Trial document




drksid header

  DRKS00004716

Trial Description

start of 1:1-Block title

Title

Efficacy and safety of oral prednisone as add-on therapy in prophylactic treatment of episodic cluster headache: a randomized, placebo controlled parallel study.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PredCH

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.predch.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This study investigates the efficacy and safety of oral prednisone as an add-on therapy in an acute bout of episodic cluster headache in patients treated with Verapamil. Episodic cluster headache is characterized by recurrent bouts of unilateral severe headache attacks, followed by intervals without symptoms. Verapamil is proven to be an effective drug in the prophylactic treatment of cluster headache episodes, but has a delayed onset.
As the initial treatment of an episode, patients are often administered cortisol as a supportive therapy, although the beneficial effect of this has not yet been proven.
In this clinical trial patients with episodic cluster headache will be administered Verapamil and in addition to that either cortisol or a placebo; the acute treatment of cluster attacks (i.e. oxygen, triptanes) can be continued as usual.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

To investigate the efficacy and safety of oral prednisone in the prophylactic add-on treatment of an acute bout of episodic cluster headache in patients treated with verapamil.
Multi-centered, randomized, double blind, placebo-controlled-trial.
2 parallel groups: Verapamil plus prednisone as the add-on vs. Verapamil plus a placebo.
Both groups are prescribed pantoprazole and potassium to prevent prednisone side effects, such as gastric ulcer and hypokalemia.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004716
  •   2013/02/13
  •   [---]*
  •   yes
  •   Approved
  •   12-250-AF, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2011-006204-13 
  •   4038398 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G44.0 -  Cluster headache syndrome
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Treatment intervention: Prednisone orally administered as an add-on to the prophylactic treatment of episodic cluster headache. Prednisone capsules are produced at the pharmacy of the University of Heidelberg. Administration accords to the following scheme:

    Day 1-5 : 100mg (5x 20 mg) prednisone p.o. once daily
    Day 6-8: 80mg ( 4x 20 mg) prednisone p.o. once daily
    Day 9-11: 60mg (3x 20 mg) prednisone p.o. once daily
    Day 12-14: 40mg (2x 20 mg) prednisone p.o. once daily
    Day 15-17: 20 mg (1x 20 mg) prednisone p.o. once daily

    Basic therapy is prescribed by each study center: Verapamil P.O. (e.g. Isoptin) starting on the first day of study participation according to the following plan:

    Day 1-3: 40 mg - 40 mg - 40 mg/d
    Day 4-6: 40 mg - 40 mg - 80 mg/d
    Day 7-9: 40 mg - 80 mg - 80 mg/d
    Day 10 - 12: 80 mg - 80 mg - 80 mg/d
    Day 13 - 15: 80 mg - 80 mg - 120 mg/d
    Day 16 - 18: 80 mg - 120 mg - 120 mg/d
    Day 19 - End of trial: 120 mg - 120 mg - 120 mg/d

    Additionally:
    Potassium P.O. (as effervescent tablet) 1,56 g/d (e.g. Kalinor BT 1-0-0)
    and Pantoprazole P.O. 40 mg/d (e.g. Pantozol 40 mg 1-0-0)
  •   Placebo intervention:
    Placebo capsules P.O. as add-on therapy to the prophylactic treatment of episodic cluster headache with Verapamil.
    Day 1-5: 5 capsules placebo (5-0-0)
    Day 6-8: 4 capsules placebo (4-0-0)
    Day 9-11: 3 capsules placebo (3-0-0)
    Day 12-14: 2 capsules placebo (2-0-0)
    Day 15-17: 1 capsule placebo (1-0-0)

    Basic therapy is prescribed by each study center: Verapamil P.O. (e.g. Isoptin) starting on the first day of study participation according to the following plan:

    Day 1-3: 40 mg - 40 mg - 40 mg/d
    Day 4-6: 40 mg - 40 mg - 80 mg/d
    Day 7-9: 40 mg - 80 mg - 80 mg/d
    Day 10 - 12: 80 mg - 80 mg - 80 mg/d
    Day 13 - 15: 80 mg - 80 mg - 120 mg/d
    Day 16 - 18: 80 mg - 120 mg - 120 mg/d
    Day 19 - End of trial: 120 mg - 120 mg - 120 mg/d

    Additionally:
    Potassium P.O. (as effervescent tablet) 1,56 g/d (e.g. Kalinor BT 1-0-0)
    and Pantoprazole P.O. 40 mg/d (e.g. Pantozol 40 mg 1-0-0)

end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   patient/subject, therapist/clinician, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   Yes
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The number of cluster attacks within the first week of treatment with prednisone compared to a placebo, as documented in the headache diary.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

1. Number of cluster attacks from day 1 to day 28 of study participation.
2. Number of cluster attacks from day 7 to day 28 of treatment.
3. Episode abortion ( yes/no), defined as no further attacks in the last 3 days before check-up on day 7 or day 28
4. Number of intakes of acute medication until day 7 and until day 28.
5. Therapy response (reduction rate of total number of attacks >50%, as compared to day -3 till day 0, measured after 7 and 28 days) defined as number of attacks/day
6. Trigemino-autonomous symptoms (yes/no after 7 and 28 days)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/04/05
  •   144
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Male and female patients between18 and 65 year of age, of legal competence, with sufficient proficiency of written and spoken German. Willing and capable to attend regular follow-up.
Episodic cluster headache according to the IHS-criteria;patient has had at least one previous attack before, average duration of previous cluster episodes at least one month untreated, expected duration of cluster period after randomization should be at least one month after initiation of therapy;
previous cluster episodes should be longer than one month away; at least second cluster episode during life-time. Beginning of current bout of Clster headache less than 30 days ago. Last bout more than 30 days ago.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

No other prophylactic drugs than the study medication (prednisone) and verapamil within 30 days before inclusion into study.
Pregnancy and nursing. Other severe illnesss,
contraindication against prednison or verapamil; chronic cluster headache, Addiction to alcohol or other drugs, Diabetes mellitus, cardiac arrhythmia, osteoporosis, missing consent.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Essen Klinik für Neurologie
    • Mr.  PD Dr. med.  Mark  Obermann 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Essen Klinik für Neurologie
    • Mr.  Jan  Burmeister 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.