Episodic Cluster HeadachePhase 2NCT02209155
R-Verapamil for the Prophylaxis of Episodic Cluster Headache
A Phase 2 study testing R-verapamil 75 mg tablet in people with Episodic Cluster Headache, run by Center Laboratories, Inc. at 1 site in United Kingdom.
Trial summary
This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Episodic Cluster Headache
- What is being tested?
- R-verapamil 75 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy man or woman between the ages of 18 and 65
- In good health as determined by medical history and medical examination
- Has a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition)
- Has a lifetime prevalence of at least 2 prior cluster bouts - Subjects must experience at least 7 attacks/week during the run-in baseline period
- Subjects must have a typical cluster period lasting at least 1 month. Subjects must be present in active cluster period and the expected remaining duration of the cluster cycle must be at least 3 weeks from Baseline Day 1 visit
- Able to differentiate other headache types from cluster headaches
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- Is using or agrees to use a medically acceptable form of contraception(female of child-bearing potential)
- Negative urine pregnancy test prior to study entry(female of child-bearing potential)
- Concomitant medication that, in the opinion of the investigator and the patient's general practitioner(GP), do not pose an unacceptable risk based upon the prescribing information for verapamil
- Able to understand and comply with all study requirements
- Written informed consent
Who cannot join
- Women who are pregnant or lactating
- Subjects who, in the investigators opinion, have a history 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
- Use of any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication
- The concomitant use of beta blockers
- The consumption of grapefruit juice
- Allergic to or has shown hypersensitivity to verapamil or agents similar to verapamil
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- Abuses opioids or has a history of significant drug or alcohol abuse within the past year as determined by investigator
- Has participated in an investigational drug trial in the 30 days prior to the screening visit
- Has liver or kidney disease
- Has a cardiopathology contraindicating verapamil administration
- Subjects with previous adynamic ileus.
- Subjects with chronic cluster headache
- Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
UCLH/UCL NIHR Clinical Research Facility
London, NW1 2BU
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of R-Verapamil in the Prophylaxis of Episodic Cluster Headache
This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.
Read the detailed description
Approximately 30 subjects (about 15 per treatment group),will be enrolled and randomized to receive either R-verapamil or placebo for 2 weeks. The study will consist of a 1-week run-in period and a 2-week treatment period (R-verapamil or placebo). The total duration of the study for each treatment group is 3 weeks.
- Conditions
- Episodic Cluster Headache
- Being tested
- R-verapamil 75 mg tablet, Placebo
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-verapamil 75 mg tabletDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| R-verapamil 75 mg tablet | Active comparator | 375 mg/day; one in the morning, two in the afternoon and two at bedtime daily Receives: Drug: R-verapamil 75 mg tablet |
| Placebo | Placebo comparator | one in the morning, two in the afternoon and two at bedtime daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the average daily frequency of attacks
Measured: 2 weeks
Secondary outcomes (8)
Change in the average daily frequency of attacks
Measured: 1 week
Change in intensity of attacks
Measured: 2 weeks
Change in duration of attacks
Measured: 2 weeks
Change in consumption of abortive agents
Measured: 2 weeks
Patient acceptability of treatment
Measured: 2 weeks
Change in headache severity index
Measured: 2 weeks
Change in Hit-6 disability score
Measured: 2 weeks
R-verapamil and Placebo responders
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209155
- Sponsor's protocol ID
- R-Verapamil-001
- Status last verified
- Apr 2018
- First submitted
- 4 Aug 2014
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of R-Verapamil in the Prophylaxis of Episodic Cluster Headache
- ClinicalTrials.gov ID
- NCT02209155
- Acronym / sponsor ID
- R-Verapamil-001
- Conditions
- Episodic Cluster Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Center Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.
Detailed description
Approximately 30 subjects (about 15 per treatment group),will be enrolled and randomized to receive either R-verapamil or placebo for 2 weeks. The study will consist of a 1-week run-in period and a 2-week treatment period (R-verapamil or placebo). The total duration of the study for each treatment group is 3 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-verapamil 75 mg tablet | Active comparator | Drug: R-verapamil 75 mg tablet375 mg/day; one in the morning, two in the afternoon and two at bedtime daily |
| Placebo | Placebo comparator | Drug: Placeboone in the morning, two in the afternoon and two at bedtime daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy man or woman between the ages of 18 and 65
- In good health as determined by medical history and medical examination
- Has a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition)
- Has a lifetime prevalence of at least 2 prior cluster bouts - Subjects must experience at least 7 attacks/week during the run-in baseline period
- Subjects must have a typical cluster period lasting at least 1 month. Subjects must be present in active cluster period and the expected remaining duration of the cluster cycle must be at least 3 weeks from Baseline Day 1 visit
Key exclusion criteria (13 listed)
- Women who are pregnant or lactating
- Subjects who, in the investigators opinion, have a history 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
- Use of any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication
- The concomitant use of beta blockers
- The consumption of grapefruit juice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-verapamil 75 mg tablet | Drug | R-verapamil 75 mg tablet |
| Placebo | Drug | Placebo |
Primary outcome
Change in the average daily frequency of attacks
Time frame: 2 weeks
8 secondary outcomes
Change in the average daily frequency of attacks
Time frame: 1 week
Change in intensity of attacks
Time frame: 2 weeks
Change in duration of attacks
Time frame: 2 weeks
Change in consumption of abortive agents
Time frame: 2 weeks
Patient acceptability of treatment
Time frame: 2 weeks
Change in headache severity index
Time frame: 2 weeks
Change in Hit-6 disability score
Time frame: 2 weeks
R-verapamil and Placebo responders
Time frame: 2 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-verapamil 75 mg tablet in people with Episodic Cluster Headache, run by Center Laboratories, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the average daily frequency of attacks (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.