
Mean value at Week 8 minus mean value at baseline
Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SER120 500 ng/dayEXPERIMENTALSER120 Level 1 (500 ng/day)
SER120 750 ng/dayEXPERIMENTALSER120 Level 2 (750 ng/day)

Interventions

NameTypeDescription
SER120 Nasal Spray 500 ng/dayDRUGSER120 Level 1
SER120 nasal spray 750 ng/dayDRUGSER120 (750 ng/day)
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Eligibility Criteria

Age Range75 Years to 95 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male \& female greater or equal to 75 years of age, history of nocturia Exclusion Criteria: * CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome * U...

Countries:United States
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Frequently asked questions about SER120 500 ng/day

What is SER120 500 ng/day used for?

SER120 500 ng/day is an investigational small molecule being developed for the treatment of nocturia, a condition characterized by the need to urinate frequently during the night. It is administered as a nasal spray and is currently in Phase 3 clinical development.

Who makes SER120 500 ng/day?

SER120 500 ng/day is being developed by Avadel Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVDL. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational nasal spray for nocturia.

What phase is SER120 500 ng/day in?

SER120 500 ng/day is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under evaluation for the treatment of nocturia.

What clinical trials is SER120 500 ng/day in?

SER120 500 ng/day has been studied in one completed Phase 3 clinical trial, identified as NCT01259128. This trial, titled 'Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia,' enrolled 32 participants in the United States and included patients aged 75 years and older.

Is SER120 500 ng/day the same as SER120?

SER120 500 ng/day is a specific dosage form of the investigational drug SER120, which is being developed by Avadel Pharmaceuticals. The '500 ng/day' designation refers to the daily dose of the nasal spray formulation being studied for nocturia.