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NPS 1776

Phase 2

Migraine Headache | Small molecule | Neurology |Takeda Pharmaceutical Company Limited|Trials Updated: Jun 3, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment189

FDA Designations

No designations recorded

NPS 1776 clinical trials

NPS 1776 · 1 trial · 1 indication

Phase 2 1
NCT00172094Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine HeadachesMigraine Headache
COMPLETED189 Analytics
PHASE2COMPLETED
Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches
Migraine HeadacheUnlock trial analytics

Study Endpoints

Primary Endpoints

The response rate at 2 hours post-dose such that the percentage of subjects whose migraine pain-intensity score is none [0] or mild [1] at 2 hours post-dose, after a baseline pain intensity of moderate [2] or severe [3]
2 hours post-dose

Secondary Endpoints

Pain-free rate at 2 hours post-dose
2 hours post-dose
Response rate up to 48 (±24) hours post-dose
48 hours post-dose
Recurrence rate of migraine headache within 24 hours post dose
24 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATORPLACEBO
2EXPERIMENTAL400 mg 1776 powder
3EXPERIMENTAL1776 (800 mg)

Interventions

NameTypeDescription
NPS 1776 (800 mg)DRUGNPS 1776 (800 mg) powder
PLACEBODRUGPlacebo in non-carbonated fruit flavored drink (150 ml)
NPS 1776 (400 mg)DRUGNPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: 1. Diagnosis of migraine for at least a year prior to screening. 2. Experiences 2-10 migraine headaches per month (with at least 24 hours between episodes) and no more than 15 headache days per month in the 3 months prior to screening. 3. Ability and willingness to arrive at the...

Countries:United States
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Frequently asked questions about NPS 1776

What is NPS 1776 used for?

NPS 1776 is an investigational small molecule developed for the acute treatment of migraine headaches. It was studied in a Phase 2 clinical trial in adults with migraine. NPS 1776 has not been approved for any indication and remains in clinical development.

Who is developing NPS 1776?

NPS 1776 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 2 clinical trial of NPS 1776 in migraine headaches.

What phase is NPS 1776 in?

NPS 1776 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is NPS 1776 in?

NPS 1776 has been studied in one completed Phase 2 trial, NCT00172094, titled Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches. The randomized, double-blind, placebo-controlled trial enrolled 189 participants in the United States.