A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
ClinicalTrials.gov processed this data on November 21, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - HAS RESULTS(See Contacts and Locations)
Verified November 2023 by Satsuma Pharmaceuticals, Inc.
Sponsor
Satsuma Pharmaceuticals, Inc.Information Provided by (Responsible Party)
Satsuma Pharmaceuticals, Inc.Clinicaltrials.gov Identifier
NCT04940390Other Study ID Numbers: STS101-007
First Submitted: June 17, 2021
First Posted: June 25, 2021
Results First Posted: July 24, 2023
Last Update Posted: November 27, 2023
Last Verified: November 2023
History of Changes
Disclaimer
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
Study Description
Study STS101-007 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).| Condition or Disease | Intervention/Treatment |
|---|---|
|
|
Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 1591 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Triple |
| Primary Purpose | Treatment |
| Official Title | A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine |
| Study Start Date | June 30, 2021 |
| Actual Primary Completion Date | October 13, 2022 |
| Actual Study Completion Date | October 26, 2022 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
|---|---|
|
|
|
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose [2 Hours Post-Dose] The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
- Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose [2 Hours Post-Dose] Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.
Secondary Outcome Measures
- Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose [2 Hours Post Dose] The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain relief means the pain went from moderate (2) or severe (3) to mild pain (1) or no pain (0).
Eligibility Criteria
| Ages Eligible for Study | 18 Years to 65 Years (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
|
| Exclusion Criteria |
|
Contacts and Locations
| Sponsors and Collaborators | Satsuma Pharmaceuticals, Inc. |
|---|---|
| Locations |
|
| Investigators |
Study Documents (Full Text)
- Documents Provided by Satsuma Pharmaceuticals, Inc.: Study Protocol May 20, 2021
- Documents Provided by Satsuma Pharmaceuticals, Inc.: Statistical Analysis Plan October 17, 2022
More Information
Additional Relevant MeSH Terms
- Migraine Disorders
- Migraine without Aura
- Migraine with Aura
- Headache Disorders, Primary
- Headache Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases