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Pilot Study of DFN-11 Injection in Medication Overuse Headache

Primary Purpose

Medication Overuse Headache

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DFN-11 Injection
Sponsored by
Dr. Reddy's Laboratories Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medication Overuse Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of medication overuse headache within the past year in the following categories
  2. Diagnosis of migraine, with or without aura for at least 12 months
  3. Experience an average of > 10 headache days per month for the past 12 months
  4. Females must:

    i. 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 willing to continue throughout the study, or ii. be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or iii. be postmenopausal (spontaneous amenorrhea for at least 1 year)

  5. Females of child-bearing potential must have a negative urine pregnancy test at all visits.
  6. Able and willing to read and comprehend written instructions and complete the electronic diary.
  7. Must have internet access to complete daily headache diary.

Exclusion Criteria:

  1. Current use of medication for headache/migraine prophylaxis that has not been stable for 30 days prior to screening. Stable is defined as no recent dosing change within 30 days of screening.
  2. Hemiplegic or basilar migraine
  3. History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
  4. Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg in 2 out of 3 readings)
  5. Clinically significant hepatic impairment
  6. History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure
  7. History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria
  8. Systemic disease, which in the opinion of the Investigator, would contraindicate participation
  9. History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation
  10. Pregnant or lactating women
  11. Have taken any investigational medication within 30 days before screening, or are scheduled to receive an investigational drug
  12. 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
  13. 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.
  14. Fridericia's corrected QT (QTcF) interval greater than 450 msec
  15. Severe renal impairment (creatinine > 2 mg/dl)
  16. Serum total bilirubin > 2.0 mg/dL
  17. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal
  18. Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) > 7.0%, or with diabetes mellitus requiring insulin
  19. Subjects who in the opinion of the investigator experience rebound headache from caffeine usage

Sites / Locations

  • Clinvest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DFN-11

Arm Description

DFN-11 Injection upon occurrence of migraine

Outcomes

Primary Outcome Measures

The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)

Secondary Outcome Measures

The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)

Full Information

First Posted
October 1, 2015
Last Updated
March 7, 2018
Sponsor
Dr. Reddy's Laboratories Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02583425
Brief Title
Pilot Study of DFN-11 Injection in Medication Overuse Headache
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Overuse Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DFN-11
Arm Type
Experimental
Arm Description
DFN-11 Injection upon occurrence of migraine
Intervention Type
Drug
Intervention Name(s)
DFN-11 Injection
Primary Outcome Measure Information:
Title
The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)
Time Frame
28 days Baseline period and 28 days of Treatment period (Total 56 days)
Secondary Outcome Measure Information:
Title
The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)
Time Frame
28 days Baseline period and 28 days of Treatment period (Total 56 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of medication overuse headache within the past year in the following categories Diagnosis of migraine, with or without aura for at least 12 months Experience an average of > 10 headache days per month for the past 12 months Females must: i. 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 willing to continue throughout the study, or ii. be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or iii. be postmenopausal (spontaneous amenorrhea for at least 1 year) Females of child-bearing potential must have a negative urine pregnancy test at all visits. Able and willing to read and comprehend written instructions and complete the electronic diary. Must have internet access to complete daily headache diary. Exclusion Criteria: Current use of medication for headache/migraine prophylaxis that has not been stable for 30 days prior to screening. Stable is defined as no recent dosing change within 30 days of screening. Hemiplegic or basilar migraine History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg in 2 out of 3 readings) Clinically significant hepatic impairment History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria Systemic disease, which in the opinion of the Investigator, would contraindicate participation History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation Pregnant or lactating women Have taken any investigational medication within 30 days before screening, or are scheduled to receive an investigational drug 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 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. Fridericia's corrected QT (QTcF) interval greater than 450 msec Severe renal impairment (creatinine > 2 mg/dl) Serum total bilirubin > 2.0 mg/dL Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) > 7.0%, or with diabetes mellitus requiring insulin Subjects who in the opinion of the investigator experience rebound headache from caffeine usage
Facility Information:
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States

12. IPD Sharing Statement

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Pilot Study of DFN-11 Injection in Medication Overuse Headache

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