## Protocol Section
### Identification Module
**NCT ID:** NCT01402479

**Brief Title:** An Open-labeled Trial of Ramipril in Patients With Migraine

**Official Title:** An Open-labeled Trial of Ramipril in Patients With Migraine

#### Organization Study ID Info
**ID:** 0408-131-005
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2005-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-08-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-08-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-07

**Type:** ACTUAL

#### Start Date
**Date:** 2004-10

**Status Verified Date:** 2011-07

#### Study First Post Date
**Date:** 2011-07-26
**Type:** ESTIMATED
**Study First Submit Date:** 2011-07-24
**Study First Submit QC Date:** 2011-07-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University Hospital

#### Responsible Party

**Old Name Title:** Manho Kim, MD, PhD

**Old Organization:** Department of Neurology, Seoul National University Hospital

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated. Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators attempt to test the efficacy of ramipril on the prophylaxis of migraine attacks.

### Conditions Module

**Conditions:**

- Migraine With Hypertension

**Keywords:**

- migraine,

- ramipril,

- hypertension

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** open label single arm trial

**Intervention Names:**

- Drug: Ramipril

**Label:** ramipril

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ramipril

**Description:** ramipril 2.5mg twice a day

**Name:** Ramipril

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** headache days

**Measure:** headache frequency

**Time Frame:** 12 week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with chronic migraine are included in this study. Migraineurs should be aged 20 to 70 years old with the ability to read and understand the self-report scales, including the headache diary, used in this study.

Exclusion Criteria:

1. Medication overuse headache are excluded in this study.
2. Treatment with other ACEI or medication that may affect ARS
3. Treatment with migraine prophylactic medications or anti-hypertensive agents including β adrenergic receptor or calcium channel blockers
4. Past history of hepatic or renal dysfunction; an abnormal electrocardiography; a psychiatric disorder; a history of substance abuse; pregnancy or lactation; use of anti-psychotics, antidepressants, or anti-anxiety drugs.

**Maximum Age:** 70 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Zip:** 110-744

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000051270

- Term: Headache Disorders, Primary

- ID: D000020773

- Term: Headache Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M11852

- Name: Migraine Disorders

- Relevance: HIGH

- As Found: Migraine

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9351

- Name: Headache

- Relevance: LOW

- As Found: Unknown

- ID: M22529

- Name: Headache Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26657

- Name: Headache Disorders, Primary

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008881

- Term: Migraine Disorders

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Ancestors

- ID: D000000806

- Term: Angiotensin-Converting Enzyme Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000959

- Term: Antihypertensive Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M19553

- Name: Ramipril

- Relevance: HIGH

- As Found: Behavioral intervention

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4134

- Name: Angiotensin-Converting Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017257

- Term: Ramipril

### Misc Info Module

- Version Holder: 2024-05-24
