NCT00804895

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

10 months

First QC Date

December 8, 2008

Last Update Submit

November 23, 2012

Conditions

Cluster Headache

Keywords

cluster headachegreater occipital nerve blockcortivazol

Outcome Measures

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

    2009

Secondary Outcomes (10)

  • total number of attacks on the J1-J15 period

    2009

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

    2009

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

    2009

  • interval between the first injection and appearance of a remission

    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

    2009

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

subcutaneous injection of Cortivazol ALTIM, 3,375mg

Drug: ALTIM, cortivazol injectionsDrug: Verapamil

2

PLACEBO COMPARATOR

PROAMP, subcutaneous serum physiological saline

Drug: PROAMP, subcutaneous serum physiological salineDrug: Verapamil

Interventions

ALTIM, cortivazol injectionsDRUG

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

Also known as: ALTIM, cortivazol injections greater occipital
1
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.

2
VerapamilDRUG

standard prophylactic treatment

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

Related Publications (1)

  • 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.

    PMID: 21903477RESULT

MeSH Terms

Conditions

Cluster Headache

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Dominique VALADE, MD

    CHU Lariboisière, AP-HP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 9, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

FR(1)