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Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine

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ClinicalTrials.gov Identifier: NCT02571049
Recruitment Status : Completed
First Posted : October 8, 2015
Results First Posted : July 24, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rapidly Escalating Migraine
Intervention Drug: DFN-11
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sumatriptan 3 mg Then 6 mg Sumatriptan 6 mg Then 3 mg
Hide Arm/Group Description Subjects were first dispensed one sumatriptan 3 mg autoinjector and one matching placebo autoinjector to self-administer consecutively in one migraine attack (total 3 mg active sumatriptan) and in the next study visit were dispensed two sumatriptan 3 mg autoinjectors to self-administer consecutively in another migraine attack (total 6 mg active sumatriptan). Subjects were first dispensed two sumatriptan 3 mg autoinjectors to self-administer consecutively in one migraine attack (total 6 mg active sumatriptan) and in the next study visit were dispensed one sumatriptan 3 mg autoinjector and one matching placebo autoinjector to self-administer consecutively in one migraine attack (total 3 mg active sumatriptan) .
Period Title: Screening
Started 10 14
Completed 8 12
Not Completed 2 2
Reason Not Completed
Did not meet entry criteria             2             2
Period Title: Randomization
Started 8 12
Completed 8 10
Not Completed 0 2
Reason Not Completed
No migraine attack             0             1
Adverse Event             0             1
Arm/Group Title All Subjects
Hide Arm/Group Description All subjects who were randomized into the study
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
39.80  (10.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
16
  80.0%
Male
4
  20.0%
1.Primary Outcome
Title The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment
Hide Description [Not Specified]
Time Frame 60 minutes post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan 3 mg Sumatriptan 6 mg
Hide Arm/Group Description:
DFN-11 active injection and placebo injection
Two DFN-11 active injections
Overall Number of Participants Analyzed 18 19
Measure Type: Number
Unit of Measure: Percentage of responders
50 52.63
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sumatriptan 3 mg SC Sumatriptan 6 mg SC
Hide Arm/Group Description All subjects who had an AE when treated with sumatriptan 3 mg SC All subjects who had an AE when treated with sumatriptan 6 mg SC
All-Cause Mortality
Sumatriptan 3 mg SC Sumatriptan 6 mg SC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sumatriptan 3 mg SC Sumatriptan 6 mg SC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sumatriptan 3 mg SC Sumatriptan 6 mg SC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/20 (70.00%)      18/20 (90.00%)    
Ear and labyrinth disorders     
Tinnitus   0/20 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorders     
Vomiting   0/20 (0.00%)  0 1/20 (5.00%)  1
General disorders     
Flushing   2/20 (10.00%)  2 2/20 (10.00%)  2
Chest pain   0/20 (0.00%)  0 2/20 (10.00%)  2
Muscle Contraction   1/20 (5.00%)  1 2/20 (10.00%)  2
Myalgia   0/20 (0.00%)  0 1/20 (5.00%)  1
Malaise   1/20 (5.00%)  1 0/20 (0.00%)  0
Hyperhidrosis   1/20 (5.00%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Neck pain   4/20 (20.00%)  4 3/20 (15.00%)  3
Nervous system disorders     
Paraesthesia   5/20 (25.00%)  5 4/20 (20.00%)  4
Dizziness   0/20 (0.00%)  0 1/20 (5.00%)  1
Disorientation   0/20 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Development
Organization: Dr. Reddy's
Phone: 609-375-9900
Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02571049     History of Changes
Other Study ID Numbers: DFN-11-CD-006
First Submitted: October 1, 2015
First Posted: October 8, 2015
Results First Submitted: February 15, 2018
Results First Posted: July 24, 2018
Last Update Posted: February 26, 2019