Cluster HeadachePhase 2/3CHCINCT00804895
Cluster Headache Cortivazol Injection (CHCI)
A Phase 2/3 study testing ALTIM, cortivazol injections, PROAMP, subcutaneous serum physiological saline and Verapamil in people with Cluster Headache, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache
- What is being tested?
- ALTIM, cortivazol injections, PROAMP, subcutaneous serum physiological saline and Verapamil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Oct 2009
- Phase
- Phase 2/3
- 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
- patient age, man or woman whose age is between 18 and 65 included
- patient who signed a free express and informed consent
- patient with cluster headache, episodic or chronic according to the criteria of International Headache Society (ICHD-II)
- patient with more than two episodes of CH per day
- patient with a normal medical examination
Who cannot join
- patient not affiliated with a social security scheme (or beneficiary entitled)
- patient with another diagnosis ICHD-II,and being unable to differentiate CH attacks from its other cranial pain
- patient of CH having started his episodic active period more than 30 days ago
- patient with a contra-indication to verapamil
- patient with a known allergy to cortivazol
- patient with anticoagulant therapy or having a bleeding disorder
Show all 9Show fewer
- patient unable to complete the schedule crisis
- patient non-compliant or unable to follow the research protocol
- women without contraception, pregnant, or nursing
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)
Paris, Île-de-France Region, 75010
About this study
Official title: A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache
the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil.
Read the detailed description
Cluster headache is characterized by unilateral attacks of severe periorbital pain accompanied by autonomic symptoms and restlessness. Though patients may respond to the standard prophylactic treatment of verapamil, some are refractory and continue to suffer from numerous attacks, with a limit of two doses of subcutaneous sumatriptan per day. Some patients also have contra-indications to standard prophylactic or acute treatments. Other preventive treatments like systemic steroids, lithium and methysergide may cause significant side effects. We intend to show the efficacy of occipital nerve injections with cortivazol, in adjunct to verapamil, in cluster headache patients. We expect a diminution of attack frequency over two weeks, with a protocol of three injections separated by two or three days each. Tolerance and safety will be examined.
- Conditions
- Cluster Headache
- Being tested
- ALTIM, cortivazol injections, PROAMP, subcutaneous serum physiological saline, Verapamil
- Keywords
- cluster headache, greater occipital nerve block, cortivazol
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTIM, cortivazol injectionsDrug
Also called ALTIM, cortivazol injections greater occipital
ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
PROAMP, subcutaneous serum physiological salineDrug
Three injections will be performed at the level of the greater occipital nerve with a suboccipital approach. Injection will be separated by two or three days each.
VerapamilDrug
standard prophylactic treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | subcutaneous injection of Cortivazol ALTIM, 3,375mg Receives: Drug: ALTIM, cortivazol injections; Drug: Verapamil |
| 2 | Placebo comparator | PROAMP, subcutaneous serum physiological saline Receives: Drug: PROAMP, subcutaneous serum physiological saline; Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a daily attack frequency equal or inferior to two for the period going from two days after third injection to four days after the third injection
Measured: 2009
Secondary outcomes (10)
total number of attacks on the J1-J15 period
Measured: 2009
percentage of patients with a 50% or more decrease in attacks frequency at J15
Measured: 2009
percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more
Measured: 2009
interval between the first injection and appearance of a remission
Measured: 2009
percentage of patients suffering from chronic CH, having reached a daily attack frequency equal or inferior to two, presenting a recurrence of attacks after J15, defined as more than two attacks per day
Measured: 2009
number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30
Measured: 2009
number of chronic patients presenting a daily attack frequency equal or inferior to two at J90
Measured: 2009
HIT-6 scores, comparison between groups at J0 and J30
Measured: 2009
tolerance of treatment : percentage of patients showing side effects
Measured: 2009
safety of treatment: percentage of patients with serious adverse events
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique VALADE, MD, Principal investigator, CHU Lariboisière, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804895
- Sponsor's protocol ID
- P080602
- Acronym
- CHCI
- Status last verified
- Nov 2012
- First submitted
- 8 Dec 2008
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Leroux E, Valade D, Taifas I, Vicaut E, Chagnon M, Roos C, Ducros A. Suboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Oct;10(10):891-7. doi: 10.1016/S1474-4422(11)70186-7. Epub 2011 Sep 6.
