Episodic Cluster Headache MedDRA version: 15.0 Level: PT Classification code 10059133 Term: Cluster headache System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: RV Tablet
Product Code: R-verapamil?HCl
Pharmaceutical Form: Tablet
INN or Proposed INN: R-Verapamil Hydrochloride
CAS Number: 38176-02-2
Current Sponsor code: R-verapamil?HCl
Other de
Sponsors
CENTER LABORATORIES, INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participants will be healthy men and women between the ages of 18 and 65 • Participants in good health as determined by medical history and medical examination including vital signs and ECG. Serum biochemistry and hematology need to be normal • Participants with a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition) • Participants must have a lifetime prevalence of at least 2 prior cluster bouts • Participants must experience at least 7 attacks/week during the run-in baseline period • Participants must have a typical cluster period lasting at least 1 month. Subjects must present in active cluster period and the expected remaining duration of the cluster bout must be at least 3 weeks from Baseline Day 1 visit • Participants with other headache types are eligible provided the subject is able to differentiate these headaches from cluster headaches • Participants are using or agree to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential • Participants have a negative urine pregnancy test prior to study entry, if female of child-bearing potential • Participants is able to understand and comply with all study requirements • Participants provides written informed consent prior to any screening procedures being conducted Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Women who are pregnant or lactating • Participants who, in the investigators opinion, have a history of or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial • Participants using any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication • Participants who are allergic to or have shown hypersensitivity to verapamil or agents similar to verapamil • Participants who abuse opioids or have a history of significant drug or alcohol abuse within the past year as determined by investigator • Participants who have participated in an investigational drug trial in the 30 days prior to the screening visit • Participants with liver or kidney disease • Participants with cardiopathology contraindicating verapamil administration (second or third grade atrioventricular block, sinoatrial block, sinus node syndrome, heart rate <50/minute, or systolic blood pressure <90 mm Hg) • Participants with previous adynamic ileus • Participants with chronic cluster headache • Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the safety of R-verapamil. The safety assessments include: - adverse events - clinical laboratory measurements (chemistry and hematology) - vital signs - physical examinations - ECGs (will be obtained on Day 8 prior to the single 75 mg dose of R-verapamil and at 1 hour post dose and at the end of study visit) ;Secondary Objective: The secondary objective is to evaluate the effectiveness of R-verapamil in the prevention of episodic cluster headaches ;Primary end point(s): Change in the average daily frequency of attacks. ;Timepoint(s) of evaluation of this end point: Change in the average daily frequency of attacks between the baseline run-in period and the end of the 2 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in the average daily frequency of attacks - Change in intensity of attacks - Change in duration of attacks - Change in consumption of abortive agents - Patient acceptability of treatment on a 0-10 scale - Change in headache severity index - Change in Hit-6 disability score - R-verapamil-responders - Placebo-responders ;Timepoint(s) of evaluation of this end point: - Change in intensity of attacks, duration of attacks, headache severity index, Hit-6 disability score and in consumption of abortive agents by diary between the baseline run-in period and the end of the 1 and 2 week treatment periods - Patient acceptability of treatment on a 0-10 scale at the end of the 2 week treatment period. - R-verapamil-responders at the end of the 1 and 2 week treatment periods - Placebo-responders at the end of the 1 and 2 week treatment periods | — |
Countries
United Kingdom
Contacts
Public ContactElaine Harrison
European Medical Advisory Services Ltd
Outcome results
None listed