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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00662935
Other study ID # 04 -APN -03
Secondary ID
Status Completed
Phase N/A
First received April 17, 2008
Last updated April 17, 2008
Start date May 2005
Est. completion date March 2008

Study information

Verified date April 2008
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the efficacy and safety of deep brain stimulation (DBS) in chronic and treatment-resistant CH. Inclusion criteria are: patients with chronic CH (>3years), with daily attack and non response to adequate treatment. Electrodes are implanted stereotactically in the postero-inferior hypothalamus. In this crossover, randomized, placebo-controlled double-blinded study, the efficacy of DBS is evaluated using comparison of two one-month sequences: one with stimulation "on" and the other with stimulation "off" (placebo sequence). Efficacy is defined as ≥50% decrease of weekly frequency of CH attacks. After the randomized period, long-term efficacy and safety are evaluated after one year of stimulation in open conditions.


Description:

Over the past 7 years, deep brain stimulation (DBS) has been used in various centres to treat patients with intractable chronic cluster headache (CH). Results in these non-controlled studies were encouraging but need to be confirmed in controlled conditions. The aim of this study is to evaluate the efficacy and safety of DBS in chronic and treatment-resistant CH, in randomized placebo-controlled conditions.

Inclusion criteria are: patients with chronic CH (>3years), with daily attack and non response to adequate treatment (verapamil up 960 mg/d, lithium with plasmatic level 0.6-1 mEq/ ml, and association of both drugs). After induction of local anaesthesia, electrodes are implanted stereotactically in the postero-inferior hypothalamus according to the previously described coordinates, and connected to a sub-cutaneous generator. In this crossover, randomized, placebo-controlled double-blinded study, the efficacy of DBS is evaluated using comparison of two one-month sequences: one with stimulation "on" and the other with stimulation "off" (considered as the placebo sequence). Primary efficacy is defined as ≥50% decrease of weekly frequency of CH attacks, compared to a prospective run-in pre-implantation period. Safety and tolerability are clinically and biologically assessed. After the randomized period, long-term efficacy and safety are evaluated after one year of stimulation in open conditions.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- between 18 and 65 year old

- suffering from cluster headache since 3 years at least

- not responding to others treatments such as : verapamil, lithium or both of them

Exclusion Criteria:

- patient with addiction

- pregnancy or feeding women

- contraindication to general anesthetic

- contraindication to MRI

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
setting-up of an electrode in deep brain
deep brain stimulation of the postero-inferoir hypothalamus

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice Medtronic

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease (=50% by reference to a prospective pre-implantation run-in period) of the weekly frequency of cluster headache attacks between treatment and placebo one-month sequences. between treatment and placebo one-month sequences. No
Secondary Intensity of dysautomic dysfunction, acute treatment consumption, quality of life Between treatment and placebo one-month sequences. Between treatment and placebo one-month sequences. No
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