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DFN-11 Injection in Episodic Migraine With or Without Aura (RESTOR)

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ClinicalTrials.gov Identifier: NCT02569853
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Episodic Migraine
Interventions Drug: DFN-11
Other: Placebo
Enrollment 268
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DFN-11 - Double-Blind Placebo - Double-Blind
Hide Arm/Group Description

DFN-11 active injection upon occurrence of migraine

DFN-11

Placebo injection upon occurrence of migraine

Placebo

Period Title: Overall Study
Started 131 137
Completed 111 123
Not Completed 20 14
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             3             2
Lost to Follow-up             3             3
Protocol Violation             1             1
Did not experience migraine attack             10             7
Physician Decision             1             1
Arm/Group Title DFN-11 - Double-blind Placebo - Double-blind Total
Hide Arm/Group Description

DFN-11 active injection upon occurrence of migraine

DFN-11

Placebo injection upon occurrence of migraine

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 131 137 268
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 137 participants 268 participants
41.9  (12.47) 40.2  (12.28) 41.0  (12.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 137 participants 268 participants
Female
20
  15.3%
19
  13.9%
39
  14.6%
Male
111
  84.7%
118
  86.1%
229
  85.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 137 participants 268 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.8%
3
   2.2%
4
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.5%
2
   0.7%
Black or African American
29
  22.1%
23
  16.8%
52
  19.4%
White
98
  74.8%
105
  76.6%
203
  75.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.3%
4
   2.9%
7
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 131 participants 137 participants 268 participants
131 137 268
1.Primary Outcome
Title The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary
Hide Description [Not Specified]
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects analyzed had efficacy data at the time of specified assessment
Arm/Group Title DFN-11 - Double-Blind Placebo - Double-Blind
Hide Arm/Group Description:

DFN-11 active injection upon occurrence of migraine

DFN-11

Placebo injection upon occurrence of migraine

Placebo

Overall Number of Participants Analyzed 104 104
Measure Type: Number
Unit of Measure: Percentage of responders
51.0 30.8
2.Secondary Outcome
Title The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 1 Hour After Dosing as Reported by the Subject in the eDiary
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects analyzed had efficacy data at the time of specified assessment
Arm/Group Title DFN-11 Placebo
Hide Arm/Group Description:

DFN-11 active injection upon occurrence of migraine

DFN-11

Placebo injection upon occurrence of migraine

Placebo

Overall Number of Participants Analyzed 104 101
Measure Type: Number
Unit of Measure: Percentage of responders
34.6 19.8
Time Frame During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DFN-11 - Double-blind Placebo - Double-blind
Hide Arm/Group Description

DFN-11 active injection upon occurrence of migraine

DFN-11

Placebo injection upon occurrence of migraine

Placebo

All-Cause Mortality
DFN-11 - Double-blind Placebo - Double-blind
Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)      0/137 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DFN-11 - Double-blind Placebo - Double-blind
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/131 (0.00%)      0/137 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DFN-11 - Double-blind Placebo - Double-blind
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/131 (28.24%)      16/137 (11.68%)    
Cardiac disorders     
Sinus tachycardia   1/131 (0.76%)  1 0/137 (0.00%)  0
Ventricular extrasystoles   1/131 (0.76%)  1 0/137 (0.00%)  0
Gastrointestinal disorders     
Nausea   2/131 (1.53%)  2 0/137 (0.00%)  0
diarrhea   1/131 (0.76%)  1 0/137 (0.00%)  0
Dysphagia   1/131 (0.76%)  1 0/137 (0.00%)  0
General disorders     
Injection site reaction   24/131 (18.32%)  29 14/137 (10.22%)  18
Paraesthesia   3/131 (2.29%)  3 0/137 (0.00%)  0
Chest discomfort   1/131 (0.76%)  1 2/137 (1.46%)  2
Infections and infestations     
Ear infection   1/131 (0.76%)  1 0/137 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Throat tightness   2/131 (1.53%)  2 0/137 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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, Clinical Development
Organization: Dr. Reddy's
Phone: 609-375-9900
Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02569853     History of Changes
Other Study ID Numbers: DFN-11-CD-004
First Submitted: October 1, 2015
First Posted: October 7, 2015
Results First Submitted: June 27, 2018
Results First Posted: July 25, 2018
Last Update Posted: July 25, 2018