Efficacy and safety of cortison for decreasing the frequency of cluster headache: a randomized study with placebo as comperator. All patients will receive as basic therapy Verapamil additionally to cortison.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006204-13-DE

Enrollment

144

Registered

2012-07-27

Start date

2013-01-17

Completion date

Unknown

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episodic Cluster Headache (ECH) MedDRA version: 18.0 Level: LLT Classification code 10009698 Term: Cluster headaches System Organ Class: 100000004852

Interventions

Trade Name: Prednison 20 mg GALEN® Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: Prednison Other descriptive name: Prednison 20 mg GALEN® Tabletten Concentration unit: mg milligram(s) Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Episodic cluster headache according to the IHS-criteria; previous duration of typical cluster period; previous cluster episodes should be longer than one month past; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 134 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: pregnancy/nursing; additional physical or psychological illnesses; contraindications for verapamil or prednisone treatment; chronic cluster headache; drug/alcohol abuse; diabetes mellitus; cardiac arrhythmia

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of oral prednisone or placebo for an acute bout in episodic cluster headache in patients. ;Secondary Objective: Further information about safety and efficacy of prednison in comparison to placebo.;Primary end point(s): Number of cluster attacks within the first week of treatment with prednisone compared to placebo;Timepoint(s) of evaluation of this end point: Day 1 to 7	—

Measure

Time frame

Main Objective: To investigate the efficacy of oral prednisone or placebo for an acute bout in episodic cluster headache in patients. ;Secondary Objective: Further information about safety and efficacy of prednison in comparison to placebo.;Primary end point(s): Number of cluster attacks within the first week of treatment with prednisone compared to placebo;Timepoint(s) of evaluation of this end point: Day 1 to 7

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Secondary

Measure	Time frame
Secondary end point(s): -CH episode abortion (i.e., pain free state) - Number of escape therapy doses - Frequency of CH attacks from day 1 to 28 - Responders (prednisone and placebo) - Level of disability in daily routine (questionairy SF-12, HIT-6, ADS) during screening and on day 28 - Occurrence of autonomic symptoms Days with cluster headache after day 7 till day 28 - Safety and acceptability of treatment - Pain intensity of attacks on a verbal rating scale (VRS, 0=no pain, 10=worst imaginable pain.) - Assessment of safety;Timepoint(s) of evaluation of this end point: Day 7 and day 28 as described above.	—

Measure

Time frame

Secondary end point(s): -CH episode abortion (i.e., pain free state) - Number of escape therapy doses - Frequency of CH attacks from day 1 to 28 - Responders (prednisone and placebo) - Level of disability in daily routine (questionairy SF-12, HIT-6, ADS) during screening and on day 28 - Occurrence of autonomic symptoms Days with cluster headache after day 7 till day 28 - Safety and acceptability of treatment - Pain intensity of attacks on a verbal rating scale (VRS, 0=no pain, 10=worst imaginable pain.) - Assessment of safety;Timepoint(s) of evaluation of this end point: Day 7 and day 28 as described above.

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Countries

Germany

Contacts

Public ContactClaudia Ose

ZKSE

claudia.ose@uk-essen.de+492017234519

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026