PubMed 21903477
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache
- ClinicalTrials.gov ID
- NCT00804895
- Acronym / sponsor ID
- CHCI / P080602
- Conditions
- Cluster Headache
- Keywords
- cluster headache, greater occipital nerve block, cortivazol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Dec 2008 (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.
the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil.
Detailed description
Cluster headache is characterized by unilateral attacks of severe periorbital pain accompanied by autonomic symptoms and restlessness. Though patients may respond to the standard prophylactic treatment of verapamil, some are refractory and continue to suffer from numerous attacks, with a limit of two doses of subcutaneous sumatriptan per day. Some patients also have contra-indications to standard prophylactic or acute treatments. Other preventive treatments like systemic steroids, lithium and methysergide may cause significant side effects. We intend to show the efficacy of occipital nerve injections with cortivazol, in adjunct to verapamil, in cluster headache patients. We expect a diminution of attack frequency over two weeks, with a protocol of three injections separated by two or three days each. Tolerance and safety will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ALTIM, cortivazol injections, Drug: Verapamilsubcutaneous injection of Cortivazol ALTIM, 3,375mg |
| 2 | Placebo comparator | Drug: PROAMP, subcutaneous serum physiological saline, Drug: VerapamilPROAMP, subcutaneous serum physiological saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient age, man or woman whose age is between 18 and 65 included
- patient who signed a free express and informed consent
- patient with cluster headache, episodic or chronic according to the criteria of International Headache Society (ICHD-II)
- patient with more than two episodes of CH per day
- patient with a normal medical examination
Key exclusion criteria (9 listed)
- patient not affiliated with a social security scheme (or beneficiary entitled)
- patient with another diagnosis ICHD-II,and being unable to differentiate CH attacks from its other cranial pain
- patient of CH having started his episodic active period more than 30 days ago
- patient with a contra-indication to verapamil
- patient with a known allergy to cortivazol
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 |
|---|---|---|
| ALTIM, cortivazol injectionsAlso: ALTIM, cortivazol injections greater occipitalALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each. | Drug | 1 |
| PROAMP, subcutaneous serum physiological salineThree injections will be performed at the level of the greater occipital nerve with a suboccipital approach. Injection will be separated by two or three days each. | Drug | 2 |
| Verapamilstandard prophylactic treatment | Drug | 1, 2 |
Primary outcome
Number of patients with a daily attack frequency equal or inferior to two for the period going from two days after third injection to four days after the third injection
Time frame: 2009
10 secondary outcomes
total number of attacks on the J1-J15 period
Time frame: 2009
percentage of patients with a 50% or more decrease in attacks frequency at J15
Time frame: 2009
percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more
Time frame: 2009
interval between the first injection and appearance of a remission
Time frame: 2009
percentage of patients suffering from chronic CH, having reached a daily attack frequency equal or inferior to two, presenting a recurrence of attacks after J15, defined as more than two attacks per day
Time frame: 2009
number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30
Time frame: 2009
number of chronic patients presenting a daily attack frequency equal or inferior to two at J90
Time frame: 2009
HIT-6 scores, comparison between groups at J0 and J30
Time frame: 2009
tolerance of treatment : percentage of patients showing side effects
Time frame: 2009
safety of treatment: percentage of patients with serious adverse events
Time frame: 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Results publication: PubMed 21903477Leroux E, Valade D, Taifas I, Vicaut E, Chagnon M, Roos C, Ducros A. Suboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Oct;10(10):891-7. doi: 10.1016/S1474-4422(11)70186-7. Epub 2011 Sep 6.
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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.
Dominique VALADE, MD principal investigator
CHU Lariboisière, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ALTIM, cortivazol injections, PROAMP, subcutaneous serum physiological saline and Verapamil in people with Cluster Headache, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 27 Nov 2012. 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 France. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with a daily attack frequency equal or inferior to two for the period going from two days after third injection to four days after the third injection (time frame: 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804895, which also lists 1 linked publication.
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 27 Nov 2012.