Conditions: Chronic Daily Headache
Keywords: intranasal oxytocin acute headache treatment chronic daily headache
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Treated group arm 2: Placebo group arm 3: None arm 4: None

Interventions: intervention 1: Syntocinon intervention 2: Sterile water intervention 3: Syntocinon intervention 4: Sterile water
Intervention descriptions: intervention 1: 4 actuations in each nostril for a total dose of 32 IU intervention 2: 4 actuations in each nostril intervention 3: 8 actuations in each nostril for a total dose of 64 IU intervention 4: 8 actuations in each nostril

Protocol document: