NCT00963040

Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache

The Effect of Intranasal Oxytocin on Headache Intensity and Headache-associated Symptoms in Patients Suffering From Chronic Daily Headache

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: MedVadis Research Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective, randomized, double-blind, parallel-group, placebo-controlled study is to determine the effectiveness of intranasal oxytocin in subjects suffering from chronic daily headache.

Detailed description

The TI004 and TI005 studies both used a randomized, double-blind, placebo-controlled, parallel-group study design. A protocol-specified interim analysis was performed after completion of the first 40 subjects, resulting in termination of the TI004 study and development of the TI005 protocol, which included the following changes from the TI004 protocol: 1. Increase in oxytocin dose from 32 to 64 IU; 2. Extension of the in-clinic observation period from 2 hours post-dose to 4-hours post-dose; 3. Reduction in sample size from 40 to 20 subjects; 4. Elimination of the laboratory measurements during the screening visit, allowing V1 and V2 potentially to be combined, expediting study completion; 5. Adding in-clinic observation and assessment at 3 hours and 4 hours post-dose and out-of-clinic assessment at 8 hours post-dose. The primary outcome measure is the reduction in headache intensity after drug administration; secondary outcome measures are the headache symptoms, nausea, vomiting, photophobia, and phonophobia. Additional secondary outcome measures are intake of rescue medication and patient satisfaction over a period of 24 hours.

Conditions

• Chronic Daily Headache

Interventions

Type	Name	Description
DRUG	Syntocinon	4 actuations in each nostril for a total dose of 32 IU
DRUG	Sterile water	4 actuations in each nostril
DRUG	Syntocinon	8 actuations in each nostril for a total dose of 64 IU
DRUG	Sterile water	8 actuations in each nostril

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-08-20
• Last updated: 2023-06-15
• Results posted: 2023-06-15

Locations

1 site across 1 country: United States