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Completed

NCT Number: NCT00804895

Cluster Headache Cortivazol Injection (CHCI)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)

Paris, Île-de-France Region, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • patient unable to complete the schedule crisis
  • patient non-compliant or unable to follow the research protocol
  • women without contraception, pregnant, or nursing

Treatment and study plan

ALTIM, cortivazol injections

Drug

ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.

Other names: ALTIM, cortivazol injections greater occipital

PROAMP, subcutaneous serum physiological saline

Drug

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.

Verapamil

Drug

standard prophylactic treatment

Primary outcomes

  1. 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

Secondary outcomes

  1. total number of attacks on the J1-J15 period

    Time frame: 2009

  2. percentage of patients with a 50% or more decrease in attacks frequency at J15

    Time frame: 2009

  3. percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more

    Time frame: 2009

  4. interval between the first injection and appearance of a remission

    Time frame: 2009

  5. 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

  6. number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30

    Time frame: 2009

  7. number of chronic patients presenting a daily attack frequency equal or inferior to two at J90

    Time frame: 2009

  8. HIT-6 scores, comparison between groups at J0 and J30

    Time frame: 2009

  9. tolerance of treatment : percentage of patients showing side effects

    Time frame: 2009

  10. safety of treatment: percentage of patients with serious adverse events

    Time frame: 2009

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache

Acronym: CHCI

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 9, 2008
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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