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

• Sponsor: Dr. Reddy's Laboratories Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02571049
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous DFN-11 in subjects with rapidly escalating migraine headaches.

Condition or Disease	Intervention/Treatment	Phase
Rapidly Escalating Migraine	Drug: DFN-11	Phase 2

Detailed Description

Pilot study to compare the proportion of subjects experiencing pain freedom at 60 minutes post-treatment between headache treated with Strength A of DFN-11 and Strength B of DFN-11

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment periodDFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind, Crossover, Comparator Pilot Study of DFN-11 Injection (Strength A vs. Strength B) for Rapidly Escalating Migraine
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sumatriptan 3 mg then 6 mg DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections	Drug: DFN-11; Sumatriptan 3 mg versus 6 mg; Other Names: Sumatriptan succinate injection
Experimental: Sumatriptan 6 mg then 3 mg Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo	Drug: DFN-11; Sumatriptan 3 mg versus 6 mg; Other Names: Sumatriptan succinate injection

Outcome Measures

Primary Outcome Measures

1. The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment [60 minutes post-treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis of episodic migraine, with or without aura for at least 1 year prior to screening

2. Experience an average of 2 to 8 migraines per month for the past 12 months of which approximately 75% or more rapidly escalate to moderate or severe pain within 2 hours of onset

3. Females must:

• be practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], or male partner sterilization) before entry and throughout the study, or

• be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or

• be postmenopausal (spontaneous amenorrhea for at least 1 year)

1. Females of child-bearing potential must have a negative urine pregnancy test at screening

2. Able and willing to read and comprehend written instructions and complete the electronic diary information required by the protocol

3. Must have internet access to complete daily headache diary

Exclusion Criteria:

1. Inability to distinguish migraine from other primary headaches

2. Experiences headache of any kind at a frequency greater than or equal to 15 days per month

3. Chronic opioid therapy (> 10 days in the 30 days prior to screening)

4. Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks before randomization

5. Hemiplegic or basilar migraine

6. History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes

7. Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg in 2 out of 3 readings)

8. History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure

9. History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria.

10. Systemic disease, which in the opinion of the Investigator, would contraindicate participation

11. History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation

12. Pregnant or lactating women

13. Have taken any investigational medication within 30 days before randomization, or are scheduled to receive an investigational drug

14. Subjects with a positive urine drug screen for recreational drugs or marijuana (whether legal or not) or for prescription drugs not explained by stated concomitant medications

15. Clinical laboratory or electrocardiogram (ECG) abnormality that in the opinion of the Investigator would endanger the subject or interfere with the study conduct. If the results of the clinical laboratory or ECG are outside of normal reference range the subject may still be enrolled but only if these findings are determined to be not clinically significant by the Investigator. This determination must be recorded in the subject's source document prior to enrolment.

16. Fridericia's corrected QT (QTcF) interval greater than 450 msec

17. Severe renal impairment (creatinine > 2 mg/dl)

18. Serum total bilirubin > 2.0 mg/dL

19. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal

20. Subjects who in the opinion of the investigator experience rebound headache from caffeine usage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinvest	Springfield	Missouri	United States	65807

Sponsors and Collaborators

• Dr. Reddy's Laboratories Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Reddy's Laboratories Limited
• ClinicalTrials.gov Identifier: NCT02571049
• Other Study ID Numbers: DFN-11-CD-006
• First Posted: Oct 8, 2015
• Last Update Posted: Feb 26, 2019
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Migraine Disorders; Sumatriptan

Study Results

Participant Flow

Arm/Group Title	Sumatriptan 3 mg Then 6 mg	Sumatriptan 6 mg Then 3 mg
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
Period Title: Screening
STARTED	8	12
COMPLETED	8	10
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All subjects who were randomized into the study
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.80 (10.40)
Sex: Female, Male (Count of Participants)
Female	16 80%
Male	4 20%

Outcome Measures

1. Primary Outcome

Title	The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment
Time Frame	60 minutes post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sumatriptan 3 mg	Sumatriptan 6 mg
Arm/Group Description	DFN-11 active injection and placebo injection	Two DFN-11 active injections
Measure Participants	18	19
Number [Percentage of responders]	50	52.63

Adverse Events

Arm/Group Title	Sumatriptan 3 mg SC		Sumatriptan 6 mg SC
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Sumatriptan 3 mg SC		Sumatriptan 6 mg SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Sumatriptan 3 mg SC		Sumatriptan 6 mg SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/20 (70%)		18/20 (90%)
Ear and labyrinth disorders
Tinnitus	0/20 (0%)	0	1/20 (5%)	1
Gastrointestinal disorders
Vomiting	0/20 (0%)	0	1/20 (5%)	1
General disorders
Flushing	2/20 (10%)	2	2/20 (10%)	2
Chest pain	0/20 (0%)	0	2/20 (10%)	2
Muscle Contraction	1/20 (5%)	1	2/20 (10%)	2
Myalgia	0/20 (0%)	0	1/20 (5%)	1
Malaise	1/20 (5%)	1	0/20 (0%)	0
Hyperhidrosis	1/20 (5%)	1	0/20 (0%)	0
Musculoskeletal and connective tissue disorders
Neck pain	4/20 (20%)	4	3/20 (15%)	3
Nervous system disorders
Paraesthesia	5/20 (25%)	5	4/20 (20%)	4
Dizziness	0/20 (0%)	0	1/20 (5%)	1
Disorientation	0/20 (0%)	0	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

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.