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NPS 1776

Phase 2

Migraine Headache | Small molecule | Neurology |Takeda Pharmaceutical Company Limited|Last 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

Clinical trial landscape

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 being studied for the acute treatment of migraine headaches. It is a Phase 2 drug candidate in the neurology therapeutic area. As of the available data, it is not approved and remains in clinical development.

Who makes NPS 1776?

NPS 1776 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is a small molecule in Phase 2 clinical development for the acute treatment of migraine headaches.

What phase is NPS 1776 in?

NPS 1776 is in Phase 2 clinical development. It is an investigational drug for the acute treatment of migraine headaches and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is NPS 1776 in?

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

Is NPS 1776 FDA approved?

NPS 1776 is not FDA approved. It is an investigational drug in Phase 2 clinical development for the acute treatment of migraine headaches. The available data shows one completed Phase 2 trial, but no approval status has been established.