Blockade of the nerve at the occiput in frequent migraine and headache induced by medication overuse

Blockade of the greater occipital nerve in frequent migraine and medication-overuse headache - a double-blinded, randomized, controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007336-17-AT

Enrollment

158

Registered

2009-07-16

Start date

2009-08-06

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

frequent migraine (defined at least 8 attacks per month) and medication-overuse headache

Interventions

Trade Name: Diprophos Product Name: Diprophos Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men or women, aged between 18 and 65 years - Headache diagnoses a) Study 1: Diagnosis of migraine without or with aura according to the criteria of ICHD-II (Tables 1 and 2) and eight or more days of migraine without aura or probable migraine without aura (Table 3) per month on average during the three months preceding study inclusion. b) Study 2: Diagnosis of MOH according to the revised criteria by Silberstein et al. (ICHD-IIR) - Prophylactic therapy of headache: No prophylactic medication and no non-pharmacological headache prophylaxis in the previous three months OR stable prophylactic therapy for three months continued without change throughout the entire study period. - Written informed consent 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 158 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Other headache disorders except tension-type headache - Lifetime history of moderate or severe traumatic brain injury or any other cerebral disorder - Mild traumatic brain injury in the previous year - Substance abuse and medication overuse: Study 1: Lifetime history of substance abuse and medication overuse as defined by Silberstein et al. in the previous year. Study 2: Lifetime history of substance abuse except overuse of acute headache medication. Unsuccessful withdrawal therapy for MOH in the previous year. Current overuse of opioids or benzodiazepines - Diabetes mellitus - Known Glaucoma - Uncontrolled hypertension - Known osteoporosis - Gastral or duodenal ulcer in the previous year - Severe liver disease - Obesity (BMI>30) - Current treatment with corticosteroids - Pregnancy or breastfeeding - Change of prophylactic headache treatment in past 8 weeks

Design outcomes

Primary

Measure	Time frame
Main Objective: This study was designed to assess the influence of blockade of the greater occipital nerve (ONB) on (1) the frequency of migraine in patients with eight or more migraine days per month, (2) hours with severe or moderate headache within the first 120 hours after withdrawal of acute medication and the proportion of responders to medication-withdrawal in patients with MOH;Secondary Objective: -Days with any headache -Duration of headache -Intensity of headache -Use of acute medication -Headache Impact Test -Beck Depression Inventory II (BDI) -Beck Anxiety Inventory (BAI) -Blood glucose levels -Need for another prophylactic treatment;Primary end point(s): Migraine: Reduction in days with migraine without aura or probable migraine without aura < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5-8, 9-12, 13-16) MOH: Reduction in das with moderate or severe headache < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5.8, 9-12, 13-16);Timepoint(s) of evaluation of this end point: Migraine: Reduction in days with migraine without aura or probable migraine without aura < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5-8, 9-12, 13-16) MOH: Reduction in das with moderate or severe headache < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5.8, 9-12, 13-16)	—

Measure

Time frame

Main Objective: This study was designed to assess the influence of blockade of the greater occipital nerve (ONB) on (1) the frequency of migraine in patients with eight or more migraine days per month, (2) hours with severe or moderate headache within the first 120 hours after withdrawal of acute medication and the proportion of responders to medication-withdrawal in patients with MOH;Secondary Objective: -Days with any headache -Duration of headache -Intensity of headache -Use of acute medication -Headache Impact Test -Beck Depression Inventory II (BDI) -Beck Anxiety Inventory (BAI) -Blood glucose levels -Need for another prophylactic treatment;Primary end point(s): Migraine: Reduction in days with migraine without aura or probable migraine without aura < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5-8, 9-12, 13-16) MOH: Reduction in das with moderate or severe headache < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5.8, 9-12, 13-16);Timepoint(s) of evaluation of this end point: Migraine: Reduction in days with migraine without aura or probable migraine without aura < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5-8, 9-12, 13-16) MOH: Reduction in das with moderate or severe headache < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5.8, 9-12, 13-16)

—

Secondary

Measure	Time frame
Secondary end point(s): - Days with any headache - Duration of headache - Intensity of headache - Use of acute medication - Headache Impact Test - Beck Depression Inventory II (BDI) - Beck Anxiety Inventory (BAI) - Blood glucose levels - Need for another prophylactic treatment;Timepoint(s) of evaluation of this end point: weeks 4, 8, 12 and 16	—

Countries

Austria

Contacts

Public ContactUniv. Klinik für Neurologie

Medizinische Universität Wien

christian.woeber@meduniwien.ac.at+431404003117

Outcome results

None listed

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