Migraine Disorders
Conditions
Keywords
Migraine, Sumatriptan Succinate Injection Kit, Cluster Headache, self-injection
Brief summary
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.
Interventions
Sumatriptan Succinate
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II) * History of migraine or cluster headache persisting for at least 6 months * Migraine: One to 6 attacks of moderate or severer headaches per month during the 2 months prior to enrollment * Cluster Headache: Each attack persisting for at least 45 minutes * Written informed consent obtained from the patient. When a patient is a minor, written informed consent from his/her proxy consenter (e.g., person with parental authority) will also be required.
Exclusion criteria
* History of hypersensitivity to any of the ingredients of 5-HT1B/1D receptor antagonists (e.g., triptans) or serious AE due to treatment with these drugs * History of serious adverse event attributable to treatment with Imigran® Injection 3 * History of myocardial infarction, current or previous history of ischemic heart disease or its symptoms/signs, or current history of atypical variant angina (coronary arteriospasm) * Previous history of cerebrovascular disorder or transient cerebral ischemic attack * Current or previous history of peripheral angiopathy (including Raynaud's syndrome) * Systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>95 mmHg at the start of treatment period * Current familial hemiplegic migraine, basilar migraine, or sporadic hemiplegic migraine * Current abuse of ergotamine- or dihydroergotamine-containing preparations or triptans * Pregnant women, lactating mothers, women who may be pregnant, or women of childbearing potential using no appropriate contraceptive measures. * Epilepsy or organic cerebral disorder which may lead to convulsion * Previous history of hypersensitivity to sulfonamides * Known drug allergy or idiosyncrasies * Known drug dependency or alcoholism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | 30 minutes or 60 Minutes after each administration | Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Up to 2 months | The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was Was the kit product easy to use?, question 2 was Do you want to use the kit product in the future? and question 3 was Do you consider that the kit product is necessary for the treatment of your illness?. The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented. |
| Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate | Up to 2 months | The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented. |
Countries
Japan
Participant flow
Recruitment details
This study was conducted from 20 June 2006 to 07 August 2006 across four centers in Japan.
Pre-assignment details
A total of 75 participants with history of migraine or cluster headache persisting for at least 6 months had entered into the study.
Participants by arm
| Arm | Count |
|---|---|
| Migraine Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh. | 33 |
| Cluster Headache Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh. | 33 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 6 | 3 |
Baseline characteristics
| Characteristic | Migraine | Cluster Headache | Total |
|---|---|---|---|
| Age, Continuous | 41.2 Years STANDARD_DEVIATION 9.9 | 37.4 Years STANDARD_DEVIATION 9 | 39.3 Years STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 33 Participants | 33 Participants | 66 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 26 Participants | 8 Participants | 34 Participants |
| Sex: Female, Male Male | 7 Participants | 25 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 | 0 / 66 |
| other Total, other adverse events | 5 / 33 | 10 / 33 | 15 / 66 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 0 / 66 |
Outcome results
Primary
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
Time frame: 30 minutes or 60 Minutes after each administration
Population: Full Analysis Set (FAS) Population included patients who self-administered the study product and have at least one efficacy data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine | Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | 93.9 Percentage of participants |
| Cluster Headache | Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | 93.9 Percentage of participants |
| Migraine + Cluster Headache | Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | 93.9 Percentage of participants |
Secondary
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was Was the kit product easy to use?, question 2 was Do you want to use the kit product in the future? and question 3 was Do you consider that the kit product is necessary for the treatment of your illness?. The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented.
Time frame: Up to 2 months
Population: FAS Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Migraine | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 1: Yes | 32 Participants |
| Migraine | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 2: Yes | 31 Participants |
| Migraine | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 3: Yes | 31 Participants |
| Migraine | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 1: No | 1 Participants |
| Migraine | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 2: No | 2 Participants |
| Migraine | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 3: No | 2 Participants |
| Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 2: Yes | 31 Participants |
| Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 1: Yes | 33 Participants |
| Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 1: No | 0 Participants |
| Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 3: No | 4 Participants |
| Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 3: Yes | 29 Participants |
| Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 2: No | 2 Participants |
| Migraine + Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 1: Yes | 65 Participants |
| Migraine + Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 3: Yes | 60 Participants |
| Migraine + Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 3: No | 6 Participants |
| Migraine + Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 2: No | 4 Participants |
| Migraine + Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 1: No | 1 Participants |
| Migraine + Cluster Headache | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Question 2: Yes | 62 Participants |
Secondary
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented.
Time frame: Up to 2 months
Population: FAS Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine | Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate | 100 Percentage of participants |
| Cluster Headache | Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate | 100 Percentage of participants |
| Migraine + Cluster Headache | Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate | 100 Percentage of participants |